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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: 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 _.

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 _.

Inizio Engage has partnered with a pharmaceutical company to build a nationwide team of Clinical Educators. The program is educational support in the area of primarily psychiatry. The Clinical Educator will deliver educational support to identified Healthcare Professionals (HCP) within Mental Health settings of care. This is your opportunity to join Inizio Engage and represent a top biotechnology company! What’s in it for you? • Competitive compensation, • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions, • Employee discounts & exclusive promotions, • Recognition programs, contests, and company-wide awards, • Exceptional, collaborative culture, • Best Places to Work in BioPharma (2022, 2023, & 2024), • Certified Great Place to Work (2022, 2023, 2025) What will you be doing? • Provide product demonstration and education to Healthcare Professionals in a variety of offices and facilities within a defined geographic territory. To provide disease state related educational support to identified Healthcare Professionals and office staff as agreed with the Client Account Manager., • To present educational programs to Healthcare Professionals in accordance with the needs of each office., • To only use approved materials provided by Inizio Engage or by the client, without changing, copying or distributing the materials., • To attend and complete all training courses and related competency assessments that Inizio Engage requires, to an appropriate standard and within a specified timeframe, • Develop and strengthen relationships with key customers., • To facilitate the development and provision of services across multiple healthcare sectors, as determined by the Client Account Manager, Field., • To constantly consider new and innovative approaches that potentially develop new partnership opportunities., • Complete all required administrative responsibilities in a timely manner. Some of these could include but are not limited to; daily computer updates, weekly summary of activity reports, emails and monthly expense reports., • Maintain professional registration and/or licensing as required by applicable state laws., • Attend local and national meetings and/or conferences, as required, to keep abreast of plans, activities and developments and to exchange knowledge and experience within the team., • Maintain all company equipment and materials in accordance with company instructions, • Comply with all Ashfield Policies and Procedures, along with all Client Policies and Procedures as required., • Be contactable during working hours to answer queries, • To possess a full valid US drivers license, • Perform other duties as requested. What do you need for this position? • Neuro/psych or mental health or behavioral health experience required, • Experience working in pharmaceutical industry within an HCP facing Clinical Educator role required, • Registered Nurse with 3- 5 years post-educational experience, • Territory Management experience required, • Demonstrate effective and professional communication, • Ability to present to various groups of HCPs, • Evidence of continual professional development and a desire to update professional knowledge base regularly, • Ability to travel within territory at 75% with expected overnights About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. To learn more about Inizio Engage, visit us at: _ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), 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. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

NEW Vice President Clinical Development Dermatology 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. 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Job Description: QC Chemist II, Radiopharmaceutical Contract Manufacturing, NJ5 Title QC Chemist II Location NJ5-Totowa, New Jersey Department Radiopharmaceutical Contract Manufacturing Training Curriculum ID TCU.004 Overview: The QC Chemist II will perform analysis of diagnostic and therapeutic radiopharmaceuticals for SOFIE within the Radiopharmaceutical Contract Manufacturing Division. Following SOFIE's QA program and cGMP guidelines, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and EudraLex Volume 4). Essential Duties and Responsibilities • Conduct required Quality Control analytical tests for regular production of radiopharmaceuticals for preclinical, clinical, or commercial use according to cGMP standards. • Prepare standards, samples, and mobile phase solutions for analytical methods. • Ability to perform precise production visual inspection or laboratory appearance testing of finished product requiring 20/20 vision and accurate color differentiation (with or without reasonable accommodation) to assess product quality by evaluating color, clarity and absence of visible particulates for the drug product solution and evaluating attributes of the container closure system (e.g., cracks or chips in glass vials, creases in crimps, presence of stoppers, color of flip tops, etc.) in compliance with FDA, EudraLex and Rest of World guidance. • Initiate deviation and OOS reports, lead root cause investigations • Assist in the development, implementation, and validation of Quality Control analytical methods • Follow protocols for the analysis of clinical-grade radiopharmaceuticals, validate these methodologies against quality requirements, and implement them for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards. • Validate existing analytical methods on existing or new equipment. Follow method transfer protocols for clinical and commercial-grade radiopharmaceuticals. • Write clear Standard Operating Protocols (SOPs) for QC protocols. • Review existing SOPs and suggest logical modifications based on either scientific rationales and/or regulatory requirements. • Install, qualify, and maintain laboratory equipment on site. • Collaborate with production radiochemists as required to ensure successful protocol development and radiopharmaceutical production. • Perform release testing, according to SOPs, on other materials (e.g., raw materials for radiopharmaceutical production). • Conduct environmental monitoring of environment and facilities. • Maintain all qualification and validation requirements for entering ISO classified areas. • Maintain a clean and safe working environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations. • Maintain accurate radiopharmaceutical test and validation results. • Liaise with our contract partners as needed (e.g., biotech and pharma). • Other duties as assigned. Qualifications • Bachelor's degree in Chemistry or natural science required with 2+ years of experience in analytical chemistry and instrumentation (qualification, troubleshooting and maintenance) required; a Master's degree preferred. • Experience in a GMP manufacturing environment is highly preferred. • Expertise in laboratory procedures and analytical chemistry techniques required (thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.). • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required. • Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification required. • Efficient in the use of MS Office Suite required.Ability to be detail-oriented, accountable, patient, organized, and work in a team environment with minimum supervision required. • Strong technical writing skills required. • Excellent organizational skills required. • 20/20 natural or corrected vision and normal color vision, only for performance of visual inspection or appearance testing. • Ability to work various shifts and weekends required.

Suanfarma is a life science company committed to health and progress. We specialize in the development, manufacturing, and distribution of high-quality active pharmaceutical ingredients—essential components of medicines that improve the lives of millions of people and animals worldwide. We are currently looking for a motivated professional to join our team. Duties: • Support and accompany the KAM in their commercial activities including customer visits and meeting preparation, • Summarize and monitor action items following customer meetings., • Coordinate internally to meet customer deadlines and response time, • Utilize and keep SalesForce updated to ensure timely customer management and follow up, • Process KAM’s POs and ensure correct handover to operations, • Strategically increase our win rate turning tail accounts into rising stars, • Prepare, present and ensure yearly sales performance., • Develop and grow the project pipeline for future growth., • Coordinate with Strategic planning and R&D to market relevant sales campaigns and product focus., • Adhere to the financial guidelines and policies of the company including DSO/DPO/DIO and debt monitoring., • Carry out your daily activities following the Commercial Playbook., • Coordinate and leverage collaboration between internal departments to ensure accurate and timely customer service and response to all customers., • Collaborate with internal functions to comply with both internal and external guidelines., • Educate yourself about the pharmaceutical industry and Suanfarma’svalue proposition to our customers Qualifications: • 2-3 years of Customer Service or Inside Sales experience, • Attention to detail and customer focus, • Understanding of sales and operations planning process, • Strong team player, • Problem solver with a positive attitude, • Skilled in Word, Excel, Powerpoint and Salesforce.com preferred, • Pharmaceutical industry experience preferred

Safety Partners is an Environmental Health & Safety (EHS) consulting company specializing in supporting life science and biotech companies. As an EHS Officer, you will have the continual opportunity to create, implement, and maintain EHS, programs for our growing list of life science and high-tech clients. Most of your time will be spent with clients at their locations in New Jersey and New York, developing and implementing customized programs in hazard communication, biosafety, chemical safety, emergency preparedness, radiation safety, and facilities safety. You will have a significant opportunity to interact with visionaries, researchers, and senior management at leading firms in fast-paced, highly varied environments. Being comfortable working with all different types of people in different corporate cultures is essential! We take pride in our staff having a strong science background. Being able to speak peer-to-peer is critical to our clients. As former scientists with a continual passion for learning our consultants understand what EHS policies and procedures can mean to experiments, timelines, and new products and procedures. If you are self-motivated, adaptable, willing to constantly learn, and want to be an “expert generalist” in EHS for life sciences, come join us! Job Responsibilities • Hands-on development and implementation of client EHS programs, including Biosafety, Chemical Safety, Radiation Safety, Hazard Communication, Emergency Preparedness, and Additional OSHA-specific safety programs as needed., • Establishment and maintenance of EHS permits and licenses in compliance with Federal, State, and Local regulations., • Conduct Job Safety Analyses for hazardous materials processes., • Conduct Risk Assessments to analyze and evaluate the proper handling of biological materials., • Work with client staff to bring about a high-level match of EHS culture and worker safety activities to written policies, procedures, instructions, and manuals., • Coordinate and facilitate safety committees., • Prepare and deliver training to fulfill regulatory requirements and ensure client employees are fully aware of the safety program., • Coordinate specialized training, such as RCRA, DOT, IATA, OSHA HAZWOPER, Wastewater Operator, CPR, First Aid, and AED., • Maintain complete documentation of all aspects of the EHS program. Qualifications • Bachelor's degree in Life Sciences; Biology or Chemistry degrees strongly preferred., • Master’s degree or PhD in Life Sciences preferred., • 3+ years of experience in a laboratory setting (biotechnology, pharmaceutical research, academic science, or medical technology science preferred) or EHS-related work experience. Required Skills and Competencies • Strong professional communication and written skills., • Able to positively interact both internally among the client staff and externally with regulatory agencies., • Must be highly organized with strong prioritization skills and possess the ability to manage multiple projects simultaneously., • Must have a valid driver's license, the ability to commute to various locations on a daily basis, and potentially multiple locations during the workday., • Productivity and resiliency in a dynamic, fast-paced consulting environment., • High level of professional judgment., • Must be able to lift up to 50 lbs., • Proficient in the use of Microsoft Office Suite., • Experience and comfort with public speaking. What you need to be successful in this role • Service-oriented with a personable positive attitude., • Ability to successfully negotiate and promote safety programs and services., • Strong initiative to dig into resources efficiently and effectively., • Ability to independently solve problems with little supervision but recognize when help is needed. As an equal opportunity employer, Safety Partners will provide reasonable accommodation for a disability or sincerely-held religious belief where required by law to do so.

