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Job Title: Supervisor Location: SBC Corporation Department Name: Lab NBI Req #: 0000234024 Status: Salaried Shift: Day Pay Range: $93,150.00 - $113,850.00 per year Pay Transparency: The above reflects the anticipated annual salary range for this position if hired to work in New Jersey. The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience. Step into a fast-paced, deeply rewarding role where the work you do truly matters. As the Laboratory Supervisor of the Blood Bank at Newark Beth Israel, you will be a key member of the patient care team and collaborate with physicians and other clinical professionals to contribute to safe and effective care. The Lab Supervisor may be the perfect role for you if you have strong leadership skills, knowledge of specialized principles and techniques in Blood Banking, and want to make a difference in the lives of our patients. If you are passionate about healthcare, eager to advance your skills, and motivated to make a tangible difference during every shift, this position provides the experience, challenge, and purpose you are seeking. As the Laboratory Supervisor of the Blood Bank at Newark Beth Israel, below are your key responsibilities: • Day-to-day operational oversight of the Blood Bank / Transfusion Services, • Ensure safe, accurate, and timely provision of blood and blood components, • This role provides technical leadership, staff supervision, regulatory compliance oversight, and quality assurance in accordance with AABB, CAP, CLIA, FDA, and hospital policies, • Perform or supervise complex immunohematology testing (ABO/Rh, antibody identification, crossmatching) and component modification (irradiation), • Review records of blood testing, processing, and transfusion reactions; manage Occurrence Report Forms for process improvement, • Supervises duties related to record documentation, consults with Medical Director and Administrative Director on regulatory compliance updates, • Participates in the administrative and budgetary operations of the section The Laboratory Supervisor role might be for you if you: • Have previous experience in Laboratory leadership at a high-volume healthcare facility, • Have previous experience working in a Blood Bank, • Excellent customer service, • Outstanding communication skills including verbal and written To be considered for this opportunity, you must have a Bachelor of Science or Medical Technology degree and Minimum of 3 years experience as a medical technologist. ASCP or NCA certification preferred. Benefits and Perks: At RWJBarnabas Health, our market-competitive Total Rewards package provides comprehensive benefits and resources to support our employees’ physical, emotional, social, and financial health. • Paid Time Off (PTO), • Medical and Prescription Drug Insurance, • Dental and Vision Insurance, • Retirement Plans, • Short & Long Term Disability, • Life & Accidental Death Insurance, • Tuition Reimbursement, • Health Care/Dependent Care Flexible Spending Accounts, • Wellness Programs, • Voluntary Benefits (e.g., Pet Insurance), • Discounts Through our Partners such as NJ Devils, NJ PAC, Verizon, and more! Choosing RWJBarnabas Health! RWJBarnabas Health is the premier health care destination providing patient-centered, high-quality academic medicine in a compassionate and equitable manner, while delivering a best-in-class work experience to every member of the team. We honor and appreciate the privilege of creating and sustaining healthier communities, one person and one community at a time. As the leading academic health system in New Jersey, we advance innovative strategies in high-quality patient care, education, and research to address both the clinical and social determinants of health. RWJBarnabas Health aims to truly make a unique impact in local communities throughout New Jersey. From vastly improving the health of local residents to creating educational and career opportunities, this combination greatly benefits the state. We understand the growing and evolving needs of residents in New Jersey—whether that be enhancing the coordination for treating complex health conditions or improving community health through local programs and education. Equal Opportunity Employer

Territory: Queens, NY - Psychiatry Target area for territory is Queens - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: all of Queens, NY as well the Great Neck portion of Nassau County, NY. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university., • 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience., • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually., • Self-starter, with a strong work ethic and outstanding communication skills., • Must be computer literate with proficiency in Microsoft Office software., • Must live within 40 miles of territory boundaries., • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Previous experience within a specialty product sales force., • Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder., • Documented successful sales performance., • Ownership and accountability for the development and execution of fully integrated account plans., • Strong analytical background, and experience using sales data reporting tools to identify trends., • Experience in product launches., • Previous experience working with alliance partners (i.e., co-promotions)., • Strong leadership through participation in committees, job rotations, panels and related activities. TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is specifically for those potential hires who will work or reside in the state of New York, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $125,000 - $147,000 and eligibility for a sales incentive target of $40,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

Territory: Manhattan South, NY - Neurology Target area for territory is Manhattan - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: 60th street and South. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. It’s a very exciting time to join our team as we lead the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager, you lead the promotion of our infusion product, driving demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the local market and partnering to deploy approved services necessary to meet the needs of each account/customer. Our Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply customer and data-based insights to build opportunities, develop strategy & tactics and prioritize resources to enhance territory effectiveness in competitive markets. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Engage with multi-disciplinary customers using a total office call approach to communicate value proposition of a new delivery method. Customer Development - Entrepreneurial mindset to gain access, build and maintain productive internal and external relationships through effective communication and collaboration based on customer needs and organizational goals. Payer Access - Ability to grasp sophisticated reimbursement and distribution processes in a complex coverage landscape. Anticipates and communicates impact on product portfolio to key internal and external partners and effectively addresses payer access issues (Medicare, Medicaid, Commercial) using Lundbeck resources. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Demonstrates a clear and detailed understanding of the disease state and its impact on customers and patients including the full range of treatment options available. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices. Accountability and adherence to corporate, FDA, and PDMA guidelines. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university., • 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience., • Ownership and accountability for the development and execution of a fully integrated account plans., • Self-starter, with a strong work ethic and outstanding communication skills., • Proven track record of consistent sales performance., • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually., • Must be computer literate with proficiency in Microsoft Office Software., • Must live within 40 miles of territory boundaries., • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Previous experience within a specialty product sales force., • Infusion/rare disease sales experience in both the Outpatient Infusion setting and Specialty Pharmacy channel with a strong understanding of pricing and reimbursement., • Neurology experience specific to migraine., • Experience in both the medical or specialty pharmacy benefit market., • Experience working with high influence customers in physician clinics, integrated health systems, infusion centers and alternative sites of care., • Product launch or expansion experience, particularly in a new therapeutic class., • Strong analytical background, and experience using sales data reporting tools to identify trends., • Strong leadership through participation in committees, job rotations, panels and related activities. TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to a regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $155,000 - $172,000 and eligibility for a sales incentive target of $41,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our _. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

Territory: Brooklyn South, NY - Neuroscience - Psychiatry Target city for territory is Brooklyn - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Prospect Heights, Coney Island, Bay Ridge and Flatbush. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! As a Neuroscience Account Manager, you lead the promotion of our psychiatry portfolio to Psychiatrist and Institutional Accounts such as community mental health centers and hospitals, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Neuroscience Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university, • 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience, • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually, • Self-starter, with a strong work ethic and outstanding communication skills, • Demonstrated skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network, • Must be computer literate with proficiency in Microsoft Office software, • Must live within 40 miles of territory boundaries, • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder, • Documented successful sales performance, • Ownership and accountability for the development and execution of fully integrated account plans, • Strong analytical background, and experience using sales data reporting tools to identify trends_, • Experience in calling on customers at a variety of call points, including offices, community mental health centers and hospitals, • Sales experience with buy & bill/injectable products, • Experience in product launches, • Previous experience working with alliance partners (i.e., co-promotions), • Strong leadership through participation in committees, job rotations, panels and related activities TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is specifically for those potential hires who will work or reside in NYC, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $135,000 - $165,000 and eligibility for a sales incentive target of $40,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our _. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

Territory: White Plains, NY - Neurology Target area for territory is White Plains - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Westchester, White Plains, and the Bronx. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. It’s a very exciting time to join our team as we lead the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager, you lead the promotion of our infusion product, driving demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the local market and partnering to deploy approved services necessary to meet the needs of each account/customer. Our Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply customer and data-based insights to build opportunities, develop strategy & tactics and prioritize resources to enhance territory effectiveness in competitive markets. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Engage with multi-disciplinary customers using a total office call approach to communicate value proposition of a new delivery method. Customer Development - Entrepreneurial mindset to gain access, build and maintain productive internal and external relationships through effective communication and collaboration based on customer needs and organizational goals. Payer Access - Ability to grasp sophisticated reimbursement and distribution processes in a complex coverage landscape. Anticipates and communicates impact on product portfolio to key internal and external partners and effectively addresses payer access issues (Medicare, Medicaid, Commercial) using Lundbeck resources. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Demonstrates a clear and detailed understanding of the disease state and its impact on customers and patients including the full range of treatment options available. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices. Accountability and adherence to corporate, FDA, and PDMA guidelines. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university., • 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience., • Ownership and accountability for the development and execution of a fully integrated account plans., • Self-starter, with a strong work ethic and outstanding communication skills., • Proven track record of consistent sales performance., • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually., • Must be computer literate with proficiency in Microsoft Office Software., • Must live within 40 miles of territory boundaries., • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Previous experience within a specialty product sales force., • Infusion/rare disease sales experience in both the Outpatient Infusion setting and Specialty Pharmacy channel with a strong understanding of pricing and reimbursement., • Neurology experience specific to migraine., • Experience in both the medical or specialty pharmacy benefit market., • Experience working with high influence customers in physician clinics, integrated health systems, infusion centers and alternative sites of care., • Product launch or expansion experience, particularly in a new therapeutic class., • Strong analytical background, and experience using sales data reporting tools to identify trends., • Strong leadership through participation in committees, job rotations, panels and related activities. TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $155,000 - $172,000 and eligibility for a sales incentive target of $41,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our _. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

Job Summary JOB SUMMARY Key contributor within the organization that monitors, maintains, and enhances risk controls by analyzing quality data and major quality events to ensure Medline is properly controlling risks on a global level for medical devices, cosmetics, and OTC drugs. Responsible for managing an automated risk-based trending system that will help the organization foresee risks as well as objectively proving that risk controls are effective. Provide expertise to the organization including education, technical support, issue resolution, and integration of new or enhanced risk controls to be compliant with EU MDR along with satisfying FDA, ISO 13485, and ISO 14971 risk management related processes throughout the product life cycle. Collaborate with Medline’s R&D team during design and development, manufacturing teams to implement appropriate risk controls, post-market surveillance teams to determine if new risks have arisen, and Regulatory Affairs to support FDA inspections. Job Description MAJOR RESPONSIBILITIES: Analyze and normalize multiple streams of data to gauge the health of the risk management system. Work with Subject Matter Experts (SMEs) to create a framework for Risk-based dashboards to be used for real-time decision-making and management reporting. Provide detailed input to stakeholders on how to implement risk controls as well as create and implement controls Identify inefficiencies in Medline’s global quality management system. Take action to address identified inefficiencies. Develop timelines for all projects and ensure that deadlines and goals are being met. Frequently update management and team on progress. Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion. MINIMUM JOB REQUIREMENTS Education Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree. Work Experience At least 2 years of QA/QE experience in a cGMP Device or environment. Complete device life cycle experience related to design, production, use of a device, and ISO 14971. Experience with Data visualization tools/business intelligence tools such as Tableau, Power BI, or Qlik. Experience leading multiple, complex projects. Knowledge / Skills / Abilities Strong ability to manage multiple priorities. Self-starter attitude. Good oral and writing skills. Ability to work independently and as a team in an efficient manner. PREFERRED JOB REQUIREMENTS Education Masters of Science – Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field. Certification / Licensure Six Sigma certification. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Medline is hiring a Senior Data Analyst to ensure high levels of data quality, integrity, and governance, enabling product recall, regulatory, and quality data to effectively support business operations and compliance requirements. This is an exciting opportunity to build high impact analytics, dashboards, and data governance solutions that directly support patient safety and FDA readiness across manufacturing, supply chain, and quality teams. Ideal for a hands on, senior analyst who thrives in regulated environments and wants to make a visible, enterprise level impact. Job Description Major Responsibilities Ensure high levels of data quality, integrity, and governance so product recall, regulatory, and quality data effectively support business operations and compliance requirements. Design, develop, and deliver post‑market surveillance and recall analytics, dashboards, tools, and insights to support patient safety, recall execution, and regulatory compliance. Establish and maintain master data standards, procedures, and a recalls reporting framework, including data collection, validation, governance, and a single source of truth aligned with applicable regulations and the Quality Management System (QMS). Analyze manufacturing, inventory, shipping, distribution, and customer data to identify affected products and customers and ensure end‑to‑end traceability during recall events. Support recall execution activities—including product holds, inventory containment, scrapping, return‑to‑vendor, and disposition or termination requirements—in partnership with Quality, Manufacturing, Supply Chain, Logistics, Customer Service, and Regulatory Affairs. Monitor, track, and report on data quality metrics; perform ongoing analysis, audits, and investigations to identify errors, risks, or gaps and drive corrective and preventive actions. Engage with business leaders to assess and communicate the business and regulatory impact of data quality issues or recall process gaps and recommend improvements. Identify, lead, and implement continuous improvement initiatives through process mapping, system enhancements, and adoption of best practices. Respond to time‑sensitive and escalated data and reporting requests related to recalls, quality events, and regulatory inquiries. Support FDA inspections and other regulatory agency inspections or information requests by providing accurate, well‑documented, and timely data. Maintain departmental SOPs and documentation related to data management, analytics, and reporting standards. Minimum Job Requirements Education Bachelor’s degree in a business‑related field such as business, supply chain, operations, engineering, or information systems. Work Experience 4+ years of experience in data management, data analysis, or reporting. Demonstrated experience driving data or tooling improvements from requirements gathering through validation and release. Prior experience working in a regulated industry required (medical device, MedTech, healthcare, pharmaceutical, or similar strongly preferred). Experience supporting product recalls, post‑market surveillance, quality events, or regulatory compliance activities preferred. Proven ability to work cross‑functionally and manage multiple priorities while delivering accurate results within tight timelines. Knowledge / Skills / Abilities Demonstrated knowledge of data manipulation, analytics, and reporting tools including Excel, SQL, Access, and Power BI / Microsoft Fabric. Experience developing data collection, automation, and reporting solutions, including use of Power Apps. Knowledge and experience with SAP, Smartsheet, and other ERP or reporting platforms. Strong understanding of data quality, governance, validation, and audit readiness in regulated environments. Ability to analyze complex information, prioritize critical data, and deliver clear, actionable insights. Strong communication skills with the ability to translate data for technical and non‑technical stakeholders. Experience driving continuous improvement initiatives and implementing process or system enhancements. Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint. Ability to work independently and provide leadership, coaching, and mentoring to others. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary The Regulatory Trade Compliance Manager is responsible for ensuring compliant and efficient importation of medical devices, medical kits, and other FDA-regulated products into the United States. This role serves as the primary bridge between Regulatory Affairs, Imports/Logistics, Legal, and Corporate Compliance to ensure that FDA import data and processes are accurate, consistent, and aligned across all internal systems, contract manufacturers, suppliers, and customs brokers. The position is being established to strengthen FDA import compliance and reduce detentions by creating standardized governance processes, improving data integrity, and developing effective working relationships with FDA import reviewers. The individual will own the end-to-end process for FDA import compliance, with a strong focus on ACE entry requirements, medical kit imports, and resolution of FDA Notices of Action. Job Description MAJOR RESPONSIBILITIES Serve as the Regulatory Affairs subject matter expert for FDA import requirements and ACE submissions for medical devices and medical kits. Provide regulatory guidance to Imports and Logistics teams to ensure accurate FDA data transmission through the Automated Commercial Environment (ACE). Oversee and validate FDA entry data elements including FDA Product Codes, Intended Use Codes, Affirmations of Compliance (AofC), Establishment Registration Numbers, Medical Device Listing (MDL) numbers, Manufacturer and importer identifiers. Act as the escalation point for complex FDA import questions and compliance determinations. Serve as the process owner for FDA import data integrity across the enterprise. Design and implement standardized processes to ensure consistency of FDA-critical data across Regulatory Affairs systems, ERP and master data systems, Trade compliance platforms, Broker instructions, Supplier and contract manufacturer documentation. Establish formal change-control processes to ensure that product updates, new listings, or regulatory changes are reflected in import data prior to shipment. Develop and maintain SOPs, work instructions, and internal controls related to FDA import compliance. Act as the internal expert on FDA import requirements for convenience kits, including determination of kit regulatory status, assignment of appropriate product codes, component-level listing considerations, multi-component admissibility requirements. Partner with Product Development, Sourcing, and Quality to ensure new or revised kits are structured and documented in a manner that supports FDA admissibility. Serve as the primary Regulatory Affairs contact for FDA detentions and Notices of FDA Action (NOAs). Lead root cause analysis and corrective actions to prevent recurrence of detentions. Partner with the Imports team to investigate and resolve FDA entry issues, including incorrect or inconsistent product codes, outdated or missing device listings, data discrepancies, supplier documentation gaps. Develop professional rapport with FDA import reviewers and compliance officers to facilitate timely resolution of entry reviews and questions. Track, trend, and report FDA detention metrics and drive continuous improvement initiatives. Partner with suppliers and contract manufacturers to ensure understanding of U.S. FDA import requirements. Support onboarding of new suppliers from an FDA import compliance perspective and ensure readiness prior to first shipment. Collaborate closely with Legal and Corporate Compliance teams to establish and maintain an enterprise governance framework for FDA import compliance. Participate in internal audits, compliance reviews, and investigations related to import activities. MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Regulatory Affairs, Life Sciences, International Trade, Supply Chain, or a related field Equivalent combination of education and experience will be considered Certification / Licensure Work Experience Minimum 5 years of experience in FDA-regulated industry Demonstrated experience creating and implementing business processes and governance controls Experience managing import compliance for medical kits / convenience kits Knowledge / Skills / Abilities FDA medical device import and registration requirements ACE entry submissions and troubleshooting Resolution of FDA detentions and Notices of Action Ability to analyze FDA entry failures and determine regulatory root causes Experience translating regulatory requirements into operational processes PREFERRED JOB REQUIREMENTS Certification / Licensure Customs Broker License or trade compliance certification Work Experience People management experience Experience interacting directly with FDA import compliance officers Experience with SAP GTS or similar trade compliance systems Background partnering with Legal and Compliance on governance initiatives Knowledge / Skills / Abilities Experience supporting FDA inspections or audits Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $116,000.00 - $174,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Title: Director, Regulatory Affairs Location: Remote Duration -3 months Description: Provides senior regulatory leadership and strategic guidance to support late-stage clinical development programs, ensuring alignment with global regulatory requirements. Acts as the primary regulatory lead for a fast-paced biotech environment, partnering cross-functionally to drive regulatory strategy through Phase III and preparation for potential registration. Key Responsibilities: Lead global regulatory strategy for Phase III clinical programs, with a focus on vaccines. Provide hands-on leadership for regulatory submissions and interactions (e.g., FDA, EMA), including NDA/BLA readiness where applicable. Serve as interim Regulatory Affairs Lead, ensuring continuity of ongoing programs and regulatory commitments. Advise internal stakeholders on evolving regulatory requirements and risk mitigation strategies. Support preparation, review, and delivery of high-quality regulatory documents and submissions. Act as key liaison with clinical, CMC, and executive teams in a high-pressure, fast-moving biotech setting. Qualifications: Extensive Regulatory Affairs experience (typically 12–15+ years) in biotech/pharma. Proven experience leading global regulatory strategy for Phase III clinical programs. Vaccine experience strongly preferred. Prior experience with NDA/BLA submissions or late-stage regulatory interactions is a plus. Demonstrated ability to operate effectively in fast-paced, high-pressure environments. Strong leadership, communication, and stakeholder management skills.