Job Title- Clinical Data Governance Lead Location: Basking Ridge, NJ 07920 Duration: Contract till Dec 2026 with possibility to extend Duties: Job Title: Clinical Data Governance Lead • Work Schedule: 37.5 hours per week- local NJ candidate is preferred; however qualified remote based candidates would be considered and need to be able to work EST hours., • Education: Minimum Bachelor’s degree, preferably related to life sciences. Years of Experience: Minimum 15 years - bill rates will comparable to a senior level/experienced Clinical Development Business Analyst /Data Analyst Summary Experienced, senior-level individual with strong experience in clinical development (clinical study lifecycle and clinical data lifecycle) required to assist with data governance initiatives, including business glossaries, data catalogs, metadata management, data lineage, master and reference data management, data quality, data policies, data controls, data sharing, data stewardship, etc. Requires strong oral and written communication, expertise in analyzing clinical processes and data, experience meeting with and influencing senior-level leaders at all levels, adept at preparing and presenting high-quality presentations and leading workshops, and being a proactive, self-driven team player. Responsibilities Following are the immediate responsibilities of the position. This is expected to evolve over time in other areas of pharmaceutical data governance. • Provide support for biostatisticians, translational scientists, researchers, and other clinical data analysts in the governance process for accessing clinical data (no biostatistics or translational science experience needed)., • Drive data stewardship for clinical studies, sites, investigators and products., • Work with business functions to help define data definitions, standards and glossaries., • Maintaining business glossaries and catalogs in Collibra for business functions., • Drive adoption of governed data assets., • Create and deliver high quality documentation and presentations Skills: Qualifications – Required • Strong pharmaceutical and clinical background with deep understanding of clinical trial processes, study lifecycle, and regulated data environments., • Deep understanding of clinical trial data lifecycle, data types, data usage, data management, related roles and responsibilities., • Strong communication and stakeholder engagement skills, with the ability to explain data governance methodologies, standards, and business value to both technical and non-technical audiences., • Ability to lead and influence governance discussions by facilitating workshops, gathering requirements, driving consensus on definitions and standards, and supporting adoption of governed clinical data assets across the organization., • Very strong written and oral communication skills. Qualifications – Strong Plus • Experience with Master Data Management (MDM) to support the mastering and governance of critical clinical entities such as clinical studies, sites, investigators, and products., • Experience with data sharing for secondary use of clinical study data., • Strong knowledge of data governance principles and methodologies including data ownership, stewardship, and metadata management., • Hands-on experience with defining business data glossaries (terms, definitions), data standards, data-related roles, data management/governance processes, etc., • Experience with data quality, including defining data quality rules, monitoring data issues, tracking remediation, and establishing meaningful data quality measures and KPIs., • Familiarity with enterprise data governance platforms such as Collibra or similar tools used for data catalogs, glossary management, data lineage, data stewardship. Education: • Education: Bachelor’s degree required, preferably related to life sciences.

About the Company DigiPulse Technologies is a privately owned US-based IT Consulting company headquartered in New Jersey. We specialize in end-to-end technology consulting, enterprise application development, system integration, cloud engineering, and custom business solutions for Fortune 1000 clients across Financial Services, Banking, Insurance, Telecommunications, and Pharmaceutical sectors. Hiring – Sr. Software Engineer – C++ (W2 Only) | Hybrid Opportunities | Long Term Contract Locations (Hybrid): Jersey City, NJ ✅ H1B Transfer Support Available ✅ Immediate I-140 / Green Card Processing Support Responsibilities • 10+ years of hands-on software design and development experience., • Expertise in Java, C/C++, Python, and Linux., • Deep experience with low latency messaging systems (e.g., 29West, Kafka)., • Proficiency in KDB+ or other time-series databases., • Experience with Capital Markets or Brokerage systems, especially order management., • Solid understanding of the FIX protocol and FIX engines., • Familiarity with AI developer assist tools (e.g. GitHub Copilot)., • Experience with CI/CD tools such as GitHub, Maven, Jenkins, Artifactory, and uDeploy., • Hands-on experience deploying applications to AWS or other cloud platforms.

For more than 40 years, this established healthcare organization has provided customized vision benefit solutions to employer groups, associations, and healthcare networks across the United States. The company has built a strong reputation for client retention, long-term partnerships, and personalized service within the healthcare and vision industry. With a collaborative office environment and a close-knit team culture, the organization offers stability, professional growth, and long-term career potential for experienced Inside Sales professionals. This Inside Sales position is focused on recruiting and expanding a nationwide network of eye care providers through relationship-driven outreach and strategic business development. The Inside Sales Representative will work with both warm leads and self-generated prospects to grow provider participation and strengthen network coverage in targeted markets. This Inside Sales opportunity is ideal for candidates who are motivated by networking, communication, sales strategy, and building long-term professional relationships within the healthcare space. Responsibilities • Conduct Inside Sales outreach to optometrists, ophthalmologists, and healthcare providers through phone calls, email campaigns, and relationship-building efforts, • Manage both warm leads provided by the company and independently sourced cold leads through proactive business development, • Build and maintain strong professional relationships with eye care providers and healthcare networks, • Support provider recruitment efforts to expand coverage and strengthen network adequacy in assigned markets, • Track recruiting activity, provider communication, and sales progress using internal systems and reporting tools, • Collaborate with credentialing, operations, and internal departments to ensure provider onboarding is completed accurately, • Utilize Inside Sales techniques to identify opportunities for provider engagement and long-term partnerships, • Maintain professionalism and strong communication skills while representing the organization in all provider interactions, • Meet team goals and performance metrics tied to provider recruitment and Inside Sales initiatives, • Participate in ongoing training and development to strengthen Inside Sales and recruiting effectiveness Qualifications • Previous experience in Inside Sales, provider recruitment, healthcare sales, or business development required, • Medical, pharmaceutical, healthcare, or provider network recruiting experience strongly preferred, • Strong cold calling, lead generation, and relationship management skills This Inside Sales opportunity offers the chance to join a stable and growing organization with a long-standing reputation in the healthcare industry. The company is seeking an Inside Sales professional who is motivated, relationship-focused, and eager to contribute to a high-performing and collaborative team. Candidates looking for a long-term Inside Sales career with growth potential, bonus opportunities, and a supportive office culture are encouraged to apply.

Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company. Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. POSITION SUMMARY This role supports commercial contracting operations by translating contract terms into standardized rebate calculation logic, ensuring accurate quarterly rebate calculations for contract-based rebate programs, and maintaining rebate tracking tools and historical data integrity. The position also supports the integration of contract and sales data for reporting and validation, collaborates with cross-functional teams to ensure contract logic is accurately reflected in reporting solutions, supports validation and follow-up for other rebate programs as needed, and maintains structured, audit-ready documentation of deal history, amendments, and version changes. KEY ROLES AND RESPONSIBILITIES Rebate Structure & Tracker Management • Standardize rebate calculation frameworks across contract-based rebate programs, including GPO and direct purchase contracts, and support other programs as needed., • Maintain rebate tracking tools and historical data to support accurate quarterly rebate calculations and validation activities., • Translate contract rebate terms into calculation logic and ensure quarterly rebates are calculated accurately, while supporting other rebate validations as needed. Contract-Sales Data Integration • Develop and manage mapping frameworks across GPOs, aggregators, and hospital rosters., • Link contractual terms with actual sales data to enable accurate rebate calculation and contract performance tracking., • Align commercial agreements with transactional data for reporting and validation, and support follow-up on rebate inquiries or disputes as needed., • Power BI-Based Rebate Analytics & Monitoring, • Work with the reporting team to ensure contract logic and rebate requirements are reflected accurately., • Support translation of contract terms and rebate methods into business rules for dashboard development., • Review rebate outputs and support monitoring to improve reporting accuracy and visibility. Knowledge of Contracting and Product Program Management • Establish structured processes for managing product program rebate life cycle, including contract amendments and version tracking., • Knowledge of customer and affiliation relationships across different line of business and distribution channel, • Ensure consistency between contract records and Finance month-end closing data., • Maintain audit-ready documentation of historical deal terms and changes with the Finance team. WORK EXPERIENCE • 3+ years of experience in Pharma/Biotech or related industries, preferably in Pricing, Contracting, Finance, Sales Operations, or other data-intensive commercial functions., • Experience supporting contract administration, rebate processing, data reconciliation, or commercial reporting is strongly preferred. QUALIFICATIONS • Advanced Excel Skills (Required): Strong proficiency in formulas, pivot tables, lookups, and data validation to support rebate calculations and reporting., • Attention to Detail: Strong accuracy in reviewing contract terms, validating rebate calculations, and reconciling data across multiple sources., • Communication and Coordination: Ability to work effectively across Finance, Sales, and other cross-functional teams to support reporting, resolve issues, and follow up on rebate-related inquiries or disputes. EDUCATION Bachelor’s Degree required in business or related field; advanced degrees, MBA, MS in business or related field is a plus. CORE COMPETENCIES • Analytical Rigor: Ability to interpret contract terms, process large datasets, and validate rebate calculations with a high degree of accuracy., • Operational Discipline: Strong attention to detail in maintaining contract records, supporting quarterly rebate processes, and ensuring audit-ready documentation., • Collaborative Mindset: Effective communication skills to coordinate with Finance, Sales, and reporting teams, and to support timely follow-up on rebate issues and disputes., • Business Agility: Ability to manage multiple priorities in a fast-paced commercial environment while maintaining accuracy, consistency, and responsiveness. Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #LI-MDR-D

Corporate Associate – Newark Sills Cummis & Gross P.C. is a full-service commercial law firm with offices in New Jersey, New York and Florida. At Sills Cummis & Gross, our goal is to make sure you are exposed to high-profile cases and receive the necessary tools to exceed client expectations. Our attorneys are innovative, creative, and collaborative; giving you the platform to flourish in an environment where your ideas matter. When you join our group of attorneys, you will work alongside some of the best professionals in their field of practice who will mentor you and help develop your skills. The Firm not only makes a commitment to our clients, we also make a commitment to our attorneys. If you are ready to join an engaging, inclusive firm where you will have the ability to shape your future, view our open positions and apply. The Firm’s highly credentialed and experienced corporate practice group attorneys handle a broad range of public and private transactional, compliance and corporate counsel assignments. Our clients are international and domestic investors, lenders, entrepreneurs and operating companies, from startups to small and midsized entities to Fortune 500 corporations. The Firm’s experience spans a diverse range of industries, including financial services, pharmaceutical and other life sciences, technology, insurance, real estate, construction, public utilities, health care, education, food and beverage, hospitality, media, consumer products and industrial manufacturing. Our Corporate Practice Group is seeking a highly skilled and motivated Corporate Attorney with 7+ years of experience to join our New Jersey office. The ideal candidate will have significant experience handling sophisticated transactional, advisory, and general corporate matters for emerging growth and established companies across a range of industries, including life sciences. Sills Cummis & Gross is an equal opportunity employer. Requirements • Represent clients in a broad range of corporate and transactional matters, including mergers and acquisitions, joint ventures, strategic alliances, restructurings, and general corporate counseling., • Structure, draft, and negotiate complex commercial agreements, including SaaS, licensing, distribution, supply, professional services, outsourcing, and product development agreements., • Counsel clients on corporate governance matters, shareholder arrangements, employment agreements, and related disputes., • Assist companies and investors with early-stage and venture capital financings, bank financings, strategic investments, and exit transactions, including mergers and acquisitions., • Collaborate closely with clients to provide practical, business-oriented legal solutions tailored to their objectives and industry context. Qualifications • 7+ years of relevant corporate transactional experience., • Must be admitted to the New Jersey bar; admission to the New York bar is strongly preferred (a plus)., • Strong experience in mergers and acquisitions, corporate governance, commercial contracts, and financing transactions., • Excellent drafting, negotiation, and client counseling skills., • Ability to manage multiple matters independently while working collaboratively within a team. Salary and Benefits • $240,000 – $280,000 annually, commensurate with experience., • We offer a comprehensive benefits package that includes medical, dental, and vision coverage, a 401(k) retirement plan, paid time off, and other firm-sponsored benefits and perks.

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

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 DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility 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 at any time with or without notice.

Job DescriptionJob Summary We are seeking an experienced Pharmacist In Charge (PIC) to join our team at Family Care Pharmacy! As a pharmacist in charge, you will be receiving incoming prescriptions, reviewing them for accuracy, and filling them with the correct medicine and dose. You will also be talking with customers to help them understand their medications and possible side effects, advising them on medication storage, and maintaining a safe, clean work environment. The ideal Pharmacist candidate is comfortable working in a fast-paced environment, has excellent communication and interpersonal skills, and is familiar with pharmaceutical best practices. This role is a TEMPORARY to PERMANENT Position based on experience and performance. Responsibilities • Dispensing prescriptions, compounding, and selling pharmaceuticals, medicines and related drug items, on behalf of the Company., • Keep in proper form all records required relating to the purchase and dispensing of all prescription required drugs including controlled substance requirements., • Medication management and ensuring appropriate handling and safety., • Eliminate from stock all misbranded and adulterated drugs including outdated drugs and drugs mot properly labeled., • Provide for the proper storage of drugs in order to prevent loss or deterioration., • Insure coverage of the pharmacy by licensed pharmacists., • Insure against unauthorized refills of prescriptions and unauthorized sale of legend drugs., • Insure against unauthorized entry into the pharmacys dispensing and compounding area and ensure appropriate security., • Patient support and education, maintain accurate patient records and documentation., • Any and all tasks by a licensed professional in this field., • Maintain license status and continuing education credentials for professional license., • Ensure that no prescription required drugs or devices are sold at wholesale unless the pharmacy possesses a New York State Board of Pharmacy wholesaler registration., • Be certain that the pharmacy is properly registered and operating in accordance with the present laws, rules and regulations., • Issue verbal and written notices to employees and subordinates concerning the laws, rules and regulations (Federal, state and local) relative to proper pharmacy practice., • Additionally, the pharmacist is responsible for all day-to-day functions associated with the operation, maintaining staffing, safety and maintenance of the pharmacy including dealing with the mandatory local, state, and federal regulations regarding the pharmacy., • Are classified as an exempt employee. Schedules are written in two week increments and may fluctuate to accommodate staffing and days off for an extended period. Qualifications • Must hold a current state pharmacist license or degree, • Strong customer service skills, • Excellent attention to detail, • The ability to multitask and shift priorities, as needed, • A Pharm.D. (Doctor of Pharmacy) with immunization certification, • 1-3 Years Experience as PharmacistSchedule, • Monday-Friday, • Full Time, • 40-50 hoursLocation: Totowa, NJ Pay Rate • Bi Weekly, • $65-70 hourly based on experienceBenefits, • Paid time off, • Health Insurance, • Vision, • Dental, • Training and Development

Job DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-O-Vator available for use., • Small breakroom available. No on-site cafeteria available.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 at any time with or without notice.