NEW Vice President Clinical Development Opportunity! This Jobot Job is hosted by: Audrey Block Are you a fit? Easy Apply now by clicking the "Quick Apply" buttonand sending us your resume. Salary: $350,000 - $400,000 per year A bit about us: We are a small biotech located in the greater Boston area. We are hiring a VP of Clinical Development with a strong background in Ophthalmology or Dermatology, and we ideally want someone with strong Phase II experience. Please apply if you fit the criteria below! Why join us? Competitive compensation Stock options Flexible schedule Established team with strong funding Opportunity for growth Job Details Job Details: Our company is seeking a Vice President of Clinical Development Ophthalmology to lead our team. This is an exceptional opportunity for a seasoned professional to apply their expertise in a dynamic and innovative environment. The successful candidate will be responsible for overseeing the clinical development of our therapeutics in the field of ophthalmology. This role requires a minimum of 5 years of experience in clinical development. Responsibilities: 1. Lead and manage the clinical development team in the design, execution, and interpretation of clinical studies. 2. Develop and implement clinical development plans for ophthalmic products, ensuring alignment with business objectives. 3. Maintain a thorough understanding of FDA regulations, GCP, and BLA processes, and ensure all clinical activities are compliant. 4. Collaborate with cross-functional teams including regulatory affairs, pharmacovigilance, and medical affairs to ensure a holistic approach to product development. 5. Direct the preparation of clinical portions of regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). 6. Oversee the selection and management of Contract Research Organizations (CROs) and other external vendors. 7. Present clinical development plans, study results, and project updates to senior management, regulatory agencies, and other stakeholders. 8. Keep abreast of emerging models in healthcare delivery; identify and define new and innovative strategies to achieve business goals and objectives. Qualifications: 1. MD, DO, or equivalent degree with a specialty in Ophthalmology would be ideal. 2. Minimum of 5 years of experience in clinical development within the pharmaceutical or biotech industry. 3. Proven experience with FDA regulations, Good Clinical Practice (GCP), and Biologics License Applications (BLA). 4. Strong knowledge of clinical trial design, implementation, and data interpretation. 5. Excellent leadership and team management skills, with the ability to inspire and motivate a diverse team. 6. Exceptional communication skills, both written and verbal, with the ability to articulate complex scientific concepts to a variety of audiences. 7. Proven ability to manage multiple projects, prioritize tasks, and meet deadlines. 8. Strong strategic thinking, problem-solving, and decision-making skills. 9. Willingness to travel as required. This role offers an exciting opportunity to contribute to our mission of improving patient lives through the development of innovative ophthalmic therapies. If you are a strategic thinker, a strong leader, and a dedicated professional with a passion for clinical development, we would love to hear from you. Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. 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Job Summary Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Lead the authoring and executing of protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results. In addition, this role will coach and assist Pharma Validation Engineers through the validation process. Job Description Responsibilities: Responsible for revalidation, engineering studies to evaluate new products or components, change control assessments, and coordination of computer and method validations of applicable products in an FDA controlled environment. Plan, communicate and lead scientifically sound qualification/validation strategies for large scale projects. Perform engineering studies to determine if projects are feasible. Suggest OEE Improvements and suggestions as a member of the continuous improvement team. Communicate with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regard to the needs and status of assigned study execution activities. Manage vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols. Provide coaching and mentoring to Pharma Validation team. Develop, prepare and install equipment and revise test validation procedures/protocols to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices. Develop and execute cleaning validations. Responsible for IQ/OQ and PQ phases. Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols. Develop timelines for all projects and ensure that deadlines and goals are being met. Frequently update management and team on progress. Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion. Compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements. Maintain all of the documentation pertaining to qualification and validation of assigned projects and equipment/systems. Qualifications: Bachelor of Science Degree in Biology, Chemistry or Engineering. At least 4 years of validation experience in a cGMP Device or Drug environment. Experience with validations of USP water, controlled environments or equipment validations in a regulated environment. Experience with validation documentation and related change control. Ability to control and coordinate concurrent projects, competing priorities and critical deadlines. Experience assessing and initiating actions independently. Experience taking charge of a situation, team or project. Ability to build and maintain relationships within and between teams. Strong oral and writing skills. Preferred Qualifications: Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field. Six Sigma certification. Validation experience in a pharmaceutical or Medical Device manufacturing environment. Experience with NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) products. Experience with validation of various product types such as liquid products, solid dosage products, and multi-component products. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $73,000.00 - $110,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary This role must be located in the Chicagoland area. Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full spectrum of Medline products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories. Perform internal audits of Medline divisions and manufacturing sites. Job Description MAJOR RESPONSIBILITIES: Plan, schedule and execute complex supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR, and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio (including APIs, sterile products, medical devices, cosmetics, pharmaceuticals, biologics, medical foods, and dietary supplements), as well as contract sterilizers, laboratories and raw material suppliers. - Evaluate Medline suppliers to determine approval status. Assist in development of Regulatory/Quality Management Systems for potential suppliers. Manage and participate in quality initiatives to maintain and improve compliance, such as evaluate internal processes, suggest and implement improvements, and create and revise applicable procedures and SOPs. Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Medline specifications, including novel products and services. - Plan, schedule and execute internal audits in accordance with applicable FDA regulations, ISO standards, and other global regulatory requirements. Conduct adequate CAPA follow-up for supplier and internal audits. Write audit reports and communicate results to upper management. Provide training and consulting services to internal departments to comply with Quality Management System requirements. Assist in the review and writing of responses to observations issued by FDA or other regulatory agencies. Aid in preparation for FDA inspections and/or audits by other regulatory agencies for both Medline facilities and suppliers. Plan and coordinate travel for supplier and internal audits, both domestically and internationally. Education Bachelor’s degree in microbiology, chemistry, engineering or related field. Work Experience At least 2 years of experience auditing FDA regulated medical device or pharmaceuticals manufacturing or testing OR at least 3 years working in quality role within medical device or pharmaceutical manufacturing. Knowledge / Skills / Abilities Detail-oriented, with excellent oral and written communication skills. Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions. Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary. Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines. Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally). Preferred Qualifications: Experience with FDA regulations (21 CFR 820, 21 CFR 210/211). Experience with ISO 13485. Experience applying knowledge of process validation, method validation and sterilization processes. Experience in CAPA (Corrective and Preventive Actions) management. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Job Description JOB SUMMARY: Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full spectrum of Medline products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories. Perform internal audits of Medline divisions and manufacturing sites. Lead complex, critical, supplier regulatory projects involving cross-functional teams. MAJOR RESPONSIBILITIES: - Act as senior team leader to support Supplier QA Management and facilitate strategic achievement of Supplier Quality goals. - As a Subject Matter Expert, provide training and consulting services to internal departments to understand and comply with Quality Management System requirements. - Plan, schedule and execute complex and high-risk supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio (including APIs, sterile products, medical devices, cosmetics, pharmaceuticals, biologics, medical foods, and dietary supplements), as well as contract sterilizers, laboratories and raw material suppliers. - Evaluate Medline suppliers to determine approval status. Assist in development of Regulatory/Quality Management Systems for potential suppliers. - Plan, schedule and execute complex internal audits in accordance with applicable FDA regulations, ISO standards, and other global regulatory requirements. - Conduct adequate CAPA follow-up for supplier and internal audits. - Write audit reports and communicate results to upper management. - Plan and coordinate all travel for both supplier and internal audits, both domestically and internationally. - Assist in the review and writing of responses to observations issued by FDA or other regulatory agencies. - Aid in preparation for FDA inspections and/or audits by other regulatory agencies for both Medline facilities and suppliers. - Manage and participate in quality initiatives to maintain and improve compliance, such as evaluate internal processes, suggest and implement improvements, and create and revise applicable procedures and SOPs. - Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Medline specifications, including novel and high-risk products and services. - Assist in integration of new acquisitions into Medline’s quality system. Perform due diligence audits for potential acquisitions. - Provide mentoring, coaching, and training to junior auditors, divisional QA team members, and divisional QA Managers. Assist in managing the rotational QA program. Education - Bachelor’s degree in microbiology, chemistry, engineering or related field. Work Experience - At least 4 years of experience auditing FDA regulated medical Device or pharmaceuticals OR at least 5 years working in senior level quality role within medical device or pharmaceutical manufacturing. - Experience with FDA regulations (21 CFR 820, 21 CFR 210/211). - Experience with ISO 13485. - Experience applying knowledge of process validation, method validation and sterilization processes. Knowledge / Skills / Abilities - Detail-oriented, with excellent oral and written communication skills. - Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions. - Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary. - Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines. - Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally). PREFERRED JOB REQUIREMENTS - Experience with USP 61/62 for Microbial Testing of Non-Steriles. - Experience applying knowledge of process validation, method validation and sterilization processes. - Experience in CAPA (Corrective and Preventive Actions) management. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $92,000.00 - $138,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Ad Promo Regulatory Advisor Job Number: 26-00770 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for an Ad Promo Regulatory Advisor for our client in Princeton Pike, NJ. ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity! Position Overview: The Ad Promo Regulatory Advisor plays a critical role in ensuring that all U.S. advertising, promotional materials, and external communications for marketed pharmaceutical products comply with FDA regulations and industry standards. This position partners closely with cross functional teams to provide strategic regulatory guidance, assess risk, and support compliant product promotion in a fast paced, matrixed environment. Responsibilities: Regulatory Review & Strategic Guidance: Provide expert regulatory advice and risk assessments on a broad range of advertising and promotional materials, sales training content, and external communications for assigned marketed products. Compliance Assurance: Ensure all promotional activities adhere to FDA regulations, approved product labeling, OPDP advisory comments, and relevant guidance documents. Partner with internal teams to proactively identify and mitigate regulatory risks. Regulatory Intelligence: Maintain current knowledge of U.S. federal and state laws, regulations, enforcement trends, and policy developments affecting pharmaceutical advertising and promotion. Translate regulatory changes into practical business guidance. OPDP Submission Management: Prepare and submit promotional materials to FDAs Office of Prescription Drug Promotion (OPDP) on Form FDA 2253, ensuring accuracy, completeness, and timeliness. Labeling Alignment: Collaborate with cross-functional partners and management teams to ensure updates to U.S. Prescribing Information are consistently reflected across all promotional materials and campaigns. Required Qualifications: Bachelor’s degree in a Life Science discipline required; advanced degree strongly preferred (MS, PhD, PharmD, or JD). Regulatory Experience: Minimum of 5-6 years of regulatory promotional review experience within the pharmaceutical or biotechnology industry. Expertise in Promotional Regulations: Demonstrated experience providing strategic regulatory direction to interdisciplinary teams on promotional strategies and materials. Strong interest and knowledge of FDA promotional regulations and guidance. Industry or FDA Experience: Broad hands on pharmaceutical experience or prior FDA regulatory experience (e.g., OPDP) is highly desirable. Project & Stakeholder Management: Proven ability to manage multiple complex projects, identify and resolve issues, deliver on commitments, and work effectively across multidisciplinary teams. Leadership & Organizational Skills: Strong leadership presence with the ability to influence, drive alignment, and deliver optimal business results in a dynamic, matrixed environment. Pay Rate: $95.82 - $101.63 / Hour If hired, you will enjoy the following ECLARO Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO If interested, you may contact: June Binuya junethel.binuya@eclaro.com 212-804-7476 June Binuya | LinkedIn Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