Job DescriptionBenefits: • Paid time off Job Title: PHARMACIST IN CHARGE MUST HAVE RETAIL EXPERIENCE Position Type: Full-Time (Immediate Joining Preferred and Available to work weekends) Job Description: Icare Pharmacy Plus is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly., • Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices., • Collaborative Care: Work with healthcare providers to manage and improve patient care., • Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock., • Insurance Processing: Handle insurance claims processing and reimbursement efficiently., • Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements: • Must Have: A valid state required pharmacist license, • Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: • Strong knowledge of federal and state pharmacy laws and regulations., • Proficiency with pharmacy management software systems., • Excellent communication and interpersonal skills., • Ability to work efficiently in a fast-paced environment., • Strong attention to detail and organizational skills., • Commitment to providing exceptional patient care. Preferred Qualifications: • Certification in Medication Therapy Management (MTM)., • Experience with inventory management and cost-saving measures., • Proven track record of effectively managing a pharmacy team. Benefits: • Performance-based bonus, • Competitive salary, • Paid time off, • Training and development opportunities, • Wellness resources Why Join Us: • Supportive Environment: Be part of a team that values and supports your contributions., • Growth Opportunities: Advance your career with opportunities for professional development., • Balanced Schedule: Maintain a healthy work-life balance with our balanced work schedules., • Competitive Packages: Benefit from competitive salary packages and growth opportunities. We look forward to reviewing your application. Icare Pharmacy Plus is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job Description Essential Duties & Responsibilities Answers questions and provides information to patients on compound ingredients, dosage, storage medication(s), use of medication(s), pertinent interaction(s) and other information relating to the compounded medication(s) Mixes pharmaceutical preparations and appropriately labels containers Establishes and maintains compounding records and enters prescription data accurately Assists the clinic team in providing patient care Assists in maintaining inventory of the IV area, including, but not limited to: labels, medication, compounding ingredients, vials, etc. Cleans and helps maintain equipment and work areas according to SOPs Maintains proper storage and security conditions of vitamins, ingredients and finished compounds Follows established SOPs, assists with formulation development of new SOPs and data entry, and competence in mathematical calculations Effectively communicates with prescribers and other healthcare professionals, conveying appropriate information to designated staff for proper compounding of IV vitamins and IM Quickshots Attends professional meetings and interacts professionally with patients, staff and external associates as needed Delegates tasks to other staff members according to individual strengths/weaknesses. Oversees SOP implementation, training verification, formulation of medications, CQI, quality of ingredients, staffing requirements, patient-specific needs, and any other aspect of work in the IV area Evaluate, plan, implement and document nursing care for clients Prepare IV & IM vitamins for administration with appropriate technique Inserting, monitoring and removing IV - ensuring needles and tubing stay in place during treatment, and procedure is done as easily and comfortably as possible. Oversight of the client during the infusion process Reviewing treatment plans and ensuring the clients are up to date with labs and f/u appointments Clean and maintain infusion room & sterile hood Various Office and Customer Service duties to include but not limited to scheduling appointments, verifying the correct forms are filled out and complete, reviewing health history forms, and providing excellent customer service Performs venipuncture. Possible accesses implanted ports or PICC lines Orders and maintains adequate IV supplies Triage's patient phone calls as needed and documents relevant information in the client’s chart Follows Daily, Weekly, Monthly Requirements for Lab and staff Additional tasks as needed Qualifications Continuous speaking, hearing and visual effort. Frequently required to walk, stand and sit. Use hands to use/hold various compounding equipment and machinery. Reach with hands and arms. Occasionally required to climb, stoop, kneel, crouch or crawl to manipulate equipment or storage of supplies. Occasional lifting of equipment or supplies weighing up to 50 pounds and carrying objects of varying weights. Position requires being careful about detail and thorough in completing work tasks. Position requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior (even in very difficult situations). Position requires being open to change (positive and negative) and to considerable variety in the workplace. Position requires managing one pharmacy technician and verifying compounds and processes performed by clinic staff. Possible travel for training and symposiums. Stress due to pressures with dealing with a number of different personalities where patience is required. Frequent work interruptions. Strong venous access skills; must be able to access peripheral veins easily without backup. Availability to work evening and weekend hours if needed, and flexibility to work alternate shifts on short notice. Patient-centric attitude and commitment to quality client care Outstanding organization skills and ability to multi-task in a fast-paced, high-energy environment Initiative, creativity, problem-solving ability, adaptability, and flexibility Ability to work without direct supervision and practice autonomously Have a working knowledge of all the infusions, their purpose, and side effects Educate /market other services available at the center ■ Ability to commit to at least hours of coverage per month, with hours on Saturday or Sunday Specific Qualifications RN active, unrestricted license in the state of New Jersey; graduate of accredited Nursing program Minimum of 2 years infusion experience required having performed no less than 15,000 IV sticks Previous experience administering IV infusion therapy Current BLS CPR certification Company Descriptionwww.TheDRIPBaR.comwww.TheDRIPBaR.com

Job DescriptionJob Title: Pharmacist In Charge PIC Pharmacy Name: Presidential Pharmacy Location: 121 W Broadway, Paterson, NJ - 07522 Position Type: Full-Time Immediate Start Preferred Company Overview: Presidential Pharmacy is looking for a dedicated and experienced Pharmacist to join our team. We are committed to delivering exceptional patient care and ensuring that our pharmacy operates in full compliance with all relevant laws and regulations. If you are passionate about pharmaceutical care and ready to make a difference, we invite you to apply. Candidates available for immediate start are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide thorough guidance on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure compliance with federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain precise records and responsibly manage controlled substances., • Staff Training: Train and mentor pharmacy staff to uphold best practices., • Collaborative Care: Collaborate with healthcare providers to enhance patient care., • Inventory Management: Monitor and manage inventory levels to avoid shortages or excess., • Insurance Processing: Efficiently handle insurance claims and reimbursements., • Customer Service: Professionally address and resolve patient inquiries and concerns.Job Requirements:, • Required: Valid pharmacist license as per state regulations., • Required: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: 3-5 years of experience in a pharmacy setting.Skills:, • In-depth knowledge of federal and state pharmacy laws and regulations., • Proficiency in pharmacy management software., • Excellent communication and interpersonal abilities., • Strong organizational skills with a keen attention to detail., • Ability to thrive in a fast-paced environment., • Dedication to providing outstanding patient care.Preferred Qualifications:, • Certification in Medication Therapy Management (MTM)., • Experience in inventory management and implementing cost-saving measures., • Proven success in managing a pharmacy team effectively.Benefits:, • 401(k) matching, • Performance-based bonuses, • Competitive salary, • Paid time off, • Opportunities for training and professional development, • Wellness resourcesPerks:, • Competitive Compensation: Attractive salary and benefits packages., • Supportive Environment: Work within a collaborative team that values your contributions., • Career Advancement: Opportunities for growth and development within the organization., • Work-Life Balance: Flexible schedules to support a healthy work-life balance.Why Join Us?, • Supportive Environment: Be part of a team that values your input and fosters your growth., • Growth Opportunities: Advance your career with ample professional development options., • Balanced Schedule: Enjoy a healthy work-life balance with our flexible schedules., • Competitive Packages: Benefit from attractive compensation and growth potential.We look forward to receiving your application! Presidential Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees.

Job Description Job Title: Fabrication Mechanic (1st Shift) Department/Division: Fabrication Reports to: Sr. Fabrication Manager, Production & Site About LTS: LTS is a global leader in transdermal and oral thin film drug delivery technologies. Our teams have pioneered breakthroughs such as the first contraceptive patch, nicotine patch, oral active ingredient film, and Parkinson’s patch. When you join LTS, you become part of a team that continues to shape the future of patient care and bring life changing therapies to market. At LTS, our purpose drives everything we do: We CARE. We CREATE. We DELIVER. We’re committed to fostering an employee experience that reflects our innovation — supportive, collaborative, and empowering. Across our New Jersey and Minnesota locations, you’ll work alongside knowledgeable experts on diverse projects in an environment where every day is different and your contributions truly matter. Job Summary We’re seeking a Fabrication Mechanic to support our pharmaceutical manufacturing operations in West Caldwell, NJ. In this role, you’ll be responsible for setting up, maintaining, repairing, and troubleshooting manual and automated production equipment to ensure safe, compliant, and efficient manufacturing. If you enjoy hands-on mechanical work, problem-solving in a regulated environment, and working with advanced production equipment, this role could be a great fit. This is a full-time role located in West Caldwell, NJ. • 1st Shift: 6:15 AM – 2:30 PM, Monday-Friday What You Will Do: • Set up, adjust, repair, and maintain pharmaceutical manufacturing and packaging equipment, • Troubleshoot mechanical and operational issues during production, • Perform equipment changeovers and provide support to fabrication operators, • Conduct routine autonomous and preventive maintenance, • Analyze equipment failures, identify root causes, and implement corrective actions, • Communicate maintenance activities and findings with operators and supervisors, • Follow all cGMP, FDA, DEA, and internal SOP requirements, • Promote and uphold a strong safety-first culture Your Background: • High school diploma or equivalent, • At least 2 years of experience in pharmaceutical manufacturing, • Strong mechanical and troubleshooting skills, • Ability to read and understand technical drawings, • Ability to lift up to 50 lbs. and stand for extended periods, • Ability to gown and work in a manufacturing environment, • Willingness to wear required PPE (safety glasses, hearing protection, respirator, gloves, Tyvek suit, etc.) We Offer • Competitive compensation and benefits package, • Opportunities for professional growth and development, • A collaborative and supportive work environment, • The chance to contribute to improving patient lives If this sounds like you, we want to hear from you! LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job DescriptionPharmaceutical Sales Rep (Entry Level or Experienced) There's something special about working for us and it's reflected in our focus on the patients we serve, the way we treat each other and the results we achieve together as a company. We are happy to announce that we are have a Pharmaceutical Sales Representative opportunity available in your area. Products promoted are new and very innovative. This opportunity is either great for highly experienced industry reps or those sales professionals looking to break into the Pharmaceutical industry. You will be mostly covering Primary Care physicians in this opportunity. Pharmaceutical Sales Rep Purpose & Scope: Achieve territory sales goals by promoting pharmaceutical products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent our several healthcare in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers. Pharmaceutical Sales Rep Essential Job Responsibilities: • Effectively promote and educate physicians on the use of our pharmaceutical products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means., • Work during the day in the field each week, as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc., • Ensure high performance levels of call and field productivity., • Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices,, • Compliance guidelines, and required promotional regulations, • Execute company-approved Product Marketing plans and territory/regional business plan activities, • Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management, • Coordinate promotional efforts with peers across franchises and co-promotion alliance partners. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g.., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines, • Ensure optimum territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports, • Expected to accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales ManagerOrganizational Context: It is important for individual's in this Pharmaceutical Sales Rep position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge. This particular Pharmaceutical Sales Rep position: • It is a physician customer facing pharmaceutical sales rep opportunity, • Reports to a National Sales Manager as well as District Sales Manager, • Maintains territory responsible for managing several pharmaceutical products, • Assumes lead role within primary care and specialty counterpart working relationships, • Balances territory and regional work and projects, while maintaining solid level of sales performance, • Exhibits strong level of skill in competencies, • Demonstrates sales influence within territory and often within regionPharmaceutical Sales Rep Qualifications (required):, • Some sales experience or sales abilities, • Strong knowledge of pharmaceutical products and industry knowledge, • Strong communication, facilitation and presentation skills, • Proactive; can do approach; takes ownership of situations, • Demonstrates problem solving ability; analytical; business acumen, • Solid motivational and persuasion skills, • Must be able to acquire all industry credentials with certifications, • Demonstrates team orientation, • Proven record of sustained high sales performance and achievement, • Proficient in MS Office SuiteTake the next step in your career and APPLY TODAY. We will contact all qualified applicants for interviews. Powered by JazzHR ILNJMrZN7b

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Regional Sales Director is a first-line sales leadership role responsible for building, developing, and leading a high-performing specialty sales team supporting the launch and growth of an innovative mental health therapy. This leader will drive regional execution of commercial strategy by partnering with certified treatment centers, psychiatrists, and integrated care systems while ensuring alignment with regulatory, safety, and patient-access frameworks. The Regional Sales Director will play a critical role in shaping a new therapeutic category, and creating a culture of integrity, collaboration, and patient-centricity. Location: Remote in New York (New York, NY, Philadelphia, PA, Newark, NJ). Reports to: Director, National Sales. Roles and responsibilities (Include but are not limited to): • Recruit, onboard, and lead a team of Territory Account Managers, • Foster a high-accountability, psychologically safe culture that promotes coaching, development, and collaboration, • Set clear expectations and performance standards aligned with company launch objectives, • Drive successful regional execution of the commercial launch strategy and identify opportunities to expand the treatment ecosystem, • Ensure field readiness around clinical data, patient identification, treatment protocols, and site-of-care logistics, • Foster strategic relationships with psychiatrists, treatment centers, behavioral health systems, academic centers, and Key Opinion Leaders (KOLs), • Partner cross-functionally with Medical Affairs, Market Access, Training, Patient Support, etc., • Provide field insights to inform brand strategy and launch optimization, • Analyze regional performance metrics and develop action plans to drive results, • Manage regional budgets, forecasting, and territory alignment, • Conduct regular field coaching to strengthen clinical selling skills and consultative engagement with mental health providers Candidate Profile: • Bachelor's degree required (advanced degree preferred), • 8-10+ years of pharmaceutical or biotech sales experience, • 5+ years of first-line sales leadership experience, • Demonstrated success launching specialty or neuroscience therapies, • Experience in psychiatry, CNS, or behavioral health markets, • Experience launching therapies requiring site certification, REMS, or specialized administration models and/or a background working with IDNs, academic medical centers, and specialty treatment sites, • Experience building teams in startup or pre-launch biotech environments 【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$180,000—$230,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. This role is a project-based consulting opportunity to conduct medical reviewing on an as-needed basis. This is not a full-time position. Roles & Responsibilities • Provide medical expertise on development-related or emerging cardiac safety concerns, • Responsible for medical monitoring tasks, • Provide medical input throughout the development process, • Provide medical input into the development and execution of study documents and plans, such as study protocol, IB, SMP, DMP, SAP, Lab manuals, etc., • Provide significant expertise as primary medical reviewer of individual adverse event reports, clinical, and safety documents, • Lead safety activities on assigned product(s) that may include interactions with other functional groups in the company, • Responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations, • Responsible for strategies in monitoring and analysis of cumulative safety information, • Maintains significant knowledge of global and local regulations and guidance as they pertain to medical review and safety reportingJob Requirements, • Medical degree required (MD or equivalent), • Specialty in Cardiology or comparable experience in Cardiology, • 5 or more years of clinical experience and/ or research experience required, • Relevant experience in medical monitoring and/or medical reviewer in pharmaceutical industry, • Excellent scientific writing skills, • Ability to understand clinical data, • Proficiency with MS Office applications, • Good communication skills, • Strong knowledge of current regulatory practices and domestic and international regulations Powered by JazzHR TohLV7ALPB

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.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 at any time with or without notice.

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Summary: This is an individual contributor role that supports the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH, local Regulatory requirements and NS Pharma standard operating procedures. This is a hybrid role that requires employees to come into the office twice a week. Essential Duties and Responsibilities: • Assist in the planning, implementation and management of assigned regional or global clinical studies., • Facilitate CRO./vendor selection process., • Maintain oversight of assigned study vendors (e.g. central labs)., • Perform assigned activities in the selection of clinical sites., • Attend and participate in site visits including pre-study assessments, site initiations, co-monitoring and ad-hoc site visits based on the study’s needs., • Review site visit reports, identify issues and ensure issues are resolved., • Oversight of patient recruitment and development of recruitment strategies and plans., • Track, review, report and present study metrics including enrollment, protocol deviations, issues, risks, data resolution, and other study related metrics., • Support the development of study related documentation (protocol, ICF, CRF, operations manuals, etc.); facilitate internal review of these documents as assigned., • Tracking of clinical data, regulatory documents, and patient, • Assure compliance of investigational sites with SOPs, FDA regulations, ICH guidelines and protocol requirements., • Facilitate internal review of clinical trial agreements and ancillary agreements, • Implement and maintain study-specific training program., • TMF oversight review during study conduct and TMF management during study closeout., • Support creating and maintaining clinical SOPs as part of global QMS., • Perform administrative tasks (e.g. setting-up and facilitating meetings, clinical registrations)., • Perform other tasks and functions as needed. Qualifications: • Thorough understanding of clinical operations including strong knowledge on essential documents as related to the planning, launching, and closing clinical studies, • Must be able to manage and coordinate with the Clinical Lead(s), Study Manager(s), Operations Program Lead and study team members at Headquarters Office in Japan to achieve study objectives and team goals, • Must have the ability to identify and manage/solve study team’s performance issues if they arise with minimal supervision, • Must have demonstrated ability to support the development and management of various aspects of the study operational plans from start-up to close-out., • Must be able to work effectively in a multi-cultural, global team environment and support drug development collaboration with global project teams, Headquarters Office in Japan, external partners and vendors., • Ability to handle multiple tasks and prioritize., • Strong organizational, attention to details, communication and presentation skills., • Team player, flexible, ability to adapt to change, • Ability to interact with Investigators in-person to discuss protocol requirements and study drug., • Ability to travel 15-25% monthly within the US and/or outside of US. Education and Experience: • Bachelor’s Degree in sciences (highly preferred) or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience, • Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials., • Program and project management experience preferred., • Global clinical trial experience is also preferred. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $110,000 to $135,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training, • Flexible Work Arrangement Programs Applications will be accepted until July 31, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Job DescriptionCOMPANY OVERVIEW: At F.P. Developments, Inc., we recognize that our employees are our greatest asset. We foster a supportive environment where each team member’s unique strengths and perspectives are valued. Our state-of-the-art, 25,000 sq. ft. climate-controlled facility is a hub for innovation and collaboration, empowering our team to grow both personally and professionally. For 60 years, F.P. Developments has been a cornerstone in the pharmaceutical, biotech, and medical device industries. Established in 1963, we leverage the latest technologies and good old-fashioned ingenuity to solve today’s manufacturing and compliance challenges, consistently meeting our customers' specific requirements with precision and dedication. Join us and be a part of a legacy of quality and innovation. F.P. offers full medical, dental and vision benefits as well as 401k matching, holidays and PTO. SUMMARY: As an Electromechanical field service technician at F.P. Developments, you will train and assist in the fabrication, assembly, electrical wiring, controls programming and servicing of machines and robots used in primary pharmaceutical manufacturing and hospital pharmacy compounding. You will be a self-starter, a quick learner, and open to advancement and travel opportunities. You will also participate in our innovation process, offering suggestions around new capability development. THIS POSITION REQUIRES 15-20% TRAVEL ANNUALLY DUTIES AND RESPONSIBILITIES: • Assembling machines and robots:, • Utilize electrical and mechanical blueprints and schematics to assemble large and small machinery, • Collaborate with engineering and fabrication staff to ensure high quality, durable construction, • Analyze controls programming for PLC and robot automation to troubleshoot and simplify code structure, • Servicing and refurbishing machines and robots (onsite and in the field):, • Troubleshoot and fix machine issues across mechanical, electrical and controls, • Identify and document preventative maintenance procedures for new machines, • Inspect mechanical components for wear and electrical panels for loose and missing components and recommend necessary fixes, • Replace worn or missing parts and ensure machine functionality, • Innovation support, • Research issues and recommend potential solutions, • Stay up to speed with new and emerging technologies applicable to our products, • Collaborate across engineering and fabrication departments to select and implement solutions QUALIFICATIONS: • Education:, • High school diploma or equivalent with electromechanical and controls programming experience OR, • Electrical engineering undergraduate experience, • Skills:, • Mechanical aptitude, • Basic understanding of electrical schematics/wiring, • Basic understanding of PLC programming, • Follow through and follow up, • Strong organizational skills with the ability to manage multiple tasks effectively, • Attention to detail, ensuring all tasks are completed accurately and on time., • Ability to manage time effectively and prioritize tasks in a fast-paced environment, • Strong teamwork and collaboration skills COMPETENCIES: • Customer Service: Exceptional customer service skills with a focus on clear, effective communication and responsiveness to customer inquiries and needs, • Attention to Detail: Meticulous in checking and confirming all aspects of logistics operations, including deliveries, shipments, and inventory, • Openness to Feedback: Highly receptive to feedback, seeking continuous improvement and adjusting based on input from colleagues and customers, • Teamwork: Strong team player, able to collaborate effectively with multiple departments and contribute to a positive work environmentPHYSICAL DEMANDS AND WORK ENVIRONMENT:, • Continually required to stand, walk, sit, • Continually required to utilize hand and finger dexterity, • Occasionally required to climb, balance, bend, stoop, kneel or crawl, • Continually required to talk or hear, • Continually utilize visual acuity to operate equipment, read technical information, and/or use a keyboard • Occasionally required to lift/push/carry items up to 100 pounds, • Frequently required to work near moving mechanical parts and always observe safety precautions, • Ability to travel and work independently The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Powered by JazzHR VYpHj30fSs