Job Summary Under limited supervision, the Senior Regulatory Specialist is responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. Responsible for developing solutions to re-solve complex regulatory issues and for leading multifunctional teams in high-priority projects. Job Description MAJOR RESPONSIBILITIES: In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s). Identify factors that could impact the success or viability of new product launch in assigned market(s). Monitor changes in regulations that impact current or future requirements and overall compliance. Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways, strategies, and solutions for specific products and scenarios. Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards. Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators. Participate in the development, review, and substantiation of product labeling and claims. Manage individual projects by providing direction on diverse regulatory pathways, defining timelines for tasks and project teams, and recommending future actions and solutions. Assist in the review and development of processes related to regulatory activities of responsibility. Assist in the establishment and maintenance of department databases, logs, and files necessary for ensuring ongoing compliance. Actively participate in internal and external audits when applicable. Education B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related. Work Experience At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets. Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files. Experience preparing responses and communicating with regulatory agencies. Knowledge / Skills / Abilities Understanding of the current Regulatory environment and demonstrating the ability to perform within. Applied knowledge of FDA regulations and guidelines. Ability to evaluate information to determine compliance with standards, laws, and regulations. - Position requires up to 10% travel. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $92,000.00 - $138,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Responsible for planning and executing regulatory activities and projects necessary to ensure compliance with state and federal licensing requirements for the distribution of drugs, medical devices, and other regulated products. Assist with development of policies and procedures, systems, and strategies related to regulatory licensing compliance. May review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete department goals. Job Description Responsibilities In support of business priorities, determine the requirements for obtaining and complying with state and federal licenses for the distribution of prescription drugs, medical devices, home medical equipment, and other regulated products. Prepare, complete, and submit licensing applications and documents to state and federal regulatory agencies. Research federal, state, or local licensing requirements through review of laws and regulations or by direct contact with regulatory authorities. Develop and implement improvements to processes and procedures related to licensing requirements. Communicate the requirements of regulations to internal or external customers Prepare routine reports, dashboards, and summaries for licensing compliance tracking. Collaborate with cross-functional teams to deploy quality processes and systems. Implement and coordinate the use of electronic documentation systems and train personnel. Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert. Provide training to team members and other internal departments on Medline licensing procedures and processes. Required Experience Bachelor’s degree or a combination of education and experience At least 2 years of experience in regulatory affairs, licensing, quality assurance, quality, compliance, or legal. Knowledge / Skills / Abilities Intermediate skill level in Microsoft Suites (Excel, Word, Visio, Access, PowerPoint, Project). Ability to evaluate information to determine compliance with standards, laws, and regulations. Experience with Quality Management Systems and Document Control. Applied knowledge of state pharmacy/ wholesale drug distributor laws, NABP Drug Distributor Accreditation, FDA regulations, DSCSA, and other laws and regulations related to drug and medical device distribution. Experience collaborating with internal resources and external resources. Experience working through details of a problem, overcoming obstacles, and reaching a positive and successful solution Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $73,000.00 - $110,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary JOB SUMMARY This role will be the senior lead contributor within the organization that creates, monitors, maintains, and enhances risk controls by analyzing quality data and major quality events to ensure Medline is properly controlling risks on a global level for medical devices, cosmetics, and OTC drugs. This individual will collaborate with clinical, design engineering, regulatory, labeling, and international partners to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. Provide expertise to the organization including education, technical support, issue resolution, and integration of new or enhanced risk controls to be compliant with EU MDR along with satisfying FDA, ISO 13485, and ISO 14971 risk management related processes throughout the product life cycle. Job Description MAJOR RESPONSIBILITIES Create and align global risk management processes to ensure that risks are being analyzed consistently. Evaluate the risks and act as an approver for the following processes: Change Controls, Failure Mode Effect Analysis (FMEA), Medical Device Reporting (MDR), Recalls, Health Hazard Evaluations (HHEs), and other major quality events. Effectively communicate risks to senior global management. Build effective relationships with quality and business partners. Lead cross-department collaboration with R&D, Manufacturing, and other sites on a global level to ensure all risks are adequately addressed with robust risk controls. Create and manage systems to analyze multiple streams of data to gauge the health of a quality or risk management system. Work with Subject Matter Experts (SMEs) to create a framework for Risk-based dashboards to be used for real-time decision-making and management reporting. Provide detailed input to stakeholders on how to implement risk controls as well as create and implement controls Identify inefficiencies in Medline’s global quality management system. Take action to address identified inefficiencies. Lead and ensure that deadlines and goals are being met. Frequently update management and team on progress. Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion. MINIMUM JOB REQUIREMENTS Education - Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree. Work Experience - At least 4 years of QA/QE experience in a cGMP Device or environment. - At least 2 years of direct risk management experience related to FDA regulated products. - Experience creating quality sub-systems and leading complex projects. Knowledge / Skills / Abilities - Ability to manage 5+ projects at a time. - Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as a team in an efficient manner. PREFERRED JOB REQUIREMENTS Education - Masters of Science – Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field. Work Experience - At least 5 years of QA/QE experience in a cGMP Device or environment. Certification - Six Sigma certification. Knowledge / Skills / Abilities - Working understanding of FDA, GMP, ISO 13485, and ISO 14971 - Experience facilitating FMEAs - Systems or clinical engineering experience Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $92,000.00 - $138,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Support Medline’s Supplier Quality operations by executing supplier qualification, monitoring, and performance activities for a global supply base. This role assists with supplier assessments, documentation review, audits, and issue resolution to ensure compliance with FDA regulations, ISO standards, and internal quality system requirements. The position partners cross functionally while developing foundational expertise in supplier quality and regulatory compliance. Job Description MAJOR RESPONSIBILITIES Conduct supplier audits to verify compliance with ISO 9001, ISO 13485, and applicable regulatory requirements related to high-risk vendors Support supplier qualification, requalification, and disqualification activities for moderate to high‑risk suppliers, including documentation review and approval routing Review and approve supplier quality records and compliance documentation in accordance with internal procedures Execute Supplier Corrective Action Requests (SCARs) by tracking actions, verifying evidence, and documenting effectiveness under supervision Assist with supplier communication related to quality requirements, documentation requests, and corrective actions to Medline’s internal business partners and external suppliers Provide technical guidance and training to suppliers on quality standards and best practices Support containment activities and investigations related to supplier nonconformances Utilize root cause analysis and risk management tools to prevent recurrence of issues Maintain accurate and timely records of supplier audits, performance reviews, nonconformances, and corrective actions Prepare routine reports, dashboards, and summaries for supplier quality performance and compliance tracking MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Engineering, Biology, Quality Management, or related field Work Experience 3–5 years in supplier quality, manufacturing quality, or similar role Knowledge / Skills / Abilities Knowledge of ISO standards, FDA regulations (if applicable), statistical process control (SPC), and quality tools (FMEA, PPAP, APQP) Strong communication, problem-solving, and negotiation skills Medical Device or drug experience Travel up to 25% (domestic and/or international) PREFERRED JOB REQUIREMENTS Certification / Licensure ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional Six Sigma Green Belt or higher Work Experience Supplier quality auditing Audit hosting experience Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Lead Medline’s supplier quality oversight for a global supply base. Own risk‑based qualification, performance management, scorecards, and audit execution for high‑risk suppliers; act as SME on purchasing controls (21 CFR 820 §820.50 and ISO 13485:2016 7.4) and represent Supplier Quality during internal/external inspections. Drive cross‑functional corrective and preventive actions and supplier development to improve quality, reliability, and compliance. Job Description MAJOR RESPONSIBILITIES Lead risk‑based supplier oversight across regions; set audit/monitoring depth by risk tier and product classification. Lead communication efforts related to high-risk suppliers with internal stakeholders. Own complex supplier qualifications and disqualifications for critical suppliers, including technical documentation reviews and potential on‑site assessments. Author and maintain supplier quality agreements and inspection plans with Procurement/Legal; ensure alignment with device regulations and regional requirements. Own the supplier scorecard program for assigned categories; analyze trends and drive SCAR/CAPA to effectiveness verification; escalate per governance. Work with quality support groups (ex. Risk Management, Design and Development, Post-Market Surveillance, etc) to proactively identify issues and lead the containment of them. Lead partnership with procurement, engineering, and operations teams to resolve supplier-related quality issues. Provide technical guidance and training to suppliers on quality standards and best practices. Troubleshoot in-depth vendor issues that impact multiple business units to improve the global supply chain and improve supplier processes. Mentor Quality Engineers/QEDP associates and coach divisional QA on supplier controls, SCAR quality, and problem‑solving methods. Maintain accurate records of audits, performance reviews, and compliance reports. Oversees scorecard program and executive quality metric dashboards Assist or perform audits associated with high-risk suppliers to ISO 13485, ISO 9001, and/or and applicable regulatory requirements. MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Engineering, Biology, Quality Management, or related field. Work Experience 6-8 years in supplier quality, manufacturing quality, or similar role. Knowledge / Skills / Abilities In-depth knowledge of ISO standards and FDA regulations Strong communication, problem-solving, and negotiation skills Ownership of CAPA or SCAR throughout its lifecycle Strong Medical Device or Drug regulatory experience Strong critical thinking abilities Experience with statistical process control (SPC), and quality tools (FMEA, PPAP, APQP). Travel up to 25% (domestic and/or international) PREFERRED JOB REQUIREMENTS Education Masters of Biology, Chemistry, Engineering, Quality Management, or similar field Certification / Licensure ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional Six Sigma Green Belt or higher Work Experience Front or backroom FDA or ISO audit experience Supplier quality auditing Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $101,000.00 - $152,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

BARDA / Nonclinical Data Standards and Analytics Program/Technical Advisor (Mid-level) Description of Role: The Biomedical Advanced Research and Development Authority (BARDA) within the office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services (HHS) improves national preparedness for chemical, biological, radiological, and nuclear (CBRN) accidents and attacks, pandemic influenza, and emerging infectious diseases by supporting the development and acquisition of medical countermeasures (MCM) against these threats. BARDA is looking for a Nonclinical Data Standards and Analytics Program/Technical Advisor to support the Division of Nonclinical Development (DNCD), Data Operations Program. The ideal candidate is excited to develop, implement, and manage a data quality and compliance management program for contracted nonclinical research across BARDA’s programs and provide subject matter expertise in nonclinical data standards and advanced analytics to support the development and implementation of a Nonclinical Data Coordination Center (DCC) platform tool. This position focuses on implementation and governance of DCC datasets structured according to an extensive professional experience in CDISC Standard for the Exchange of Nonclinical Data (SEND), with emphasis on SEND Implementation Guide – Animal Rule (SENDIG-AR), 2019, and alignment with FDA Guidance 'Product Development Under the Animal Rule. This is a full-time, remote position that requires the ability to obtain Public Trust; Tier 2 clearance. Required Qualifications: Advanced degree (e.g., Ph.D., M.P.H., M.S.) in biological and/or chemical sciences such as medicine, pharmacy, life science fields (e.g., immunology, molecular biology, biochemistry, microbiology, or similar) Minimum eight (8) years of relevant industry and/or relevant postdoctoral experience in regulatory data standards and analytics Direct SEND implementation experience Client-focused approach to work; Ability to prioritize workload Ability to work well with a multi-disciplinary team of professionals; Flexible attitude with respect to work assignments and new learning Preferred Qualifications: Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred Experience with applying statistical and epidemiologic methods to nonclinical datasets, including survival analysis and cross-study integration a plus Quality control and quality assurance experience with nonclinical datasets a plus Responsibilities: Serve as technical SME for CDISC SEND and SENDIG-AR (2019) Develop validation criteria, business rules, and quality control procedures for DCC ingestion of SEND datasets Support design and implementation of DCC data architecture and metadata governance frameworks Establish data acceptance and rejection criteria aligned with regulatory expectations Contribute to DCC end user interface testing and acceptance criteria Assist in developing end user training and implementation plans Ensure alignment with Animal Rule regulatory requirements (21 CFR 314.600 and 601.90) Assist other contractors by translating regulatory requirements into operational data standards specifications Quality control of dataset packages Integrate knowledge of nonclinical study conduct to assure correct dataset output Knowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for dataset packages Communicate findings to team members and management Obtain proficiency with DNCD quality control workflows to include regulatory dataset [e.g. SEND] review, study report QC, and other reviews, as required Adhere to and/or assist in establishment/refinement of DNCD SOPs and business practice documents related to QC efforts Learn data audit practices with possibility to assist in remote data audits of BARDA contracted research Provide technical expertise to individual advanced research and development (ARD) and/or nonclinical project coordination teams (PCTs). Act as the primary data management contact for BARDA ARD/nonclinical PCTs supporting contracts issued to CHEM, RADNUC, and BIOLOGICAL network contract research laboratories (CROs) Coordinate with PCTs to determine intended use for data derived from contract(s) and establish data management plans intended to ensure data are fit for purpose Coordinate with PCTs to ensure data management plans are included within contract management plans and quality assurance project plans established by CRO contractors Develop strong PCT relationships that are driven by consistent study data analytic and management services in terms of quality and timeliness Advise CRO contractors on data delivery and format requirements Receive and review raw data from CRO contractors for completeness and quality according to established quality control standards Coordinate with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs #CB

Job Description Who We Are: Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click's treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click's platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn. About the Role: As a Senior Director / Vice President of Market Access, you will be the backbone of the commercial organization. You will design the financial architecture of the product, shape the external policy and regulatory environments to support PDTs, and ensure long term viability of the PDT category. The role reports to the Chief Commercial Officer and will work closely with senior counterparts in the Medical Office and Strategy Office. We are looking for someone with a strong background in Policy and Market Access Operations to also develop the Click playbook for Prescription Digital Therapeutic (PDT) launches across multiple therapeutic areas. This position is based out of Click's headquarters located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities. We have a hybrid working model that consists of at least 4 days in office each week. Responsibilities: • Pricing & Contracting Strategy, • Architect and execute comprehensive US pricing strategies, including WAC-to-Net modeling and multi-year GTN (Gross-to-Net) forecasting to ensure sustainable brand profitability, • Design and negotiate innovative contracting frameworks to secure optimal formulary positioning., • Lead the Deal Evaluation process, utilizing rigorous financial sensitivity analysis to balance market share gains against rebate ceilings and price-protection liabilities.Reimbursement & Operations, • Engineer end-to-end payment flows that bridge the gap between contract execution and claims adjudication, ensuring seamless provider and pharmacy reimbursement., • Oversee operational pathways for claims processing, proactively identifying and resolving "bottlenecks" in the medical or pharmacy benefit triggers to minimize script abandonment.Patient Support & Distribution, • Design and scale the "Hub" infrastructure and Digital Pharmacy partnerships to optimize patient onboarding and speed-to-therapy., • Implement a high-touch patient contact model (Care Guides/Coaches) leveraging RWE (Real-World Evidence) to drive therapy persistence and long-term outcomesCommercial Effectiveness & Data Strategy, • Own the commercial data ecosystem, integrating real-time app data with traditional claims data, • Establish key performance indicators (KPIs) to monitor pull-through effectiveness, ensuring field teams are prioritizing the highest-yield payer segments., • Drive call planning, reach and frequency for sales team to execute in the field Government Affairs & Advocacy, • Lead lobbying efforts and advocacy coalitions to advance statutory coverage (e.g., Access to Prescription Digital Therapeutics Act) and shape the federal PDT landscape, • Develop and execute localized market access plans to open coverage pathways for specialized populations (e.g., Schizophrenia), navigating state-specific PDL (Preferred Drug List) processesCoding, Billing & Reimbursement Policy, • Coding & Compendia Management: Lead the strategy for HCPCS, CPT, and ICD-10 coding alignment; oversee successful listing in key drug compendia (First Databank, Medi-Span) to ensure automated billing, • Payer Dossier Development: Develop AMCP dossiers and Budget Impact Models (BIM) that substantiate the clinical and economic value proposition to P&T committees, • Policy Influence: Serve as the primary internal expert for PDURS (Prescription Drug Utilization Review) and Physician Fee Schedule updates to ensure long-term payment recognition Qualifications: At Click, we aren't just looking for talent; we are looking for the next evolution of the modern professional. To us, AI is not a future possibility, it is a present-day prerequisite. We expect every Click colleague to have seamlessly integrated AI into their professional workflow and personal productivity, using it as a force multiplier to move faster, think deeper, and deliver superlative results that were previously out of reach. If you do not yet view AI as an essential partner in your daily pursuit of excellence, you will find it impossible to keep pace with our mission. High performers who harness AI technology to transcend traditional boundaries and set new benchmarks for professional excellence will thrive at Click. • Bachelor's degree required; MBA, PharmD, or MPH preferred to navigate the complex intersection of business and clinical strategy, • 15+ years of progressive leadership within the pharmaceutical sectors, with a proven track record across Market Access and Pharma Commercial Operations, • Demonstrated success leading multiple brand launches, overseeing the journey from pre-approval market shaping to post-launch pull-through, • Strategic capabilities with the ability to conceive, develop and implement multi-dimensional roadmaps and business plans, • Deep understanding of the US payer landscape, with a preferred focus on Medicaid, state government accounts, and public affairs policy to navigate evolving legislative environments, • Sophisticated understanding of cross-functional ecosystems, including Sales, Marketing Analytics, Account Management, and Pricing and Contracting, • Exceptional communication and interpersonal skills, with the "emotional intelligence" required to drive consensus across diverse cultures and complex matrixed disciplines. Click Preferred Qualifications: • Knowledge of or experience with Digital Therapeutics and/or Prescription Digital Therapeutics is considered a plus, • Experience in other commercial functions (Marketing, Sales Enablement) Compensation: The base salary range for this position is between $180,000 - $280,000. The final base salary will be dependent upon skills, experience and location. In addition to the base salary, Click Therapeutics offers an annual performance-based cash bonus and a generous equity package. Benefits: The role includes great benefits and is an excellent wealth-building opportunity at a fast-growing pre-IPO company in a nascent and extremely exciting space. Competitive Salary with Annual Review | Cash Bonus | Stock Options | 5% 401(k) matching | Medical | Dental | Vision | Life Insurance | Voluntary Benefits | Unlimited PTO | Uber One | Nectar Rewards | One Medical | Fertility Support | Fitness Reimbursement | Bike Membership | Professional Development Stipend | DoorDash and Catered Lunches | Parent Benefits | LinkedIn Learning | Gemini Enterprise Stack | Industrious Workspaces | Commuter Subsidies | Flexible Work Arrangement | Choice of Mac or Windows | Sponsored Company Events | Office Snacks and Beverages | Much More… Equal Employment Opportunity: Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics. Recruitment Phishing Scams: Fake job advertisements and offers are increasingly appearing on the internet. If you have encountered a job posting or have been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond and report it to the Federal Trade Commission and the FBI at https://www.ic3.gov/Home/ComplaintChoice. Please be mindful of the following: • Click Therapeutics will only reach out to you through an "@clicktherapeutics.com" email address.Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver's License Number) via a messaging application (like that used on the LinkedIn platform or Microsoft Teams)., • Click Therapeutics will conduct interviews face-to-face over Zoom., • All job postings will be listed on the Click Therapeutics official career page.