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs. Responsibilities: • Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance, • Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products, • Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission – safety component, • Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents, • Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed, • Effectively write, review and provide input on technical documents independently, • Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.), • Responsible for implementing risk management strategies for assigned products, • Proactively engaging, inspiring, coaching and mentoring team and colleagues, • Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader, • Strong team player, able to adapt and work in a fast pace environment, • Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Qualifications, • MD / DO with 2+ years of internal medicine residency with patient management experience required; PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required, • 5 - 8 years of Pharmacovigilance (PST lead role equivalent) / Clinical Development experience in the pharmaceutical industry required, • Oncology experience strongly preferred, • Effectively analyze and guide analysis of clinical data and epidemiological information, • Effectively present recommendations / opinions in group environment both internally and externally, • Write, review and provide input on technical documents, • Work collaboratively and lead cross-functional teams, • Ability to lead cross-functional teams in a collaborative environment Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionJOB DESCRIPTION:The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. RESPONSIBILITIES:Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc. Review CRF, database design, and edit check specs Review study quality surveillance plan and monitor study conduct Prepare and/or review SAP, TFL shells and specifications for variable derivation Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables Provide statistical and validation support for statistical analysis, analysis datasets and TFL Review study report, manuscripts and other documents related to statistics Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents Perform other ad-hoc statistical activities as needed Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming Participates in monitoring CRO activities and reviewing CRO deliverables Other duties as assigned QUALIFICATIONS:Education: Ph.D. or MS in Statistics or Biostatistics Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience Excellent knowledge of SAS computer package Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines Excellent organizational skills, time management, and ability to meet established deadlines. Excellent communication and interpersonal skills to effectively interface with others Exceptional interpersonal skills and problem-solving capabilities Ability to work independently and collaboratively Ability to provide leadership for the CRO statisticians and statistical programmers PHYSICAL AND MENTAL REQUIREMENTS:Ability to multitask Adapts to change Maintain composure under pressure Ability to follow verbal or written instructions and use of effective verbal communications Adapts change, adjust change and grasps information quickly Examine and observe details

Job DescriptionHuman Resources Manager Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Support the continuous improvement of the HR function through development and implementation of HR programs. Provide comprehensive HR support to employees and management across assigned service departments. • Support line managers in the process of new employee orientation., • Provide HR Partnering management coaching and counseling., • Act as HR Business Partner to assigned business areas., • Provide Compensation analysis and reporting., • Design and execute recruitment strategies., • Support line managers in the recruitment and selection process where appropriate., • Manage employee relations which emphasizes open communications, equal opportunities and treatment, • Manage HR-related queries and may work independently or in conjunction with senior members of the HR team and line management on issues.REQUIREMENTS, • Bachelor's Degree Required, • 7 years experience within an HR function as generalist; ER, Compensation, TA strategy., • 5+ years pharmaceutical industry., • Expert coaching and counseling skills, • Good computer skills, including Microsoft Office applications and HRIS applications, • Strong verbal and written communication skills and very good interpersonal skills, • Strong attention to detailSUBMIT: info@lynkxstaffing.com

Job DescriptionBenefits: • 401(k) matching, • Competitive salary, • Flexible schedule, • Paid time off, • Training & development, • Wellness resources, • Opportunity for advancement Job Title: Pharmacist Pharmacy Name: Sinai Pharmacy Location: 121 W Broadway, Paterson, NJ - 07522 Position Type: Full-Time (Immediate Joining Preferred) Job Description: Sinai Pharmacy is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly., • Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices., • Collaborative Care: Work with healthcare providers to manage and improve patient care., • Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock., • Insurance Processing: Handle insurance claims processing and reimbursement efficiently., • Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements: • Must Have: A valid state required pharmacist license, • Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: • Strong knowledge of federal and state pharmacy laws and regulations., • Proficiency with pharmacy management software systems., • Excellent communication and interpersonal skills., • Ability to work efficiently in a fast-paced environment., • Strong attention to detail and organizational skills., • Commitment to providing exceptional patient care. Preferred Qualifications: • Certification in Medication Therapy Management (MTM)., • Experience with inventory management and cost-saving measures., • Proven track record of effectively managing a pharmacy team. Benefits: • 401(k) matching, • Performance-based bonus, • Competitive salary, • Paid time off, • Training and development opportunities, • Wellness resources We look forward to reviewing your application. Sinai Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionSalary: Who arePrescient? Prescient is a specialist global consultancy focused exclusively on the biopharmaceutical industry. Following the recent acquisitions of Uptake and Dolon, Prescient nowoperatesacross four core practices: Commercial, Medical, Competitive Strategy and Value, Pricing & Access. Together, we deliver best-in-class intelligence,evidenceand strategic consulting to leading biopharma organizations worldwide. Our work supports clients across the full product lifecycle,from early pipeline through post-launch,deliveringtimelyinsights and strategic recommendations that enable informed decision-making across commercial, medical, competitive intelligence, evidence generation and market access function. Within our Medical practice, we deliver integrated solutions across three core pillars - Medical Strategy & Planning, Evidence Generation Strategy, and Organizational Excellence - enabling clients to strengthen medical impact, accelerate decision-making and build future-ready medical organizations. Increasingly, our differentiation comes from pairing genuine scientific and technical depth with strategic medical affairs judgement. About the role As an Engagement Manager, you will lead the delivery of strategic medical affairs engagements while driving business growth and developing the teams around you. This role spans our three core pillars medical strategy and planning, evidence generation and organizational excellence and calls for a consultant who pairs strong technical grounding in real-world evidence (RWE), health economics and outcomes research (HEOR) and epidemiology modelling with the medical affairs understanding to put that evidence to strategic use. Our clients medical affairs leaders at leading pharmaceutical and biotech companies increasingly expect partners who can do more than synthesise their thinking. They want technical depth they can trust, fluency in how medical affairs operates, challenge to their assumptions, and clear answers to so what and now what. You will be central to meeting that expectation, with a primary client base in the U.S. and a global perspective on medical strategy, evidence generation, and drug development. What role will I play on projects? You will lead engagements end to end; scoping the approach, directing the work and owning the quality and strategic relevance of what we deliver. You will help clients address challenges across medical planning and strategy, integrated evidence generation, launch readiness, field medical optimization and operating-model design. • Lead client engagements end to endacross medical strategy, evidence generation and organizational excellence. You will oversee research, analysis and the design of deliverables such as strategic and medical plans, evidence roadmaps, operating models and client workshops., • Bring technical depth where it matters.Direct or guide RWE study design, literature reviews and epidemiology work, applying the right level of methodological scrutiny so findings withstand expert review., • Ground the work in medical affairs strategy.Connect evidence and analysis to clients medical objectives evidence-generation planning, scientific communication, field medical and launch demonstrating a clear understanding of how medical affairs creates value., • Own the so what and now what.Translate complex evidence and analysis into clear strategic implications and recommended actions; pressure-test interpretations and bring perspectives on what clients should do differently., • Identify and pursue new businesswithin existing and new clients; develop proposals, scope and cost engagements accurately and position the practice competitively at the executive level., • Manage, mentor, and develop direct reports and project teams,setting clear expectations, building both technical and strategic capability, and reducing variability in how the team delivers., • Manage workstreams and stakeholders,ensuring coordination, efficient communication and timely delivery against a high standard of quality., • Contribute to the evolution of the practiceby helping shape new capabilities and offerings across medical strategy, evidence generation and organizational excellence. What skills and experience do I need for this role? • Advanced degree strongly preferred -PhD, MD, MS/MBA combination or masters (MS, MPH, or equivalent) in a life-sciences, epidemiology, health economics, biostatistics or related discipline., • 57 years of relevant professional experience,with a strong foundation in medical affairs, evidence generation or life-sciences strategy., • Prior consulting experience is required-a proven ability to deliver impactful client work and manage engagements in a consulting environment., • Strong understanding of medical affairsand how evidence, scientific strategy and field medical connect to broader business priorities and patient impact across the product lifecycle., • Ability to interrogate evidence and translate it into strategy -connecting technical findings to clinical and commercial implications without losing rigour., • Demonstrated business development ability- building and sustaining senior client relationships and converting opportunities into growth., • Strong leadership and people-management skills,with a track record of managing and developing teams and direct reports., • Superior written and verbal communication,able to distil complex science and evidence into clear, credible, executive-ready narratives for cross-functional audiences. What We Offer • A competitive package and remuneration linked to performance, • A high-growth, entrepreneurial environment where you can create significant client and business value and forge your own path, • A platform for accelerated professional development and career growth with significant levels of responsibility and accountability, and the opportunity to be part of the US management team, • An opportunity to lead extraordinary teams that are driven by personal learning and client impact The annual full time base salary range for this role is ($140,000 - $165,000). Specific compensation is determined through interviews and a review of relevant education, experience, training, skills, geographic location and alignment with market data. Additionally, positions may be eligible to receive a discretionary bonus as determined by bonus program guidelines. Prescient offers PTO and paid holidays, the terms of which are set forth in the program policies. All full-time employees also are eligible to participate in various benefit plans, including medical, dental, vision, life, disability insurance and 401K; in each case in accordance with the terms of the applicable plans. We are an equal opportunity employer and fully comply with applicable legislation in all of the geographies in which we operate. Applicants are considered for positions without regard to veteran status, uniformed service member status, race, color, religion, sex, national origin, age, physical or mental disability, genetic information or any other category protected by applicable national, federal, state or local laws. Dont meet every job requirement? Thats okay! Our company is dedicated to building a diverse, inclusive and authentic workplace. If youre excited about this role, but your experience doesnt perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.