Job Description Role Summary Lexeo is seeking an experienced and motivated professional to lead and build our Clinical Operations function as a key member of our development team. This individual will report to the Chief Medical Officer and will ensure that studies are completed on time and within budget in accordance with corporate objectives. This is a hands-on role and will be required to build excellent working relationships with various internal and external groups. If you enjoy being a part of a growing team and an entrepreneurial environment in which your work will have a meaningful impact on clinical trial progress for novel gene therapies, we want to hear from you! Primary Responsibilities • Collaborate with Lexeo CMO, R&D leadership, Weill Cornell research staff, Lexeo clinical, quality, and regulatory colleagues, CRO partners and other vendors to conduct clinical trials that meet corporate goals, • Evaluate and develop optimal outsourcing model for implementation of trials including selection of CROs and other vendors/ external partners. Oversee development of requests for proposals, negotiate and approve contracts and work orders, and review invoices prior to submission for approval, • Develop, maintain, and report on program budgets, including long-range forecasting, in support of Lexeo’s financial goals, • Monitor study-specific timelines, key deliverables, and implement strategies to optimize the efficiency of trial conduct, • Provide oversight of the CROs to avoid issues or rapidly adapt to challenges of feasibility/start up, slow recruitment, resourcing, site management, etc. Required Skills and Qualifications, • Advanced degree preferred and 10+ years of experience in the pharmaceutical or biotech industry within clinical operations and trial management, • Experience leading global clinical trials; rare disease/gene therapy trial experience preferred, • Thorough knowledge of development program management from IND- through NDA/BLA, including inspection readiness, • Extensive experience in CRO/ vendor selection and oversight, budget projection and management, establishing clear milestones, ensuring high-quality data delivery and report generation, • Advanced working knowledge of all relevant guidelines, including ICH, GCP, FDA, • Experience working in a fast-paced environment, • Excellent communication skills and ability to influence across multiple functions Compensation is dependent on qualifications and experience About Lexeo Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact. Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home. Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Position R&D Regulatory Compliance (Entry level) Department R&D Classification Non-Exempt Reports to Director of R&D and Technical Sales Job type Full-time (on-site) Job Summary This role combines regulatory compliance and hands-on product development within a fast-paced food manufacturing environment. You will support food labeling compliance while also assisting in the creation of innovative seasoning blends alongside the R&D team. Responsibilities include reviewing and preparing product labels and documentation to ensure compliance with FDA, USDA, and international regulations, as well as maintaining accurate records and supporting audits. This is a hands-on, non-routine role ideal for a detail-oriented and motivated individual eager to gain real-world experience in both regulatory compliance and food product development. You’ll collaborate with cross-functional teams and play a key role in bringing new food products from concept to market. Key Responsibilities: • • Assist in creating and reviewing product labels and specifications, • • Ensure compliance with food regulations and customer requirements, • • Support documentation for domestic and international products, • • Research regulations and help resolve labeling questions, • • Work with cross-functional teams (marketing, operations, etc.), • • Maintain accurate records and support audits or compliance checks, • • Help improve internal processes and compliance procedures What We’re Looking For • • Basic knowledge of food labeling regulations (FDA, USDA, and international), • • Strong research and problem-solving skills, • • Detail-oriented with good organization and time management, • • Able to handle multiple tasks and adapt in a fast-paced environment, • • Good communication and teamwork skills, • • Proficient in Microsoft Office (Excel, Word, PowerPoint), • • Bachelor’s degree in Nutrition, Food Science, or related field, • • Some experience or internship in food labeling or regulatory work preferred Why This Role Stands Out This is a rare opportunity to break into the food industry in a meaningful way. You won’t just observe—you’ll actively contribute, learn rapidly, and gain hands-on experience that can accelerate your career. We are looking for individuals who are ready to work hard, stay curious, and grow. Work Location: 1835 Burnet Ave, Union NJ 07083 Compensation/ Benefits • • Competitive base and bonus, • • 401k, • • Medical, Dental, Vision, • • Life Insurance and AD&D, • • 12 Holidays, • • 7 Flexible days, • • 10 Vacation Days and more This is an excellent opportunity to kick-start your career in the field of culin ry research and development. If you are enthusiastic, reliable, and excited about contributing to the creation of unique and flavorful seasoning blends, we encourage you to apply for the Seasoning Blending Lab Technician position." Our Motto: One Team – One Goal The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Furthermore, they do not imply or establish a contract for employment and are subject to change at the discretion of the employer. EEO Statement: Kalustyan Corporation and its subsidiaries is an equal opportunity employer which does not discriminate on the basis of race, color, sex, sexual or affectional preference, gender, sexual orientation, gender identity or expression, religion, creed, ancestry or national origin, age, disability, marital or domestic status, veteran status, genetic information, atypical hereditary cellular or blood trait, or any other protected class. This policy applies to all employment actions including but not limited to, recruitment, selection, training, promotion, transfer, layoff, termination, and job-related social or recreational programs. If you need a reasonable accommodation for any part of the employment process, please contact us by email at hr@kalustyan.com and let us know the nature of your request and your contact inormation Requests for accommodations will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

HCLTech is looking for a highly talented and self- motivated SAP Life Sciences Portfolio Lead to join it in advancing the technological world through innovation and creativity. Job Title: SAP Life Sciences Portfolio Lead Job ID: 39100 Position Type: Full-time Location: Remote w/travel Overview We are seeking an experienced SAP Life Sciences Portfolio Lead to drive strategic growth, delivery excellence, and client engagement across our SAP Life Sciences portfolio. This role combines business leadership, solution expertise, and delivery oversight to expand market presence and ensure successful execution of complex SAP transformation programs within the life sciences sector. Key Responsibilities Portfolio Leadership & Growth • Own and grow the SAP Life Sciences portfolio, including revenue, pipeline, and profitability, • Develop and execute go-to-market strategies aligned with industry trends (e.g., digital manufacturing, compliance, AI, and data platforms), • Identify and pursue new business opportunities, including large SAP S/4HANA, BTP, and RISE programs, • Build and maintain strong relationships with C-level stakeholders (CIO, CTO, CFO, Business Leaders) Client Engagement & Advisory • Serve as a trusted advisor to life sciences clients on digital transformation strategies, • Provide thought leadership on regulatory compliance (GxP), validation, and quality systems within SAP landscapes, • Lead executive discussions, proposals, and solution positioning for complex deals Delivery Oversight • Oversee end-to-end delivery of SAP programs across the portfolio, ensuring quality, timelines, and financial performance, • Ensure adherence to industry standards and regulatory requirements (FDA, EMA, GxP, CSV), • Manage risks, escalations, and governance across multiple engagements, • Drive adoption of best practices, accelerators, and delivery frameworks Practice & Capability Development • Build and scale high-performing teams across functional, technical, and industry domains, • Develop capabilities in SAP S/4HANA, BTP, AI/ML, data & analytics, and digital supply chain, • Mentor leaders and create succession pipelines within the practice Innovation & Thought Leadership • Lead initiatives around AI, automation, and advanced analytics in life sciences (e.g., clinical, manufacturing, supply chain), • Contribute to industry solutions, accelerators, and reusable assets, • Represent the organization at industry forums, conferences, and client events Required Qualifications • 15+ years of experience in SAP consulting/delivery, with significant focus on Life Sciences (pharma, biotech, medical devices), • Proven experience leading large SAP transformation programs (S/4HANA, ECC to S/4, RISE with SAP), • Strong understanding of GxP, CSV, regulatory compliance, and validation processes, • Experience managing P&L, portfolio delivery, and large teams, • Demonstrated success in business development, sales pursuits, and client relationship management, • Deep knowledge of SAP ecosystem (S/4HANA, BTP, supply chain, manufacturing, quality, finance) Preferred Qualifications • Experience with SAP Digital Manufacturing, ATTP, IBP, or Clinical solutions, • Exposure to AI/ML, data platforms (SAP Datasphere), and automation tools, • Background in global delivery models and multi-vendor environments, • MBA or relevant advanced degree Key Competencies • Strategic thinking and business acumen, • Executive presence and stakeholder management, • Delivery leadership and operational excellence, • Innovation mindset and continuous improvement Pay and Benefits Pay Range Minimum: $139,000 base per year Pay Range Maximum: $286,000 base per year HCLTech is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to secure@hcltech.com for investigation. A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year How You’ll Grow At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

Director, GMP QA (CMC/Development) – Permanent – New York Proclinical is seeking a Quality Systems Director for an emerging biotech company based in New York. Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities. The position is based onsite in New York. Skills & Requirements: • B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional., • Experience in small molecule development, batch release, and SOP drafting., • Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections., • Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products., • Proven ability to build or scale quality systems in a dynamic environment., • Prior experience managing CDMOs and external quality oversight strongly preferred., • Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred. The Director, GMP QA (CMC/Development) will: • Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards., • Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies., • Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations., • Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management)., • Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams., • Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs)., • Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

Director, GMP Quality Assurance Location: Remote EmploymentType: Contract (9-12 months+) Hourly Rate - $100-125HR Scientific Search has partnered with an innovative biotechnology organization seeking an experienced Director, GMP Quality Assurance to provide strategic and operational QA leadership supporting biologics manufacturing, analytical testing, stability programs, and external partner oversight. This individual will play a key role in ensuring GMP compliance, supporting quality systems, and driving cross-functional collaboration across manufacturing, quality control, regulatory, and supply chain activities within a fast-paced clinical-stage environment. Responsibilities Manufacturing & Analytical QA Oversight • Provide GMP QA oversight for drug substance and drug product manufacturing activities conducted at external CMOs, including batch record review and approval, • Review and approve GMP analytical methods, test protocols, and associated documentation generated at external contract laboratories, • Provide quality partnership and oversight for biologics manufacturing, testing, and product disposition activities, including combination products Stability Program QA Oversight • Provide QA oversight of stability programs for drug substance and drug product activities, including review and approval of stability protocols, reports, and supporting data, • Partner with Clinical QC teams to ensure stability study design and execution align with ICH guidelines and applicable regulatory commitments Reference Standard QA Oversight • Oversee QA activities related to reference standard qualification, characterization, and requalification, • Review and approve reference standard protocols and reports while ensuring proper chain of custody, storage, and release documentation General QA & Cross-Functional Collaboration • Support compliance within Quality Management Systems and external CDMO manufacturing/testing operations in accordance with FDA and global GMP regulations, including 21 CFR Parts 4, 210, 211, 820 and EU GMP guidelines, • Collaborate cross-functionally with CMC, Manufacturing, Analytical Testing, Quality Control, Regulatory CMC, Clinical Operations, and Supply Chain teams, • Review and verify quality-related documents, records, protocols, reports, and data supporting biologics programs and products, • Identify, assess, and escalate quality risks while driving compliant resolutions and continuous quality improvement initiatives, • Contribute to the development and refinement of quality processes, procedures, and organizational quality culture Requirements • Bachelor’s degree in scientific discipline or related field required, • 10–15 years of progressive GMP Quality Assurance experience within biotech, pharmaceutical, or biologics environments, • Strong experience overseeing external CDMO/CTO manufacturing and testing operations, • Hands-on expertise supporting QA oversight of QC operations, manufacturing, analytical testing, and supply chain activities, • Strong working knowledge of FDA and global GMP regulations and quality systems, • Experience supporting biologics and/or combination products strongly preferred, • Excellent communication, collaboration, and problem-solving skills within matrixed organizations, • Ability to support occasional evening meetings based on business needs How To Apply We’d love to see your resume, but we don’t need it to have a conversation. Email tom@scientificsearch.com or message me directly to learn more. • REMOTE

Hudson Regional Health System (HRHS) seeks a results-driven and collaborative laboratory leader to oversee outpatient diagnostic and clinical laboratory operations the system. The Director is accountable for ensuring regulatory compliance, service quality, and operational efficiency across outpatient services, supporting HRHS’s mission of delivering exceptional, patient-centered care. Position Summary The Director of Outpatient Lab Services manages all outpatient laboratory functions for Hudson Regional Health, including technical operations, process improvement, strategic growth, compliance, and financial performance. This position is based in Hudson Regional Health - Bayonne University Hospital while ensuring consistency, quality, and innovation across all outpatient lab functions and working in close collaboration with the inpatient Director and other lab supervisors. This position reports directly to the HRH-Bayonne University Hospital Chief Hospital Executive. Key Responsibilities · Oversee daily operations of outpatient clinical laboratory services · Ensure full compliance with CLIA, CAP, Joint Commission, OSHA, FDA, and applicable state regulations. · Supervise outpatient laboratory teams, including supervisors, technical personnel, and phlebotomists. ·Maintain appropriate staffing, scheduling, and budgetary controls to ensure cost-effective performance. · Collaborate with hospital executives, medical directors, outpatient facilities, and clinical departments to support patient care initiatives. · Lead continuous quality improvement and performance optimization efforts. · Manage equipment procurement, service contracts, and laboratory supply chains necessary for successful outpatient lab functions. · Partner with IT and system teams to standardize data, reporting, and laboratory information systems. · Track and report KPIs, turnaround times, and quality metrics to system leadership. · Participate in HRHS system-level meetings and cross-facility standardization initiatives. Leadership & Collaboration · Serve as the administrative and operational leader for outpatient laboratory services. · Collaborate directly system executives to align goals and share best practices. · Work closely with other HRHS laboratory leaders to advance system standardization and integration. · Promote employee engagement, professional development, and a culture of continuous improvement. Qualifications · Bachelor’s degree in clinical laboratory science, Medical Technology, or related field required; Master’s degree preferred. · Current licensure and national certification (ASCP, NCA, or AMT) required. · Minimum 7 years of progressive experience in laboratory management, including multi-site leadership preferred. · Outpatient and Reference Lab experience required. · Deep understanding of regulatory requirements, budget management, and process improvement methodologies. · Exceptional interpersonal and leadership skills, with the ability to collaborate effectively across departments. Job Type: Full-time Work Location: In person Benefits: • 401(k), • Dental insurance, • Flexible schedule, • Health insurance, • Paid time off, • Tuition reimbursement, • Vision insurance

🔷 Now Hiring: Corporate Paralegal (Contract) 🔷 📍 Location: 10022, New York (Onsite, 5 days/week) 💲 Pay Rate: $40.00–$45.00/hour We are seeking a Corporate Paralegal to support the legal and compliance operations of a growing medical device company. This position plays a critical role in managing contract workflows, supporting regulatory documentation, and maintaining corporate governance processes in a highly regulated environment. The Paralegal will work closely with Attorneys and cross-functional teams, contributing to the efficiency and accuracy of legal operations while ensuring compliance with industry standards. This is a hands-on role with consistent exposure to contract lifecycle management, FDA-related documentation, and internal legal processes in a fast-paced, high-demand setting. 🔧 Key Responsibilities: • Draft, review, and manage contracts including NDAs, vendor, clinical, consulting, and commercial agreements, • Track and manage contract lifecycle processes (CLM) including renewals, approvals, and deadlines, • Coordinate contract workflows across internal stakeholders and assist with negotiations, • Support regulatory documentation and filings related to FDA, EU MDR, and ISO 13485 standards, • Maintain organized contract logs and assist with document management systems (DMS), • Support corporate governance activities including filings, records, and board materials, • Conduct legal research and assist with drafting legal correspondence and documentation ✅ Qualifications: • Minimum 2+ years of experience in a legal or paralegal role, • Experience with contract drafting, review, and lifecycle management (CLM), • Prior exposure to life sciences, healthcare, or medical device industry preferred, • Strong organizational skills with high attention to detail, • Ability to manage multiple priorities in a fast-paced environment, • Proficiency in Microsoft Office and familiarity with document management systems ⚠️ Additional Requirements: • Must be able to work onsite 5 days/week, • Overtime and weekend work are expected as part of the role, • Comfortable working in a high-volume, deadline-driven environment If you’re looking to step into a role with strong ownership, regulatory exposure, and direct attorney collaboration, this is a great opportunity to grow within the life sciences space.

About the Role As the Knowledge & Innovation Lawyer for the Life Sciences practice, you are an experienced lawyer who will be a member of one of the legal industry’s leading Knowledge & Innovation (K&I) groups, known for award-winning and innovative KM systems and approaches. Working as an embedded Knowledge & Innovation Lawyer within the Life Sciences practice, you will work closely with the practice leaders and will draw upon your legal expertise and prior experience to support this group by providing the highest quality legal content and know-how for our U.S. practitioners. The firm's Life Sciences practice represents life sciences companies throughout the corporate life cycle — from startup to maturity — as well as investors, banks, and others in the life sciences ecosystem. Our comprehensive life sciences coverage includes complex financing and M&A transactions, capital market transactions, collaborations and licensing, regulatory and compliance diligence and advisory services, FDA litigation, patent prosecution, counseling, due diligence, and portfolio strategy, corporate governance, among many other areas. The Practice is particularly focused on the distinct legal and market dynamics of the life sciences sector, serving innovative companies, investors, and institutions at every stage of the product development lifecycle. Responsibilities • Drafting, updating and managing model documents, precedents, checklists, benchmarking surveys, market trend reports, and other substantive content for the Practice, ensuring such content is up-to-date and readily accessible on the firm’s intranet and other content-sharing platforms., • Work with Life Sciences partners to author and publish thought leadership content, including client-facing newsletters, deal trend analyses, and regulatory updates curating and analyzing industry developments for the life sciences sector; in addition to circulating internal market updates to the Life Sciences practice., • Serve as a source of legal, regulatory, market and practical expertise; identifying and collecting key data points of the Practice’s legal work for statistical analysis and post-deal assessments, benchmarking and market trends., • Monitor and proactively alert the Practice of important legal, regulatory and market developments relevant to the Life Sciences practice, including developments in FDA regulation, biologics, clinical trials, and transactional market trends; supporting the writing and publication of external client alerts on such developments., • Supporting the evaluation, pilot testing, and responsible use of Generative AI tools by the Life Sciences practice, including assessing use cases, gathering lawyer feedback, developing workflows and prompts, and contributing to pilot programs., • Develop curriculum for, and participate in, training initiatives for the Practice, including internal training sessions, client workshops, and other firm educational training programs., • Work with the Knowledge & Innovation team to develop solutions to increase efficiency, enable legal project management and improve legal service delivery of the Practice; such as generative AI templates and workflows, document assembly packages, expert systems and client-facing solutions., • Participate in K&I team meetings to facilitate the sharing of best practices and knowledge, and perform such other duties as requested by the K&I Department., • Assist in business development efforts for the Practice, including thought leadership initiatives, client seminars and pitches, to elevate the awareness and value of the Practice and the firm’s K&I program. Qualifications • Juris Doctor required., • 5+ years legal experience within the life sciences practice of a large law firm or as a life sciences industry expert, with substantive transactional experience in areas such as joint ventures, collaboration agreements, clinical trial arrangements, material transfer agreements, and/or biologics. Required Skills • Passion for knowledge-sharing, efficiency and excellence in legal work, and prior experience as a knowledge and/or innovation practitioner within a law firm or in-house legal department preferred., • Well established understanding of the life sciences transactional market and its distinct legal and regulatory dynamics., • Experience using AI in the performance of legal services and strong interest in working with legal technology, such as artificial intelligence, document automation, and collaboration platforms. Pay range and compensation package $250,000