Job DescriptionBenefits: • 401(k), • Competitive salary, • Flexible schedule, • Opportunity for advancement, • Paid time off, • Training & development, • Wellness resources Job Title: Full Time Pharmacist MUST HAVE RETAIL EXPERIENCE Position Type: Full-Time (Immediate Joining Preferred and Available to work weekends) Job Description: Icare Pharmacy Plus is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly., • Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices., • Collaborative Care: Work with healthcare providers to manage and improve patient care., • Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock., • Insurance Processing: Handle insurance claims processing and reimbursement efficiently., • Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements: • Must Have: A valid state required pharmacist license, • Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: • Strong knowledge of federal and state pharmacy laws and regulations., • Proficiency with pharmacy management software systems., • Excellent communication and interpersonal skills., • Ability to work efficiently in a fast-paced environment., • Strong attention to detail and organizational skills., • Commitment to providing exceptional patient care. Preferred Qualifications: • Certification in Medication Therapy Management (MTM)., • Experience with inventory management and cost-saving measures., • Proven track record of effectively managing a pharmacy team. Benefits: • Performance-based bonus, • Competitive salary, • Paid time off, • Training and development opportunities, • Wellness resources Why Join Us: • Supportive Environment: Be part of a team that values and supports your contributions., • Growth Opportunities: Advance your career with opportunities for professional development., • Balanced Schedule: Maintain a healthy work-life balance with our balanced work schedules., • Competitive Packages: Benefit from competitive salary packages and growth opportunities. We look forward to reviewing your application. Icare Pharmacy Plus is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Electrical Factory Inspector (Remote/Travel) responsibilities include, but are not limited to, the following: • Support department objectives and company goals, • Be a team player, • Sustain a positive, enthusiastic and professional attitude at all times, • Accommodate requests with a smile and “let me see what I can do” attitude, • Adhere to manager directives, • Maintain a professional appearance and demeanor, • Arrive on time, properly dressed and prepared to work, • Perform all duties in a timely, accurate, honest and professional manner, • Communicate with customers professionally and in accordance with customer service standards, • Be respectful to others Primary Tasks/Responsibilities: • Surveillance inspections of factories to assure products remain in compliance with conditions of granted certification., • Other duties assigned by management.Qualifications Basic Minimum Education Qualifications: • Two-year college degree or four-year college degree required Basic Minimum Qualifications: • Knowledge of electronics, • Certification in Electronics, ideal but not required, • Willing to travel - This position requires 90% - 100% travel, • Able to rent a car, • Willing to work overtime and remote, • Cannot be on any no fly list, • Clean driver record, • Authorization to work in the United States indefinitely without restriction or sponsorship. The Ideal Candidates Possesses the Following: • Ability to maintain confidentially, • Needs to be receptive to and accepting guidance from others, • Ability to deal with difficult people and problems, • Able to work well in a team environment, • Able to work in a diverse group of people, • Attention to detail, • Ability to multi-task and prioritize assignments, • Professional appearance Physical Qualifications: • Able to sit or stand for long periods of time, • Able to lift up to 30 pounds Additional Information Position is full-time travel & hybrid, working Monday - Friday 8:00 am to 5:00 pm, with overtime as needed. • Compensation: $50,000 - $70,000, • Excellent full-time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match, • Paid vacation and holidays Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Job Description Datavant is the data collaboration platform trusted for healthcare. Guided by our mission to make the world's health data secure, accessible and actionable, we provide critical data solutions for organizations across the healthcare ecosystem - including providers, health plans, researchers, and life sciences companies. From fulfilling a single patient's request for their medical records to powering the AI revolution in healthcare, Datavanters are building the future of how data is connected and used to improve health. By joining Datavant today, you're stepping onto a driven and highly collaborative team that is passionate about creating transformative change in healthcare. What We're Looking For We are looking for an experienced Senior Strategic Engagement Lead who thrives in a fast-paced environment. Strategic Engagement is the value engine of Datavant Life Sciences. We are accountable for driving meaningful, measurable outcomes for our customers by aligning our products and services with their strategic objectives - maximizing value, accelerating time to patient and business impact, and fostering long-term, expansive relationships. As such, we need an experienced relationship management individual who can drive success for our customers. This role includes responsibilities for commercial outcomes (e.g., value realization, customer satisfaction, renewals, etc.) and post-sale activities (e.g., delivery, adoption, advocacy, retention, etc.). What You Will Do • Own account management and value management for a dedicated account portfolio of up to 15 accounts in our biopharma segment, with a special focus on end-to-end acceleration of value within your portfolio., • Lead with curiosity and dive deep into learning and understanding the goals and strategies of our customers and how our solutions and products support those goals, • Excel in advanced program management and decision-making, balancing thoughtful analysis with speed to execution, appropriately prioritizing, and knowing when and how to escalate complex edge cases effectively, • Influence future lifetime value through higher product adoption, customer satisfaction and overall health scores, • Thrive in a fast-paced, continuous improvement environment, embracing gray areas and ambiguity, while seeking to drive clarity and scalability for your customers and the business, • Work effectively with your cross-functional partners - surfacing insights that influence product and sales strategies across account teams for your portfolio accounts., • Take a self-service-first approach to problem solving and navigating questions internally and externally, • Be a proven communicator and presenter with a commitment to maintaining good internal and external relationships through passion, empathy, and hard work, • Help create a company-wide culture of customer-centricity What You Need to Succeed • 10+ years experience in healthcare technology and customer facing roles (required), • Proven ability to build deep, trust-based relationships with customer stakeholders, • Seasoned strategic program and project manager focused on connect the dots thinking that puts client value at the center of everything, • Skilled at expanding relationships beyond direct contacts through rapport-building, • Demonstrated ownership of complex, high-value customer accounts, • Strategic thinker who connects cross-customer trends to shape value propositions., • Effective and empathetic internal and external communication, • Previous experiencing working in one or more of the following areas (required):, • Experience working within RWD health analytic companies, CROs, or systems integrators in the healthcare sector, • Application of RWD and RWE in the pharmaceutical and life sciences space, • Understanding of drug development and/or clinical trials, • Living within commutable distance to our office in Boston, MA and able to commute to the office and to client sites periodically #LI-BC1 We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services. The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation. The estimated base salary range (not including variable pay) for this role is:$140,000—$175,000 USD To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion. This job is not eligible for employment sponsorship. Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here. Know Your Rights, explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way. Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here. Requests for reasonable accommodations will be reviewed on a case-by-case basis. For more information about how we collect and use your data, please review our Privacy Policy.