Company Profile Founded in 1997 by Thierry Gillier, Zadig&Voltaire is a French contemporary designer brand known for redefining luxury with a bold, modern perspective offering fashion for both women and men. Rooted in freedom and creative audacity, the brand draws inspiration from contemporary art, rock & roll, a Parisian spirit, and self-empowerment, values that inform everything we do, from design to the way we collaborate, innovate, and grow our teams. The spirit of the brand is eternally youthful, encouraging its community to embrace individuality and self-expression while practicing self-love, taking bold steps, and living on their own terms. Zadig&Voltaire is dedicated to nurturing the talents of tomorrow and supporting the development of its employees' skills across all the countries where the brand is present. True to its founders’ vision, the company is guided by an artistic and entrepreneurial mindset where employees are encouraged to be agile and proactive within a fast-growing global brand. Zadig&Voltaire fully embraces the complex challenges of the 21st century by actively engaging in its global sustainability program VoltAIRe. As an evolving global brand, Zadig & Voltaire is looking for talented people to get involved. Zadig & Voltaire is an equal opportunity employer. Overview We are seeking a detail-oriented Import/Export & Customs Compliance Specialist to manage international shipments while ensuring full compliance with applicable customs regulations. This role partners closely with logistics providers, customs brokers, and internal teams to drive the efficient and compliant movement of goods into and out of North America. The ideal candidate brings strong operational execution along with hands-on expertise in U.S. customs compliance, classification, and cost optimization. Key Responsibilities Logistics Operations • Own day-to-day execution of international shipments (air, ocean, and ground) from factories to distribution center., • Coordinate with Paris headquarters, freight forwarders, carriers, and customs brokers to ensure on-time delivery., • Track shipments and proactively resolve delays, customs holds, discrepancies, and damage claims., • Optimize routing, transit times, and freight costs while enforcing routing guides and vendor compliance standards., • Develop and maintain shipment tracking tools to monitor time-to-market and logistics spend., • Issue export documentation and ensure completeness and accuracy of shipping paperwork., • Review and validate freight invoices and customs entries for accuracy, ensuring proper recording in internal systems., • Develop and maintain SOP for logistics and compliance processes, • Assist with operations activities as needed. Customs Compliance • Ensure compliance with all applicable import/export regulations, including requirements from U.S. Customs and Border Protection., • Classify products using HTS codes; determine country of origin and MID requirements in collaboration with Paris headquarters., • Manage pre-classification processes, and work with U.S. Customs Brokers to identify and resolve potential Quota, F&WL, or tariff issues., • Review and approve commercial invoices, packing lists, and other customs documentation., • Audit CBP Form 7501 for accuracy; manage duty payments (ACH/PMS) and post entry adjustments., • Maintain records for North America in accordance with regulatory requirements and support internal/external audits., • Support duty optimization programs (e.g., free trade agreements, duty drawback), • Support Headquarters with regulatory requirements for North and South America (e.g., FDA, CPSC, FTC, USDA). Reporting & Systems • Track and analyze KPIs (on-time delivery, clearance times, logistics cost)., • Maintain accurate data in M3 and Winddle., • Generate reporting and insight for leadership on shipment activity and compliance metrics. Required Experience and Skills • 3-5 years of experience in import/export and US Customs Compliance (fashion apparel/footwear, or retail supply chain preferred)., • Strong knowledge of international shipping processes, Incoterms, and customs procedures., • Hands-on experience with HTS classification and import/export documentation., • Knowledge of duty savings programs and trade agreements., • Experience working with freight forwarders and customs brokers, • Bachelor's degree or equivalent experience in related field., • Advanced Excel skills (Pivot Tables, VLOOKUP required)., • Strong analytical and problem-solving capabilities., • High attention to detail, accuracy and organization., • Effective communication across global teams., • Ability to manage multiple priorities in a fast-paced environment., • Proactive, solutions-oriented mindset with a focus on continuous improvement. Job Type: Full-time Benefits: • 401(k), • Dental insurance, • Health insurance, • Life insurance, • Vision insurance, • Unlimited Time Off Schedule: • Monday - Thursday HQ, • Friday Work from Hom

Job Description About Down East Seafood For over 30 years, Down East Seafood has been a go-to source for the freshest, highest-quality seafood among New York’s most celebrated chefs. What began as a single van sourcing clams from Maine has grown into a full-line seafood operation, delivering sustainably sourced selections six days a week across the Tri-State area. Based in a 17,000-square-foot facility in the heart of Hunt’s Point, the Bronx, Down East combines local expertise with coastal reach—providing premium seafood to restaurants in NYC, Westchester, Long Island, Southern Connecticut, and Northern New Jersey. With a commitment to freshness, traceability, and chef-focused service, Down East continues to bring the ocean’s bounty straight to the back of house. Pay Range: $25.00–$30.00 per hour Schedule: Sunday through Thursday into Friday 10:00 PM – 6:30 AM Position Summary: The FSQA Specialist will support the effective implementation of the Quality Management System and serve as the local technical resource at the facility. The HACCP Coordinator will support the ongoing review & development of all HACCP and quality assurance programs and ensure they meet applicable regulations and standards. What you’ll do: • Develop and implement local site documents with oversight from direct supervisor., • Interact with State, FDA and Shellfish inspectors to ensure ongoing compliance with federal regulations along with timely resolution of deficiencies as needed., • Support facility compliance to policy and regulations through onsite monitoring and/or verification activities., • Knowledge in wet sanitation and pre-operational monitoring procedures. Conduct/Review Pre-op inspection records as required., • Maintain readiness for Third Party GMP audit, • Schedule and deliver local site Food Safety including CCPs, Food Defense, and Quality Management system training per schedule., • Assist in investigation of customer complaints. Support Corrective actions as needed., • Organizes and maintains HACCP records, verification of HACCP observations as required in the HACCP Plan(s) and verifies all elements of the HACCP Plan as required., • Conduct HACCP reassessments as required annually or when there are changes in the facility or equipment or raw materials, • Provide FSQA support to internal projects (e.g. new items, new equipment installation, etc.), • Assist in production and packaging where needed to learn and understand the entire process, • Performs inspection procedures at frequencies identified in programs, procedures, and specifications., • Perform routine inspections of the environment and facility to ensure regulatory requirements and HACCP, GMP, SSOP procedures are met. Reports information., • Ensures product that fails to meet expectations or program requirements is retained and appropriate personnel are notified, • Prepares and presents HACCP training to all appropriate personnel and files all QA and HACCP documents. Audits all HACCP documentation on a regular basis., • Performs other duties as necessary in support of business objections. About you: • Bachelor’s degree in Food Science, Microbiology, or related field highly preferred. Minimum education GED or HS diploma, • Minimum of three years of quality assurance experience in manufacturing highly preferred., • Knowledge of seafood regulations, GMP’s, food safety audits, process procedures and documentation. GFSI audit experience highly preferred., • Excellent written and verbal communication skills., • Proficient in Microsoft Office Suite., • Organization: able to manage multiple projects; able to determine project urgency in a practical way, • Seafood HACCP certified or ability to gain certification within 6 months of hire. The above job description is not an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties as assigned by their supervisor. Perks & Benefits: • Paid Vacations, Paid Holidays, • Health, Dental and Medical Benefits, • Weekly pay, • Life Insurance, • 5% above cost for our high-quality food products, • Employee discounts for travel and events, • 401k, • Employee Stock Purchase Plan The Chefs' Warehouse is an Equal Opportunity Employer that does not discriminate based on actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, pregnancy, gender identity or any other characteristic protected by applicable federal, state, or local laws. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment. We are dedicated to building an inclusive and diverse workforce.

The Director of Molecular Diagnostics serves as the CLIA Laboratory Director for NYGC's clinical molecular diagnostics laboratory. This role provides clinical and scientific leadership for a CLIA-certified, CAP-accredited laboratory performing next-generation sequencing (NGS)-based genetic and oncology testing. The Director is responsible for the clinical validity, regulatory compliance, and operational excellence of all laboratory testing activities. This includes oversight of assay development and validation, quality management systems, regulatory compliance, personnel competency, and clinical interpretation and reporting of molecular diagnostic tests. The Director ensures compliance with CLIA, New York State Department of Health (NYS CLEP), CAP, and other applicable federal and state regulations, including licensure requirements for laboratories providing testing services across multiple U.S. states. Job Responsibilities: Laboratory Leadership and Oversight Provide scientific, clinical, and regulatory oversight for all molecular diagnostic testing operations at NYGC. Ensure the laboratory operates in full compliance with CLIA, NYS CLEP, CAP, and other applicable regulatory standards. Maintain active oversight of laboratory operations through regular presence and engagement with laboratory staff. Assay Development and Validation Lead the development, validation, and implementation of next-generation sequencing (NGS)-based diagnostic assays for constitutional genetics and oncology. Review and approve validation protocols, validation summaries, and performance characteristics for all new and modified assays. Ensure validation of both FDA-approved/cleared platforms and laboratory-developed tests (LDTs) in accordance with regulatory standards. Quality Management and Compliance Oversee the laboratory Quality Management System (QMS) including QA/QC programs, instrument maintenance records, and performance monitoring. Direct implementation and management of proficiency testing programs for genetic and oncology assays. Ensure ongoing compliance to maintain: New York State certification (Genetic Testing; Molecular Oncology - Tumor and Cellular Markers) CAP accreditation CLIA certification Lead continuous quality improvement initiatives and participate in monthly quality assurance meetings. Oversee applications and maintenance of state laboratory licenses for laboratories providing testing services across multiple U.S. states. Participate in CLIA, CAP, and institutional working groups or committees as appropriate. Clinical Interpretation and Reporting Provide professional interpretation, review, and sign-out of molecular diagnostic test results. Ensure test reports meet clinical, regulatory, and laboratory standards. Serve as a resource for clinical consultation with ordering physicians and healthcare providers. Personnel Oversight Supervise laboratory personnel and ensure appropriate training, competency assessments, and continuing education. Ensure laboratory staffing and qualifications meet regulatory requirements. This person must maintain sufficient on-site presence to provide effective oversight of laboratory operations. They must also be available for personal, telephone, or electronic consultation with laboratory personnel and clients. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change. Position Requirements: MD or PhD in molecular biology, genetics, or a related field. Board certification in an appropriate specialty (e.g., Clinical Molecular Genetics and Genomics or Molecular Genetic Pathology). Possession of New York State Certificate of Qualification (CQ) in Genetic Testing required. Additional NYS Certificates of Qualification (e.g., oncology, infectious disease) preferred. Minimum 5 years of leadership experience in a molecular diagnostics laboratory, including oversight of clinical NGS testing and laboratory personnel. Demonstrated expertise in molecular diagnostics assay validation, regulatory compliance, and quality systems. Experience directing laboratories performing constitutional genetic testing and molecular oncology testing preferred. Experience managing laboratories licensed in multiple U.S. states preferred. Don't meet every single requirement? At NYGC we are dedicated to building a diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right candidate for this or other roles. Competencies Technical and Professional Skills: Consistently demonstrates skills and knowledge relevant for current role; strives to expand the depth and breadth of technical and professional skills; works with a high level of integrity; exhibits focus and discipline; appropriately prioritizes, manages expectations and delivers on commitments. Collaborative & Communicative: Models collaboration and teamwork; brings out the best in others; effectively works with all levels, internally and externally; respects and embraces diversity of perspective; communicates clearly and listens carefully; uses good judgment as to what to communicate and when to do so. Adaptable & Innovative: Adaptable and embraces change; develops new insights and pursues improvements and efficiency; fosters exchange of new ideas and willing to challenge the status quo; takes initiative and is solution-oriented; engages in work with passion and curiosity. Leader and Manager: Attracts, develops and retains diverse talent to achieve outstanding results; encourages professional development, coaches and regularly communicates expectations and feedback; aligns and inspires efforts toward our mission; translates organizational vision into action; responsibly utilizes NYGC's human and financial resources to ensure organizational and financial health; uses good judgment when making decisions; pushes boundaries and generates new ideas. Work Flexibility NYGC has established a flexible work policy to give employees and other staff more ability to balance their work, personal commitments, and commuting challenges. The incumbent in this position is eligible for a flexible work schedule or hybrid remote work arrangement with supervisory approval. It requires a minimum of two days per week onsite. Occasional evening and weekend work may be required. Salary & Benefits The pay range for this position is $300,000-320,000 per year; the base pay offered may vary depending on job-related knowledge, skills, and experience. In addition, NYGC offers a full range of medical, financial, and other benefits as well as generous time off. This includes Medical/Dental/Vision for employees & dependent(s); Vacation, Holidays, Sick, and Other Leave, including a paid winter break; a 401(k) match; Life Insurance; Flexible Spending Accounts; employee Tuition Reimbursement; flexible schedules and telework options for some positions; an Employee Assistance Program; and much more. About the New York Genome Center The New York Genome Center (NYGC) is an independent, nonprofit, academic research organization dedicated to advancing genomic research. NYGC scientists and staff are furthering new approaches to diagnosing and treating neurological diseases and cancer through their unique capabilities in whole genome sequencing, RNA sequencing, state-of-the art analytics, and the development of genomic tools. NYGC concentrates specifically on disease-based research in the following areas: neuropsychiatric disease (autism, schizophrenia, bipolar); neurodegenerative disease (ALS, Alzheimer's, Parkinson's, Huntington's), and cancer. Located in Lower Manhattan, the New York Genome Center was founded by and remains closely affiliated with the leading academic medical centers and research universities in the New York region, engaging in research projects with and for these institutions. Essential to our collaborative work is an outstanding faculty, whose members typically hold a joint appointment at NYGC and a partner university. They support our scientific mission by conducting independent research in areas of mutual interest to us and the wider scientific community. Equal Opportunity We are committed to fostering a workplace environment that is welcoming and fair to all, ensuring that every employee has the opportunity to thrive. We believe that bringing together individuals with diverse backgrounds, experiences, and perspectives leads to greater collaboration, innovation, and discovery. Valuing and supporting each employee in reaching their full potential strengthens our organization and enhances our collective success. We recognize that creating an environment where all employees feel valued and included requires sustained effort and dedication from the entire organization. The New York Genome Center is a VEVRAA Federal Contractor. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, creed, color, gender, religion, national origin, sexual orientation, age, disability, genetic predisposition or carrier status, protected veteran or military status, domestic violence victim status, partnership status, caregiver status, alienage or citizenship status, marital status, or any other characteristic protected by applicable law. NYGC takes affirmative action in support of its policy to hire and advance in employment individuals who are protected veterans and individuals with disabilities. FLSA Status - Exempt This position is eligible for visa sponsorship and relocation assistance

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Program Lead, Digital Informatics QMS Strategy. This Program Lead is responsible for developing, maintaining, and communicating QuidelOrtho' s Quality Management System strategy for Digital Informatics, Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), and Automation platforms as they pertain to in vitro diagnostic (IVD) products and associated services across all global markets. This role serves as the strategic quality authority for digitalenabled products, ensuring that regulatory, quality, and compliance expectations are proactively embedded into product lifecycle processes, digital delivery models, and organizational ways of working. This position will be onsite in Rochester, NY. Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/MLenabled systems, cloudbased platforms, and automated workflows. Interpret and operationalize global regulatory and standards requirements (e.g., FDA, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, GxP data integrity) as they apply to digital and informatics solutions. Partner with R&D, IT, Product Management, Regulatory Affairs, PMO, and Technical Quality to ensure quality by design is embedded throughout the digital product lifecycle. Establish governance models, procedural frameworks, and decision pathways that enable agile and scalable digital innovation while maintaining regulatory compliance. Lead riskbased approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring. Serve as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, realworld data, automation, and digital transformation. Perform other work-related duties as assigned. Required: Bachelors and/or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering or a related technical discipline. 8-10 years of progressively responsible experience within a regulated Quality Management System environment, with significant exposure to software, digital health, or informatics solutions. Demonstrated ability to lead QMS strategy development and influence senior stakeholders across complex, matrixed organizations. Strong understanding of global regulatory frameworks applicable to digital health, SaMD, AI/ML, and automated systems. Proven experience applying risk management, design controls, software lifecycle processes, and post market surveillance to digital products. Ability to translate regulatory and quality requirements into practical, scalable processes that support innovation. Bias toward action, with a track record of driving execution aligned to organizational strategy. Excellent written and verbal communication skills, including the ability to represent quality positions to executive leadership. Strong collaboration skills and the ability to operate effectively across technical, regulatory, and business functions. Willingness and ability to travel approximately 10-15%. Preferred: Advanced degree (MS, PhD, or PharmD) strongly preferred. Experience with AI/ML governance, algorithm change management, or real-world performance monitoring. Background in cloudbased systems, cybersecurity, data integrity, or regulated automation platforms. Experience supporting global regulatory inspections involving software or digital health products. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. No strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: Thrive Together - Collaborate intentionally, grow as a team Make It Happen - Focus on priorities, embrace continuous improvement Commit to Service - Cultivate a service mindset Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $155,000 to $202,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-SP1

The Director, Medical Affairs (Nutrition) is responsible for leading and managing medical affairs for approved nutrition products and those in development. Areas of support include Product pre-launch and launch activities, Product Development, Product Lifecycle management, Business Development, and Post-Marketing medical affairs strategies. Collaborates cross-functionally and globally to ensure corporate goals and objectives are met at the highest levels. Directs the Region's medical needs for support of drugs and devices on the market, in development, and under evaluation. Responsible for cultivating and maintaining external relationships esp. with Health Care Providers (HCPs) and/or Health Care Decision Makers (HCDMs) to enable comprehensive scientific exchange around disease states and associated Company products. Must maintain scientific expertise in the application of treatment guidelines and clinical data as it pertains to disease states and associated Company products. Must be able to communicate complex medical and scientific concepts to a broad range of audiences. The Director, Medical Affairs, will also support execution of Medical Affairs strategy and activities where and as appropriate. The Director, Medical Affairs will lead the field clinical education team and ensure that the respective territory engagement plans are effectively executed per defined targets, following Fresenius Kabi compliance rules and code of conduct and that relevant medical and scientific insight is routinely shared to optimize the Medical Affairs strategy for the nutrition portfolio. *Priority will be given to candidates in the Chicagoland area who are able to regularly work at our Lake Zurich, IL site. *This position does not offer visa sponsorship either now or in the future. • Salary Range: $185,000-220,000., • Position is eligible to participate in an annual bonus plan with a target of 16% of the base salary., • Position is eligible to participate in our medium-term incentive plan., • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities., • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage., • Lead the strategic planning, launch, and lifecycle support of nutrition products including high-risk medications., • Lead the development and execution of medical affairs strategy to support successful product launch ensuring alignment with commercial, clinical development, regulatory teams and internal stakeholders., • Maintain the highest levels of professional integrity & performance standards by consistently providing high quality medical deliverables on time. Maintains a high standard for medical and scientific accuracy, representative of a comprehensive understanding of the medical concept at hand. Maintains a high level of professional expertise by staying abreast of current medical landscape with regard to key clinical conditions our products support., • Identify, engage, and build strong relationships with Key Opinion Leaders (KOLs), influencers in HCP community, scientific experts, and medical societies to support scientific exchange and advocacy., • Lead the nutrition team ensuring achievement of compliant and effective healthcare professional interaction for scientific exchange related to disease states and/or associated Company products per predefined engagement plans and targets., • Establish and maintain relationships with HCPs and HCDMs to provide scientific exchange related to disease states and/or associated Company products., • Represent the company at major medical and scientific conferences; manage planning and coordination of congress activities, including symposia, medical affairs booth presence, and thought leader engagements., • Oversee publication planning and execution, including abstracts, posters, manuscripts, and scientific communications, ensuring timely and compliant dissemination of clinical data., • Drive medical education initiatives for internal and external stakeholders, including training programs, advisory boards, and peer-to-peer education aligned with the product's scientific platform., • Provide scientific leadership and oversight for Investigator-Initiated Trials (IITs), including review, approval, and ongoing collaboration with investigators., • Collaborate cross-functionally to design and implement company-sponsored clinical studies to support product differentiation, real-world evidence generation, cost-effectiveness analysis, HEOR studies and post-marketing commitments., • Lead and manage a team of medical affairs professionals; provide coaching, development, and performance management to ensure high team effectiveness., • Collaborate with Global Medical Affairs in the support of USA-based clinical trials, both internal and external., • Review, develop, and approve clinical summaries in support of NDA 505(b)(2), ANDA, NDA applications., • Serve as a medical expert for on market parenteral nutrition products, products in development, and potential acquisition targets providing medical affairs strategies and due diligence for on market products and business development opportunities., • Responsible for writing and/or review of relevant Standard Operating Procedures (SOPs) pertaining to the role as needed. Job Requirements: • Medical/clinical professional degree required, such as Licensed Registered Dietitian., • Clinical Nutrition knowledge is required., • 10+ years of experience in the pharmaceutical industry in a medical affairs or clinical development role required., • 3+ years of hands-on experience in patient care and in hospital and/or clinic and/or home infusion settings is required, with demonstrated expertise in clinical nutrition including experience in managing formula selection for oral nutritional supplement use and tube feeding regimens., • 5+ years of clinical experience preferred., • 5+ years of direct people management experience with demonstrated ability to develop and lead high-performing teams., • Ability to understand and interpret the regulatory requirements under which drugs and devices are developed, reviewed, and supported after approval., • Experience with the clinical drug development process and product launch experience is highly preferred., • Scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents., • Position will require travel (20-50%), including overnight stays. A valid US driver's license and clean driving record are required., • Ability to understand and interpret FDA 505(b)2, 505(b)1, 505 (j) submission requirements., • Knowledge of PC systems and Microsoft Office Suite (Word, Excel) is required. We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Description: We believe in bold ideas, diverse perspectives, and the drive to transform knowledge into impact. Here, your curiosity fuels progress, your voice shapes innovation, and your ambition helps redefine what's possible within science and learning. We are a culture that obsesses over impact, challenges, and drives what's next to power infinite possibilities for our customers, colleagues and society at large. About the Role: We are looking for a Principal Scientist to be the senior scientific voice across Wiley's Clinical Outcome Assessment (COA) work, part of our AI and Data Analytics organisation. The role exists to make sure that the science underpinning every instrument we work with is sound, current, and well-represented, and that decisions across our business reflect the views of clinical authors and instrument developers. The role works closely with the medical societies and academic authors who originated these instruments, supports their continued scientific development, and represents Wiley credibly in the clinical outcomes community. It is an opportunity to do real scientific work alongside commercial, product, partnership, and publishing colleagues, and reports to the Senior Director, Clinical Outcome Assessments. Job Responsibilities • Provide expert scientific assessment of instruments across the portfolio, evaluating psychometric properties, validation evidence, and regulatory precedent in line with current measurement science., • Work closely with the medical societies, instrument authors, and academic groups behind the instruments in our portfolio, supporting their scientific work and acting as a senior point of contact for scientific questions., • Support the continued scientific development of instruments alongside their authors and Scientific Affairs colleagues, including evidence updates, validation work, and considered translation and adaptation programmes., • Provide scientific guidance to colleagues across the business so that customer conversations, product builds, and partnership decisions all reflect sound clinical measurement principles., • Represent Wiley as an active and credible participant in the clinical outcomes community, including at ISOQOL, ISPOR, CPATH, and other professional forums., • Provide scientific input to clinical platform product development, ensuring the platforms are built on sound clinical foundations and respect the integrity of the underlying instruments. Required Qualifications • Postgraduate degree (MSc, PhD, or equivalent) in clinical outcomes research, psychometrics, health economics and outcomes research (HEOR), epidemiology, clinical psychology, or a closely related discipline. Strong academic background combined with substantial practical experience in clinical measurement science is also acceptable., • 5+ years working with Clinical Outcome Assessments in a scientific, regulatory, or commercial context, including roles in pharmaceutical clinical development, CRO scientific affairs, health outcomes consultancy, academic research in psychometrics or patient-reported outcomes, or regulatory science., • Demonstrated ability to evaluate the psychometric properties and clinical utility of measurement instruments., • Familiarity with the regulatory landscape for COAs, including FDA Patient-Focused Drug Development guidance, EMA qualification, and ICH standards., • Strong literature review and evidence synthesis skills., • Familiarity with psychometric validation methodologies (classical test theory, item response theory, Rasch analysis)., • Ability to communicate complex scientific and psychometric concepts to both technical and non-technical audiences, with credibility among clinical and academic peers. Preferred Qualifications • PhD in psychometrics, HEOR, or clinical outcomes research., • Published research in COA-related fields., • Experience working across multiple therapeutic areas., • Track record of contributing to instrument development, validation, or regulatory submission, ideally in collaboration with academic or society partners., • Experience with systematic evidence review or meta-analysis., • Familiarity with CDISC standards for COA data., • Active engagement with ISOQOL, ISPOR, CPATH, or equivalent professional communities., • Familiarity with electronic COA implementation and the impact of mode of administration on measurement properties., • Knowledge of AI-assisted evidence synthesis approaches. We power infinite possibilities. For more than 200 years, we've transformed knowledge into discoveries that shape the world. Today, our global team of innovators, creators, and experts is driving what's next in science, education, and publishing-creating impact that reaches everywhere. We're not just observers of progress. We're the ones accelerating scientific breakthroughs, advancing learning, and sparking innovation that redefines entire fields and improves lives. Here, your talent matters. Your ideas have room to grow. And your work creates breakthroughs that can change everything. Wiley is an equal opportunity/affirmative action employer. We evaluate all qualified applicants and treat all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, protected veteran status, genetic information, or based on any individual's status in any group or class protected by applicable federal, state or local laws. Wiley is also committed to providing reasonable accommodation to applicants and employees with disabilities. Applicants who require accommodation to participate in the job application process may contact tasupport@wiley.com for assistance. We are proud that our workplace promotes continual learning and internal mobility. Our values support courageous teammates, needle movers, and learning champions all while striving to support the health and well-being of all employees. We offer meeting-free Friday afternoons allowing more time for heads down work and professional development, and through a robust body of employee programing we facilitate a wide range of opportunities to foster community, learn, and grow. We are committed to fair, transparent pay, and we strive to provide competitive compensation in addition to a comprehensive benefits package. The range below represents Wiley's good faith and reasonable estimate of the base pay for this role at the time of posting roles either in the United Kingdom, Canada or USA. It is anticipated that most qualified candidates will fall within the range, however the ultimate salary offered for this role may be higher or lower and will be set based on a variety of non-discriminatory factors, including but not limited to, geographic location, skills, and competencies. When applying, please attach your resume/CV to be considered. Salary Range: 53,000 GBP to 75,867 GBP#LI-JG2 Job Posting Title: Principal Scientist, Clinical Outcomes Location: Oxford, GBR

Job Locations US Job ID 2026-2210 # of Openings 1 Category Legal/Board Office/Governance Founded in 1912, Girl Scouts of the USA (GSUSA) is the preeminent leadership development organization for girls and the leading authority on their healthy development. Millions of Girl Scout alums across the country and the world have gone on to achieve incredible things and make a tremendous impact in fields ranging from public policy, medicine, journalism, and athletics to international relations, science, technology, art, and entertainment. As a mission-driven organization, Girl Scouts of the USA champions girls as they explore their worlds, try new things, and develop the courage, confidence, and character to make the world a better place. From stargazing during a first overnight camping trip to building robots, navigating a rocky hiking trail, working together on a community project, and learning about the importance of environmental stewardship, Girl Scouts of all backgrounds and abilities can unapologetically be themselves. As they rise to meet new challenges, they also discover the issues that matter most to them. Along the way, they learn the power of friendship, connection, and teamwork. Girl Scouts are doers, innovators, problem-solvers, creators, and dreamers, and the GSUSA team is here to center, support, and inspire them, working with 111 local councils across the country and USA Girl Scouts Overseas to deliver our life-changing Girl Scout Leadership Experience. The Office of the General Counsel handles all legal and compliance matters, litigation oversight, contract administration, intellectual property maintenance and enforcement, risk assessment, insurance portfolio management, corporate governance, and the administration of the Office of the National Board. #LI-REMOTE We are seeking an experienced, highly independent individual to join the Office of the General Counsel as a Vice President, Associate General Counsel. This person will provide legal expertise for Girl Scout Cookies' supply chain and E-commerce operations, negotiate key commercial agreements, advise on regulatory and operational matters, and mitigate legal and commercial risks. Manage commercial disputes and litigation; direct outside counsel and ensure efficient resolution. This role partners closely with business leaders to support transformational initiatives, oversee outside counsel, ensure legal documents reflect best practices, and strengthen collaboration across supply chain, retail, and E-commerce teams. Lead and independently negotiate, draft, execute and close critical commercial projects that support Girl Scout Cookies and its complex supply chain, including vendor, supplier, logistics, shipping, distribution, payment processors/providers and E-commerce/retail operations • Advise on supply chain operations, compliance, regulatory requirements, and supplier relationships, • Provide subject matter guidance to all levels of the business on operational and strategic decisions, work with leadership on transformational transactional objectives, • Provide practical, business-oriented legal advice and counsel to identify, assess, and mitigate legal and commercial risks as needed, • Reviewing and monitoring regulatory development around food/regulatory law and E-commerce compliance, consumer protections regulations, omni and website channel experiences, • Work with Girl Scout Cookie and Retail/E-commerce team to enhance collaboration among business team, compliance, and innovation teams., • Responsible for managing and overseeing outside counsel in connection with related matters., • Ensure that standard legal documents are updated from time to time to reflect best practices and provide expert guidance. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Extensive experience in drafting and negotiating commercial agreements and related documents customary in supply chain and procurement transactions, including transactional, vendor, supplier, logistics, distribution, and services agreements from start to finish with limited supervision., • Displays excellent written and verbal communication skills., • Experience analyzing, interpreting, and clearly communicating legal strategies and requirements to/for non-lawyer colleagues., • Strong understanding of legal risks in food-related operations and contracting and retail law experience., • Ability to integrate and balance priorities for the benefit of multiple internal clients., • Ability to understand key drivers of the supply chain function., • Ability to lead cross functional projects/teams to impact long-term legal strategies., • Ability to work independently, make decisions, and exercise independent judgment with respect to highly complex projects, contracts, and transactions in a fast-paced environment with tight deadlines., • Office 365 or similar suites, • Competency in PowerPoint or similar presentation software, • Competency in Microsoft Excel or similar software, • J.D. and active bar license (New York or other U.S. state of employment), • A minimum of 7 years of relevant experience in the practice of law having a combination of law firm and in house experience, • 5 plus years of experience in commercial contracting, procurement, supply-chain, or related industries including at least 2 years of CPG experience, including co-manufacturing agreements and labeling reviews, • Skilled in drafting/negotiating vendor/supplier agreements (preference for food experience), purchase orders, manufacturing/distribution contracts, NDAs, MSAs, service agreements, logistics/trade-compliance matters, risk assessment / mitigation, and coordinating with operations/procurement teams., • Preference for FDA regulatory experience, specifically in food labeling, ingredient statements, allergen disclosures, claims review, and compliance obligations applicable to packaged food. SALARY RANGE: $165,000 - $200,000 This represents the present low and high end of the pay range for this position. This pay range is only applicable to NYC Metro-based employees, on a hybrid schedule. Actual pay will vary based on various factors, including but not limited to experience. FEATURED BENEFITS: What We Offer: Girl Scouts is powered by people, and we encourage our team members to be their best selves in and out of the office. We place a high priority on flexibility and offer a competitive employee salary and benefits package that includes: Paid Time Off: GSUSA offers 20 days of paid time off, 2 floating holidays, as well as 9 workplace holidays per year. GSUSA staff also enjoy a paid holiday year-end office closure between Christmas and New Year's. Other Benefits: • Medical and Behavioral Health Coverage, • Plan options with individual and family coverage which includes wellness, hospitalization, and fertility assistance., • Both plans include GSUSA partial subsidy of premium costs, • Dental and vision coverage, • Health Savings Accounts (HSAs) and Flexible Spending Accounts (FSAs) including Health, Dependent Care, and Limited FSA for those with Health Savings Accounts, • Company-paid life insurance, • Flexible work arrangements, • 12 weeks of paid parental leave, • 401(K) with company match, • Short- and Long-Term Disability for salary continuation, • Health and Wellness Classes and Activities throughout the year WORK ENVIRONMENT: This is a remote position. POSITION TYPE / EXPECTED HOURS OF WORK: This is a remote, full-time position. Days of work are Monday through Friday. Occasional evening and weekend work may be required as job duties demand. AAP/EEO Statement: GSUSA is an equal employment opportunity employer. 0-10%

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manager of Regulatory Affairs. This role will manage and support a team of managers and employees of different levels. You will be responsible for developing and implementing local strategy and leading the day-to-day regulatory affairs on base business operations and new product development projects within the Transfusion Medicine Business Unit. This position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ; Rochester, NY; or Pompano Beach, FL Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. Interact with US FDA and/or EU Notified Body regulatory personnel (including Corporate International RA and/or country RA) to define submission content, expedite pending applications, and resolve regulatory matters. Responsible for the final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed. Make judgments about the operational impact of proposed actions, and identify, and interact with appropriate resources to successfully achieve company and regulatory strategy objectives. Reviews/ interprets product-specific regulatory issues that may have a material impact on the business, the corporation, or the customer; develop strategic and tactical responses to influence a reasonable and compliant regulatory environment. Represent QuidelOrtho to US and EU regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings for regulatory submissions. Identify and/ or lead process improvement projects to streamline current activities and increase department efficiencies. Development goals, such as webinars, reviewing FDA website and articles, reading journals, and attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs. Coach, mentor junior staff. Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risks and appropriate timing for approvals for planning purposes. Perform other work-related duties as assigned. Required: Bachelor's degree in a scientific or related discipline; or equivalent combination of education and experience. 10 years+ of experience in a regulated In Vitro Diagnostics and/ or Biologics Industry. 7+ years of experience developing and executing regulatory strategies for complex projects under product development or post-market changes requiring a US FDA submission (510(k), PMA and BLA or associated supplements and Annual Reports). Review and approval of product labeling and promotional and advertisement brochures and multimedia content. Coordinate and submit Pre-Sub meeting requests and associated regulatory strategic information and direct interaction with FDA product review branch(s). Previous people management experience. Excellent interpersonal, teamwork, and verbal/written communication skills. Good organizational skills and an ability to manage multiple tasks/projects/priorities. The ability to demonstrate model behavior and understand priorities and encourage others to drive for results will be needed. Ability to mentor and coach junior level staff as well as cross-train with peers. This position is not currently eligible for visa sponsorship. Preferred Direct experience with FDA CBER. Experience hosting or supporting Pre-Approval Inspections for either FDA, EU Notified Bodies or both. RAC (Regulatory Affairs Certification). Medical Device and/ or Pharmaceutical Industry experience is highly desirable. CE Mark under IVDD and current IVDR requirements, Canadian Licensing, and Rest of World (ROW) registrations is a plus. Use of Process Excellence (PEx) tools for process improvement initiatives. Internal Partners: Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality/Manufacturing Quality, Regulatory Affairs Managers/Directors, QO International and Regional Regulatory Affairs groups External Partners: Regulators in worldwide markets, for example TUV/BSI, FDA, Health Canada, etc. Third Party Contract Manufacturers and Suppliers. Use of a computer is required. Traditional office workspace or remote home office location. On occasion, may require up to 20% of domestic/international travel. The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $155,677.15 - $202,380.30 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-HF1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Director of Global Supply Network Excellence. The Quality & Compliance Director is a global people leader within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Quality professionals to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. This role provides strategic direction and operational oversight across QuidelOrtho' s overall supply network providing leadership for supplier quality and supply chain quality -ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). The role partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization, inspection readiness, and continuous improvement. The role leads the strategy for quality support of end-to-end supply chain. Encompassing distribution, marketing companies and supplier management. The responsibilities span all quality elements associated with the supplier management process including initial partner selection, creation and maintenance of quality agreements, monitoring of overall partner organization quality performance, supplier audit, change management and non-conformance / CAPA oversight. This position includes the oversight of the purchasing control processes. This role also demands identification and execution of continuous improvements to QuidelOrtho' s Supplier Quality Management processes at the global level to meet the current and future needs of the QuidelOrtho business. These improvements will ensure continued compliance with quality system regulations while driving overall efficiencies and improvements in QuidelOrtho' s Supplier Quality Management Processes. These initiatives will demand close collaboration with key stakeholders and business partners across the organization including but not limited to Global Procurement, Global Supply Chain, Operations, R&D, Site Quality, Design Quality, Global Compliance and Regulatory. This leader is also accountable for developing talent, strengthening scientific and compliance capabilities, and fostering a culture of engagement, collaboration, and performance. By integrating technical expertise, data-driven insights, and agile leadership behaviors, the Quality & Compliance Manager/Senior Manager ensures that Quality systems and teams deliver sustainable business and compliance outcomes. This position will be onsite in Rochester, NY or San Diego, CA. Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives. Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs. Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements. Management Responsibility as required by ISO13485/9001 and ensuring specific economic operator roles are fulfilled - for example, importer / distributor / Authorized Representative responsibilities Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency. Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle. Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS). Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits. Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements. Coach and mentor emerging Quality leaders and technical experts to build organizational capability and ensure robust succession planning. Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders. Manage departmental budget and resources effectively, identifying opportunities to drive cost efficiencies while maintaining compliance and quality standards. Model QuidelOrtho' s leadership principles by demonstrating collaboration, accountability, inclusion, and service mindset in all interactions. Person Responsible for Regulatory Compliance (PRRC per EU IVDR (2017/746) on behalf of the wholly-owned legal manufacturers of QuidelOrtho Corporation as defined in the Delegation of Authority (DMS-POL80064) Article 15(3)(a): Responsible for ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. Execution of Importer and distributor responsibilities, specially making sure that the devices placed on the market bear the CE marking, are accompanied by the required information and labelled in accordance with the Regulation, and storage and transport conditions are in line with specifications. Perform other work-related duties as assigned. Required: Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required.12+ years' experience in Medical Device quality system management Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR Experience/knowledge of Supplier Quality Management Processes, auditing, Change Management, Root Cause Analyses, Corrective/Preventive Actions Experience/knowledge with distribution processes, logistics and supply chain operations Proven ability to lead and develop high-performing teams and build future technical and people leaders. Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations. Excellent collaboration, influence, and communication skills across functional and organizational boundaries. Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement. Experience leading in a matrixed, global organization and managing competing priorities effectively. Commitment to scientific integrity, compliance excellence, and continuous improvement Preferred: Desirable certifications include ASQ -CQA, ASQ-CQE, ASQ-SWQE, ASQ-CQM, Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline. Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools. Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, and other Quality & Compliance teams globally and regionally External: Suppliers/External Manufacturers: In line with established Quality Agreements ensure partnership with External Partner sites to monitor and improve quality performance The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: Thrive Together - Collaborate intentionally, grow as a team Make It Happen - Focus on priorities, embrace continuous improvement Commit to Service - Cultivate a service mindset Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $155,000 to $249,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-SP1

The Enterprise Account Executive (Healthcare & Life Sciences) will report to the Director of Enterprise GTM and own revenue growth across a portfolio of Scale AI's most strategic healthcare and life sciences customers. This role is focused on selling complex, agentic AI solutions - autonomous workflows powered by LLMs and human-in-the-loop systems - into health systems, payers, pharma, biotech, and digital health organizations. You will act as a strategic partner to clinical, operational, and technical leaders - helping them transform core workflows such as clinical documentation, prior authorization, revenue cycle, pharmacovigilance, clinical trials, medical affairs, and patient engagement through AI agents. This is a highly consultative, technical enterprise sales role requiring deep domain fluency, strong executive presence, and the ability to navigate regulatory, compliance, and multi-stakeholder complexity. You will own the full customer lifecycle - from origination through close, deployment, and expansion - while quarterbacking cross-functional teams across Solutions Engineering, Product, Research, and Delivery to land and scale high-impact AI programs. • Own and expand relationships with leading healthcare and life sciences organizations (providers, payers, pharma, biotech), focusing on multi-year, strategic AI initiatives, • Sell agentic AI solutions by mapping Scale's capabilities to high-impact workflows (e.g., clinical documentation, prior auth, revenue cycle, patient ops, clinical trials, drug safety, medical review), • Build trusted relationships with executive stakeholders (CIO, CTO, CMIO, Chief Data/AI Officer, Heads of Clinical Ops, R&D, Commercial), • Develop and execute multi-threaded account strategies that drive net-new revenue, expansion, and long-term platform adoption, • Lead complex deal cycles, including ROI modeling, business case development, and mutual close plans across new business, renewals, and expansions, • Partner closely with Solutions Engineering to design and land technically credible pilots, POVs, and production deployments, • Navigate healthcare-specific regulatory and compliance requirements (e.g., HIPAA, GxP, data governance, auditability) throughout the sales process, • Act as the voice of the customer internally - informing product roadmap, agent design, and vertical-specific solutions, • Maintain strong pipeline discipline, forecasting accuracy, and deal hygiene using Salesforce, Clari, and related tools, • Operate effectively in a fast-paced, cross-functional environment with high ownership and attention to detail, • 8-12+ years of enterprise sales experience, with significant focus on healthcare or life sciences (providers, payers, pharma, biotech, or digital health), • Proven track record of closing and expanding large, complex, multi-million dollar deals in regulated environments, • Experience selling AI/ML, data platforms, or workflow automation technologies, with the ability to position agentic / LLM-driven solutions to both technical and non-technical stakeholders, • Strong understanding of key healthcare/life sciences workflows (e.g., clinical operations, revenue cycle, patient engagement, R&D, clinical trials, pharmacovigilance), • Demonstrated success engaging executive stakeholders and building compelling ROI-driven business cases, • Familiarity with regulatory and compliance considerations (e.g., HIPAA, FDA/GxP, data privacy, model governance), • Strong command of enterprise sales fundamentals, including account planning, multi-threading, and forecasting discipline, • Ability to navigate long, complex sales cycles with multiple stakeholders and competing priorities, • Excellent communication, storytelling, and executive presence, • High degree of ownership, intellectual curiosity, and a consultative, customer-first mindset, • Experience selling agentic AI, LLM platforms, or automation solutions into healthcare or life sciences, • Background working with clinical, regulatory, or data organizations, • Familiarity with EHR systems, clinical data, or real-world evidence platforms, • Experience in high-growth or emerging technology environments Compensation packages at Scale for eligible roles include base salary, equity, and benefits. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position and may be inclusive of several career levels at Scale; it will be determined during the interview process based on work location and additional factors, including job-related skills, experience, qualifications, interview performance, and relevant education or training. Scale employees in eligible roles are also granted equity based compensation, subject to Board of Director approval. Your recruiter can share more about the specific salary range for your preferred location during the hiring process, and confirm whether the hired role will be eligible for equity grant. You'll also receive benefits including, but not limited to: comprehensive health, dental and vision coverage, retirement benefits, a learning and development stipend, and generous PTO. Additionally, this role may be eligible for additional benefits such as a commuter stipend. Please reference the job posting's subtitle for where this position will be located. For pay transparency purposes, the base salary range for this full-time position in the locations of San Francisco, New York, Seattle is:$200,000—$230,000 USD PLEASE NOTE:Our policy requires a 90-day waiting period before reconsidering candidates for the same role. This allows us to ensure a fair and thorough evaluation of all applicants. About Us: At Scale, our mission is to develop reliable AI systems for the world's most important decisions. Our products provide the high-quality data and full-stack technologies that power the world's leading models, and help enterprises and governments build, deploy, and oversee AI applications that deliver real impact. We work closely with industry leaders like Meta, Ernst & Young, Mayo Clinic, Time Inc., the Government of Qatar, and U.S. government agencies including the Army and Air Force. We are expanding our team to accelerate the development of AI applications. We believe that everyone should be able to bring their whole selves to work, which is why we are proud to be an inclusive and equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability status, gender identity or Veteran status. We are committed to working with and providing reasonable accommodations to applicants with physical and mental disabilities. If you need assistance and/or a reasonable accommodation in the application or recruiting process due to a disability, please contact us at accommodations@scale.com. Please see the United States Department of Labor's _ for additional information. We comply with the United States Department of Labor's Pay Transparency provision. PLEASE NOTE: We collect, retain and use personal data for our professional business purposes, including notifying you of job opportunities that may be of interest and sharing with our affiliates. We limit the personal data we collect to that which we believe is appropriate and necessary to manage applicants' needs, provide our services, and comply with applicable laws. Any information we collect in connection with your application will be treated in accordance with our internal policies and programs designed to protect personal data. Please see our _ for additional information.

AML/BSA program evaluation) - Provide structured feedback on AI accuracy in areas such as regulatory standards (FINRA, OCC, FFIEC, FDA, SEC, GDPR, HIPAA), risk frameworks (COSO, ISO 31000), and industry-specific compliance terminology - Collaborate asynchronously with research teams to refine evalua

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice is searching for a Principal Clinical Data Scientist Consultant – R Programmer to join one of our clients. We are seeking a Clinical R programmer / Principal Clinical Data Scientist to join our Scientific Computing Technology group, which builds the open-source tools, R packages, SAS macros, and computing systems that power clinical programming, data management, and biostatistics across the organization. Reporting to the Director of Statistical Programming, this role blends hands-on clinical deliverables with contributions to the open-source and internal tooling that supports the wider clinical technical community. The ideal candidate has strong R skills, deep clinical programming experience, working Python familiarity, and an interest in modern, reproducible workflows. This position is open to remote candidates. • Develop, validate, and maintain SDTM and ADaM datasets in R — using admiral and the broader pharmaverse — following CDISC standards., • Generate Tables, Listings, and Figures (TLFs) in R or SAS as required by study needs., • Perform Pinnacle21 validation, resolve findings, and refine specifications to ensure CDISC compliance and submission readiness., • Write efficient, reproducible, well-structured R code for clinical data analysis and reporting., • Contribute to open-source and internal tooling — including R Shiny / teal modules, R packages, SAS macros, and Python utilities — used by clinical programming, data management, and biostatistics teams., • Partner with statisticians, data managers, and clinical teams to translate programming requirements into reliable deliverables., • Perform QC, reconcile data issues, and ensure outputs meet regulatory expectations (e.g., FDA, EMA)., • Support automation, pipeline development, and version-controlled workflows., • Use SAS for legacy studies or where SAS support is needed., • Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field., • 5+ years in clinical programming, with a strong focus on R., • Proven experience producing SDTM and ADaM datasets in R, including hands-on use of admiral., • Experience with Pinnacle21 validation and remediation., • Working knowledge of SAS programming., • Working knowledge of Python for analytics, scripting, or tooling., • Solid understanding of CDISC standards (SDTM, ADaM) and metadata-driven programming., • Experience with clinical trial data, regulatory submissions, and QC processes., • Strong analytical, problem-solving, and documentation skills., • Broader pharmaverse experience (e.g., tidyCDISC, rtables) and tidyverse fluency., • Experience building or contributing to R Shiny apps, teal modules, or R packages used by other teams., • Exposure to AI/ML tooling in a clinical or programming context., • Real-World Evidence (RWE) experience — e.g., mapping Flatiron or claims/EHR data into CDISC-aligned structures., • R Markdown, Quarto, or other reproducible reporting workflows., • GxP validation, Git-based version control, and CI/CD or automated workflows., • CRO or pharmaceutical industry experience. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our low industry-average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-#TT1 #LI-Remote #Principal#Contract

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit _. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. Director Statistical Programmer The Director Statistical Programing (SP) reports to the SVP, Biometrics and is accountable for the production of SDTM and ADAM datasets and Tables, Listings, and Graph output (TFLs) for clinical studies. They will collaborate with partner functions in the Clinical Development Department (e.g. Clinical Operations, Clinical Research, Biostatisticians). They will be accountable for Medical Affairs support by providing output for posters, presentations, and publications. Key Responsibilities: • Accountable for all core SP deliverables (SDTM, ADAM, TFLs), • May also be accountable for clinical programming tasks (creation of SDTM and complex edit checks), • Provides ongoing data review by providing programmed edit checks, risk-based monitoring metrics, and draft TFLs, • With IT, defines our programming environment and its validation, • Responsible for the development of standards, SOPs, and best practices, • The role is a combination of vendor oversight, supervision of more junior statistical programmers, and some hands-on work., • The Director SP will supervise assigned junior programmers, both contractors and regular staff members. Qualifications • BS/BA degree and 10+ years of experience in analyzing clinical data OR, • MS in statistics or related area and 7+ years of experience in analyzing clinical data., • Experience with FDA submissions and the provision of data submission packages, • Experience in multiple areas outside of clinical development (e.g. pre-clinical, medical affairs, RWE), • Deep knowledge of the SAS programming language, • Demonstrated accomplishments in automatization (usually through SAS macro development), • Working knowledge of at least one other programming language, preferably R, • Experience with using genAI to create programming code or data processing algorithms., • Ability to work in an interdisciplinary team in a collaborative way, • Represents biometrics in a positive and professional manner, • Ability to work in a fast-paced team environment with fluctuating priorities, • Common sense and solution-oriented mindset, • Intellectual curiosity with a sense of pragmatic implementation of new ideas, • Ability to communicate effectively in English, both orally and in writing. Core Competencies • Strong understanding of clinical development processes and regulatory expectations, • Ability to lead and influence in a matrixed environment, • Demonstrated ability to balance urgency with quality, • Analytical rigor with a pragmatic, execution-oriented mindset Travel • This position requires up to 10% travel. Frequently travel is outside the local area and overnight. This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level. US Salary Range: $235,000 - $248,000 #LI-Remote

We’re partnering with a rapidly growing global technology innovator that’s applying its expertise in precision automation, and vision systems to revolutionize neurosurgical robotics. The company’s FDA-cleared, navigated cranial robotic system is entering full commercialization across U.S. and international markets. The Global Product Manager will define and drive global product strategy for a next-generation neurosurgical robot used in deep brain stimulation, biopsy, and other minimally invasive cranial procedures. This role serves as the critical bridge between engineering, marketing, and clinical users — ensuring commercial success and product evolution across multiple regions. Please note: Relocation to San Diego is required within 12 months of hire. • Global Product Strategy: Develop and execute the global product roadmap, positioning, and launch strategy to drive adoption and market penetration., • Voice of Customer (VOC): Lead clinical and market research to capture insights from neurosurgeons, hospitals, and distributors; translate those into actionable product requirements., • Lifecycle Management: Oversee the product throughout its lifecycle, from concept through obsolescence — including enhancements, upgrades, and integration opportunities., • Market Development: Partner with regional sales and marketing teams to identify new indications, segments, and geographic expansion opportunities., • Competitive Intelligence: Monitor neurosurgical robotics, navigation, and image-guided surgery trends; deliver regular market insights to leadership., • Cross-Functional Collaboration: Work closely with R&D, regulatory, clinical, and operations teams to align development and commercialization priorities., • Commercial Enablement: Create sales tools, clinical value messaging, and training content to support global product launches., • KOL Engagement: Partner with leading neurosurgeons to advance validation studies, reference site development, and ongoing clinical feedback., • 7+ years of product management or marketing experience in the medical device industry, ideally within robotics, surgical navigation, neurosurgery, or capital equipment., • Proven success managing products through launch and global commercialization., • Background in engineering, biomedical sciences, or clinical applications preferred., • Strong understanding of hospital capital sales cycles, as well as regulatory and reimbursement dynamics., • Experience collaborating across international markets and cross-functional teams., • Exceptional communication, presentation, and stakeholder-management skills., • Bachelor’s degree required; MBA or advanced technical degree preferred.

At Weave, our mission is to evolve how therapeutic knowledge is captured, transformed, and communicated throughout drug development. We do this by equipping human experts with AI instruments to enable drugs to be brought to patients as rapidly, safely, and inexpensively as possible. The Weave Platform streamlines regulatory workflows from start to finish by intelligently, creatively, and effectively infusing every step with AI. Together with our customers, Weave is designing and building the AI workbench for the entire therapeutic lifecycle. We are seeking a Customer Success Manager, reporting to our Director of Customer Success. This is a unique and pivotal role that requires a person of expertise and intent in change management. You will leverage your deep experience with relationship building and AI implementation to enable our customers to get the most out of the Weave, our AI-driven SaaS platform for FDA document preparation. Your experience and judgement will help our customers close the gap between the state of the product on any given day and their successful submissions. In practice, you embody a consultant, an expert user, and a guide- thoughtfully navigating our customers’ prioritization across learning & enablement and transition of systems & processes, while owning tactical facilitation of our shared goals to enable evaluation & access to therapies. • Onboarding and Training: You will devise and maintain an onboarding and training plan for new organizations and new users, including documentation and interactive sessions. You will provide the training, virtually and in-person (up to 50% travel, likely less)., • Platform Customization: With the support of the Product teams you will devise and execute a process for customizing the platform for new customers. Primarily this entails customization of document templates for AI-generation of regulatory submission content, • Process and Systems: You will establish stage-appropriate processes and systems to ensure that Customer Success is consistent, efficient, and effective., • Account Advocacy: You will endeavor to ensure that our customers are getting as much value as possible from their use of Weave’s products, and that Weave’s products are reaching all users within our customer organizations who might benefit from them., • Commercial/Product Collaborator: As the closest person to our customers you will be a vital conduit for user understanding to improve our platform and products, and for account renewal and expansion to grow the business., • Experienced Meets Innovative: You’ve been around the block and know the first 10 things you need to do. But you’re not looking to run a playbook, you’ve got a pot of ideas simmering about many ways to make CS and customers’ experience better., • Bio Conversant: You can speak the language of drug development and, crucially, drug developers will speak to you. You don’t need a PhD, but PhD’s need to find you credible., • AI Capable + Pragmatic: You know your way around an LLM (as much as anyone can right now) but you don’t get lost in the weeds., • Outstanding Educator and Communicator: Educating isn’t a chore for you, it’s a joy. You love to see people “get it” and enjoy the craft of figuring out how to help them get there., • Builder: You relish uncharted territory and yearn to build a cabin in it (figuratively speaking)., • 5+ years experience in Customer Success in B2B SaaS strictly required, • Experience serving life science, bio, or therapeutics markets highly preferred, • Bio education preferred, advanced degree ideal 🎯 The opportunity to work at a modern, cutting-edge healthcare technology company devoted to meaningful positive impact on human life. Collaboration, velocity, and customer obsession are our baseline, demonstrations of craftsmanship and ROI are celebrated. 🏆 Competitive salary ($120,000 to $165,000) and retention-based variable compensation plus equity. 🧬 Comprehensive health, dental and vision insurance 🏝️ Take care of you and yours: generous PTO, parental leave, OneMedical, TalkSpace, Teladoc. 🚀 Career development opportunities within a company entering a growth phase. 🌎 This is a remote position based in Boston, MA. Equal Opportunity Employer: We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. This organization participates in e-Verify: _ _

Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles. Empowering the world starts with living _ and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office. We are seeking a Senior Product Manager – Heart Health to join our growing Health Sensing organization. Reporting to the Director of Product Management, Health Risk Detection, this role will focus on advancing Oura’s cardiovascular health experiences, from proactive monitoring to long-term heart health insights. You’ll join an established, cross-functional team dedicated to Heart Health. You’ll collaborate with Science, Design, Engineering, and Regulatory partners to accelerate our roadmap, deepen member value, and bring science-backed heart health features to life. This is a high-impact opportunity to help shape how millions of people understand and care for their cardiovascular health through wearable technology. • Partner closely with Science and Engineering teams to define and deliver next-generation heart health sensing and signal analysis capabilities, • Translate scientific findings and physiological concepts into intuitive, meaningful product experiences that empower members to better understand their heart health, • Support discovery and development of new features spanning both wellness and regulated use cases, • Contribute to the prioritization and delivery of roadmap initiatives, balancing scientific feasibility, user impact, and business opportunity, • Partner with Design to create user experiences that communicate complex heart health data with simplicity and empathy, • Collaborate with Regulatory, Legal, and Quality teams on product strategies that align with applicable regulatory frameworks, • Communicate progress, insights, and tradeoffs effectively to leadership and cross-functional stakeholders, • Contribute to the broader Health Risk Detection strategy and align heart health workstreams with Oura’s mission to empower proactive health ownership This is a remote US role with a preference for east coast time zone. Openness to flexible hours to support cross-time-zone collaboration with teams in Europe and the U.S. REQUIREMENTS We would love to have you on our team if you have: • 5+ years of product management experience, ideally in connected health, digital biomarkers, or wearable sensing., • Experience delivering products or research-based features in cardiovascular health, fitness, or related physiological domains., • Strong understanding of key cardiovascular signals (e.g., HRV, ECG, PPG, blood pressure estimation) and their application in consumer or regulated products., • Proven success translating early-stage scientific research into member-facing experiences., • Familiarity with the nuances between wellness and medical-grade products; experience with FDA or other regulatory processes is a plus., • Excellent collaboration and communication skills with scientists, engineers, designers, and clinicians., • A passion for helping people live longer, healthier lives through actionable, science-backed insights. BENEFITS At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health. What we offer: • Competitive salary and equity packages, • Health, dental, vision insurance, and mental health resources, • An Oura Ring of your own plus employee discounts for friends & family, • 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off, • Paid sick leave and parental leave Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates' pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future. • Region 1: $172,550 - $203,000, • Region 2 $158,950 - $187,000, • Region 3 $147,900 - $174,000 A recruiter can determine your zones/tiers based on your US location. We are not considering candidates residing in the following states: Alaska (AK), Arkansas (AR), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), Rhode Island (RI), South Dakota (SD), Vermont (VT), West Virginia (WV), and Wisconsin (WI). Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics. We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Disclaimer: Beware of fake job offers! We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note: • Our jobs are listed only on the ŌURA Careers page and trusted job boards., • We will never ask for personal information like ID or payment for equipment upfront., • Official offers are sent through Docusign after a verbal offer, not via text or email. Stay cautious and protect your personal details. To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.

About Brillio: Brillio is one of the fastest growing digital technology service providers and a partner of choice for many Fortune 1000 companies seeking to turn disruption into a competitive advantage through innovative digital adoption. Brillio, renowned for its world-class professionals, referred to as "Brillians", distinguishes itself through their capacity to seamlessly integrate cutting-edge digital and design thinking skills with an unwavering dedication to client satisfaction. Brillio takes pride in its status as an employer of choice, consistently attracting the most exceptional and talented individuals due to its unwavering emphasis on contemporary, groundbreaking technologies, and exclusive digital projects. Brillio's relentless commitment to providing an exceptional experience to its Brillians and nurturing their full potential consistently garners them the Great Place to Work® certification year after year. Consultant • CSPO Role: - Pharma Product Manager Location: - Remote JD:-Pharma domain Software Product Manager • We are seeking an experienced Software Product Manager to lead product strategy, discovery, and delivery for software solutions supporting pharma pre-clinical, clinical and manufacturing operations. The ideal candidate brings 8+ years of industry experience, including direct experience in pharma or in a product management role serving pharma, with a strong understanding of clinical trials or manufacturing processes, regulated environments, and enterprise platforms, operating at the intersection of technology, pharma operations, and compliance. You will help shape products that improve manufacturing efficiency, support regulatory readiness, and deliver measurable business value for life sciences organizations. Responsibilities • Define product strategy and roadmap for software products supporting pharma manufacturing and operations., • Lead end-to-end product development from concept through launch and continuous improvement., • Work closely with engineering, design, QA, operations, and business stakeholders to translate business needs into clear product requirements., • Gather, prioritize, author, and manage product requirements, user stories, and acceptance criteria., • Collaborate with geographically distributed cross-functional teams across time zones., • Ensure solutions align with pharma manufacturing workflows, compliance expectations, and enterprise system integrations (e.g. ERP, SCADA, LIMS)., • Partner with stakeholders to support product adoption, training, and release readiness., • Track product performance, gather feedback, and use data to guide roadmap decisions. Required Qualifications • 8+ years of overall industry experience., • Experience in pharma, life sciences, or a product management role supporting pharma-related solutions., • Strong knowledge of pharma manufacturing processes and operational workflows., • Familiarity with regulatory requirements, including FDA, EMA and MHRA regulations., • Experience working with or delivering products in the context of MES, LES, QMS, and CMMS, CTMS, IRT platforms., • Hands-on experience with product management tools such as Jira and Aha., • Proven ability to work effectively with distributed teams across multiple locations and functions., • Demonstrated experience building a product from scratch, from ideation to launch., • Strong communication, stakeholder management, and problem-solving skills. Preferred Qualifications • Experience delivering software in regulated environments leveraging AI capabilities., • Background in digital transformation, manufacturing systems, or enterprise SaaS., • Familiarity with cloud native software development, validation, audit readiness, and change control processes. Key Competencies • Product strategy and roadmap ownership., • Requirements gathering and prioritization., • Cross-functional leadership., • Regulatory and compliance awareness along with AI enablement., • Customer-centric thinking., • Execution in complex enterprise environments. $75 - $80 an hour Know more about Brillio : _ PPE: _ Equal Employment Opportunity Declaration Brillio is an equal opportunity employer to all, regardless of age, ancestry, colour, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation. #LI-PS1 Know what it’s like to work and grow at Brillio: _We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting-edge technologies that restore autonomy to people living with disabilities and improve their quality of life. Join a small, dedicated team of knowledgeable and motivated professionals. Our early-stage environment offers the opportunity to take ownership of broad decisions with significant and long-lasting impact. We emphasize continuous learning and growth, fostering cross-functional collaboration where your contributions are vital to our success. Position Overview As the Lead Electrical Test Engineer, you will be responsible for planning, coordinating, and executing system-level electronics testing that demonstrates Echo’s BCI devices are safe, effective, and compliant with FDA and international standards. You will lead electrical testing across Pre-V&V, V&V, and production, ensuring requirements are testable, designing rigorous test protocols, and delivering FDA-ready evidence for design controls. In addition to verification and validation, you will establish and maintain production test strategies to ensure reliable device manufacturing. With your expertise in electronic systems and test engineering, you will bridge development and operations to ensure Echo’s implantable and wearable systems meet the highest safety, quality, and manufacturability standards. Key Responsibilities Define and lead system-level test strategies across electrical subsystems, integrated device, and system validation. Translate system and design requirements into test protocols with clear, measurable acceptance criteria. Lead Pre-V&V electronics efforts: bench bring-up, early feasibility testing, and design-for-testability. Direct system-level verification and validation testing (bench, hardware-in-loop, simulated clinical use, IEC 60601 electrical safety). Develop and maintain production test systems: design test fixtures, sockets, automation scripts, and scalable processes for manufacturing. Collaborate with Electrical, Firmware, Systems, QA, and Regulatory teams to ensure compliance with FDA 21 CFR Part 820, ISO 14971 (risk management), and related standards. Liase with System DVT lead, internal teams, and consultants. Generate Verification and Validation Reports, production test documentation, and FDA submission-ready documentation. Lead failure investigations at system and production level, ensuring root cause analysis and corrective actions are documented and retested. Provide test engineering leadership in support of design transfer to manufacturing and ongoing production quality. Qualifications Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or related field. 7+ years of experience in electronics/system testing, verification, and validation for medical devices. Proven experience leading component-level, subsystem, and system-level test campaigns for Class II or III medical devices (implantable preferred). Experience in designing and scaling production test systems for medical electronics. Strong knowledge of standards and regulations: 21 CFR Part 820 (Design Controls) IEC 60601 (Electrical Safety & EMC) ISO 14971 (Risk Management) IEC 62366 (Usability Engineering) Familiarity with hardware-in-loop and system integration test methods. Experience collaborating across disciplines (EE, FW, ME, QA, RA, Manufacturing, external labs). Skills and Abilities Expertise in electronic system test methods: signal integrity, power analysis, EMI/EMC, environmental stress, and safety compliance. Ability to design, implement, and oversee system-level verification and validation test plans. Proven experience developing and maintaining production test setups, fixtures, and automation for medical device manufacturing. Proficiency with lab equipment: oscilloscopes, spectrum analyzers, DMMs, logic analyzers, power analyzers. Skilled in writing clear, defensible test protocols and reports for regulatory and manufacturing use. Strong organizational discipline in traceability, version control, and change management. Ability to lead cross-functional test campaigns and manage external test labs/CROs. Excellent communication skills, able to translate test results for engineers, QA/RA, and regulatory reviewers. An opportunity to work on exciting, cutting-edge projects to transform patients’ lives in a highly collaborative work environment. Competitive compensation, including stock options. Comprehensive benefits package. 401(k) program with matching contributions. Echo Neurotechnologies is an Equal Opportunity Employer (EOE). We celebrate diversity and are committed to creating an inclusive environment for all employees. All applications will be treated confidentially. Applicants may be asked to sign an NDA after the initial stages of the interview process.

General Summary Under the general supervision of a Statistics Project Manager or higher, the Senior Statistical Programmer Analyst prepares analysis programs to support the preparation and statistical analysis of clinical data, coordinates the statistical programming activities for multiple clinical projects, ensures internal consistency of output, and assesses consistency with other projects and activities. Specific Duties and Responsibilities -Following specifications, develops algorithms and writes programs to create datasets. * -Produces data listings, summary tables and graphs using analysis software. * -Independently checks data listings, summary tables and graphs. * -Imports and exports data. * -Assists data management group in performing data edit checks to facilitate data cleaning. -Maintains complete and in-depth understanding of all Clinical Data Interchange Standards Consortium (CDISC) guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. Keeps abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing. * -Prepares clinical trial datasets and programs for regulatory submission. -Following statistical analysis plan, writes specifications for analysis datasets. -Interacts with the project statistician and other programmers participating on a project team. -Manage the data warehouse used to manage libraries of clinical study data. -Interact with regulatory affairs, quality assurance staff, and external clinical system vendors. -Mentors less experienced statistical programmers. -Act as the subject matter expert on CDISC and good statistical programming practices. -Builds efficient SAS coding and macro libraries. -Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements. * -Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * -Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.* -Ensure other members of the department follow the QMS, regulations, standards, and procedures. * -Perform other work-related duties as assigned. *Indicates an essential function of the role Position Qualifications Minimum education and experience: -Bachelor’s degree in statistics, computer science, or similar quantitative field, with 5+ years statistical programming experience and 3+ years of experience in clinical statistical programming within medical device or a related industry (biotechnology, pharmaceutical, Clinical Research Organization (CRO)), or an equivalent combination of relevant education and applicable job experience may be considered Additional qualifications: -Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT -SAS Certified Base and/or Advance Programmer experience is preferred -Experience with macro programming and SAS/SQL a plus -Good communication skills and attention to detail are crucial -Proven ability to handle multiple tasks -Able to identify ways to improve business performance and campaigning for it when necessary -Knowledge of international regulations, requirements and guidance associated with clinical data standards and clinical databases used for regulatory submission -Knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define and controlled terminology -Experience with metadata repository in clinical data a plus -Experience with regulatory submissions a plus -Knowledge of clinical data management systems, e.g., Oracle InForm and/or RAVE -Expertise at using SAS in Data Import (extracting the raw data from data warehouse with SAS/ACCESS and performing data pre-processing for particular statistical analysis), Data Manipulation (using SAS data steps and PROCs to modify datasets and transform, generate, and process data with array, do loop, merge, PROC SQL, PROC SORT, PROC TRANSPOSE, etc.); Data Analysis (analyze data using PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC TTEST, PROC GLM, PROC LOGISTIC, PROC LIFETEST, PROC PHREG); Data Export: generate output with PROC REPORT, PROC SGPLOT, SAS/ODS; Graphs (Kaplan-Meier plot, box plot, bar chart, water-fall plot, forest plot, shift plot, life table, prevalence plot, etc.) -Proficient in developing SAS/MACROS to access, extract, modify, merge, and analyze clinical data Working Conditions -General office environment -Business travel from 0% - 10% -Requires some lifting and moving of up to 25 pounds -The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception Annual Base Salary Range: $140,000 - $191,000 This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. What We Offer•A collaborative teamwork environment where learning is constant, and performance is rewarded.•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws. If you reside in the State of California, please also refer to For additional information on Penumbra’s commitment to being an equal opportunity employer, please see