Job DescriptionQuality Control Analytical ScientistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a Senior Member of the team the QC Analytical Scientist will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle. • Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients., • Support routine GMP testing as assigned. Mentor and train team members, • Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements., • Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports., • Create validation project plan i.e., timelines and resources and provides status updates to management. Utilize statistical tools for evaluation of method validation and trending data., • Identify, evaluate, and implement continuous business process improvements., • Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS)., • Provide support during laboratory investigations., • Train QC personnel during method transfer and validation. Provide support during equipment qualification., • Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices., • Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures., • Indirectly may supervise cross functional teams including product development, QA, PMP, and Manufacturing.REQUIREMENT, • B.S Analytical Chemistry or other scientific field or MS/Ph.D. in Analytical Chemistry or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products., • 8-10 years of experience in the areas of method development, validation, and transfer., • Direct GMP Experience., • Proficiency in project management skills and tools., • Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc., • Extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs., • Strong Quality orientation with attention to detail required. Analytical and problem-solving skills required., • Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution., • Excellent presentation skills. Ability to communicate to upper management, across departments and within the immediate QC team., • Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction., • Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external., • Must be familiar with GMP lab environment and Aseptic techniques.Working EnvironmentMust have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays, or overtime and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facilityMay work with hazardous materials and chemicals 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 at any time with or without notice.

Job DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements, • Travel may be requiredREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease 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 at any time with or without notice.

Job Description Overview Are you looking for a career you can feel good about? We hire only those that strive to do their best. By joining our family, you'll receive the honor and recognition that comes with working for the industry's global leader in evidenced based rehabilitation. Who We Are: GEO provides complementary, turnkey solutions for numerous government partners worldwide across a spectrum of diversified correctional and community reentry services. From the development of state-of-the-art facilities and the provision of management services and evidence-based rehabilitation to the post-release reintegration and supervision of individuals in the community, GEO offers fully diversified, cost-effective services that deliver enhanced quality and improved outcomes. Why Work for GEO: • We believe that work is more than a place you go to every day. It is about being inspired and motivated to achieve extraordinary things., • Employee benefits play an important role in making The GEO Group a great place to work. At GEO, we believe in the three pillars of employee wellbeing: physical, emotional, and financial. With comprehensive benefits and competitive wages, we trust that you will find all the resources you need here to be successful. Responsibilities Summary: The Physician is the first point of contact for many detainees/inmates and as a result must be able to diagnose a wide range of illnesses and injuries. The primary care/internal medicine Physician is also responsible for managing the overall care of the patient and communicating with the specialist or specialists as needed. The Physician manages and evaluates the medical program activities based on industry standards and contractual obligations. This position also functions as liaison between correctional officials, public agencies, and the company. Implements all contractually required services. Primary Duties and Responsibilities: • The Physician examines and treats to ensure proper injury care, disease prevention, diagnosis, treatment and recovery on detainees/inmates referred by the nursing/professional staff under established clinical practice guidelines., • The Physician provides medical treatment and orders studies, tests and ancillary services required consistent with the provision of basic health care services., • Prescribes pharmaceuticals, other medications, and treatment regimens to treat identified and documented medical conditions and regularly reviews those cases requiring ongoing medical/pharmaceutical attention to include the administration and education of appropriate use of vaccines., • The Physician discusses potential side effects of medication/treatment with patients and ensure that all allergy information is up to date before prescribing medication/treatment., • Provides advice to patients for lifestyle and diet changes that may improve their health or help to treat the health issue they are experiencing., • The Physician produces clear and concise health records, reports and correspondence, including the use of Electronic Health Records system., • Maintains patient confidentiality and comply with all federal and state health information privacy laws., • The Physician collaborates and communicates effectively with the Hospital medical team, Psychiatric, Mental Health Professionals, Nurses, Health Technicians and Administrative Assistants., • The Physician maintains professional and technical knowledge by attending educational workshops/seminars/conferences, reviewing professional publications, establishing personal networks, and participating in professional societies, and completes required Continuing Medical Education requirements., • Maintains a professional appearance and demeanor., • The Physician provides 24-hour on-call coverage to advise nursing staff in the care of detainees., • Performs regular chart review for quality assurance purposes and countersigns telephone orders., • The Physician designates the level of care to be performed, and the necessary equipment needed. Identifies continuing care facilities and specialty physicians., • Initiates dental and psychiatric referrals., • The Physician participates in Mortality Reviews., • Reviews and responds to your Peer Reviews., • The Physician performs other various duties as assigned.

Job Description Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a energy and utility company in Newark, NJ. This is a Hybrid role see details below. This role will be onsite and available to candidates local to the Newark, NJ area. We are interested in every qualified candidate who is eligible to work in the United States. Unfortunately, we are not able to sponsor visas or employ corp-to-corp Business Development Manager - Energy Efficiency Program Support Manager Location: Hybrid – Newark, NJ - 1 day per week Supporting Clients in Central and South New Jersey 12 Month Contract Pay Rate: $60-$65/hr w2 Mileage Reimbursement Job Summary Oversee the performance of vendor(s), both office and field, that have been contracted to deliver program services Ensure vendor and employee compliance with safety protocols and practices Lead and participate in cross-functional teams, including other RES members, Customer Care, Contracting, Procurement, Legal, Marketing, IT etc, as required to deliver program services Enhance program delivery/customer experience and resolve business/customer issues Develop and maintain the processes for implementing energy efficiency projects and programs in accordance with requirements for BPU approved programs Provide oversight for business controls, process improvement and compliance Ensure accurate invoice processing Identify and implement process improvements and automate where possible Monitor program Key Performance Indicators to ensure program delivery meets business plan expectations Prepare and present program and project status reports to senior management Assist with special projects as necessary This leader must foster an inclusive work environment and respect all aspects of diversity. Must demonstrate and value differences in others' strengths, perspectives, approaches, and personal choices During storm restoration efforts, may be required to perform functions outside of routine duties and on a schedule that may be different from normal operation Job Responsibilities Oversee the performance of vendor(s), both office and field, that have been contracted to deliver program services; manage employee performance; ensure safety protocols and practices are followed. Lead and participate in cross-functional teams, including other RES members, Customer Care, Contracting, Procurement, Legal, Marketing, IT etc, as required to deliver program services, enhance program delivery/customer experience and resolve business issues. Develop and maintain program processes. Provide oversight for business controls, process improvement and compliance. Ensure accurate invoice processing. Identify and implement process improvements and automate where possible. Monitor program Key Performance Indicators to ensure program delivery meets business plan expectations and regulatory requirements; Prepare and present program and project status reports to senior management. Required: B.S. Degree in Management, Engineering, Business, Finance or other relevant field or equivalent work experience plus 7 years of experience in the space of energy efficiency programs, construction, or related fields. In lieu of a degree, 11 years of experience in the space of energy efficiency programs, construction, or related field. Experience managing vendor performance, and leading cross-functional teams; Energy Efficiency or Electric Vehicle program experience Management/leadership experience working with cross-functional teams Valid US driver's license Desired: Certified Energy Manager (CEM) certification MBA or Advanced Degree Company DescriptionA WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.A WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.

Job DescriptionAssociate Director, Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Operations is responsible for efficient utilization of Operations resources to meet customer demand. This role will be responsible for maintaining and overseeing the site Operations scheduling and training capacities for a time period looking ahead to the next 3-6 months. The Associate Director, Manufacturing Operations will understand upcoming needs and constraints and help drive strategy accordingly. This includes the management of all Operations scheduling, training and compliance resources. The Associate Director, Manufacturing Operations is also responsible for assessing the needs of the company to contribute to the big picture by ensuring daily operations run smoothly and as efficiently as possible. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meeting client process demands through planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contracts, • Looking out 3-6 months to ensure capacity and availability of resources (room/equipment/staff) to perform clinical manufacture for processing needs, • Manages all training and compliance activities in the Operations organization, • Responsible for creating, enforcing and measuring Operator training schedules in order to ensure that all production schedules can be carried out, • Creates and maintains a process to ensure that personnel schedules are being accurately and fairly assigned to all Associates, • Supporting and driving special long-term projects and identified and assigned by the PPU Head, • Responsible for creating maintaining and communicating all Operations based KPI’s, • Ensuring department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices, • Approving job specific curriculum for the training and professional development of department staff, • Responsible for streamlining the batch record review process, • Responsible to understand the profit and loss for the PPU’s as well as all related documentation, and how these items impact Operations, • Driving continuous improvement, • Liaison with support groups for short- and medium-term needs – Supply Chain, Training, Quality Systems, Quality Assurance, Quality Control, and others, • Set team expectations and goals and assists in delivering the business direction for the PPU, • Aligning departmental goals, processes and resource allocation with the organizational strategy, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Direct reports: Associate Manager Training, Associate Manager, Compliance, Scheduling Associate, Quality Engineer Associates. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. REQUIREMENTS, • Bachelor's degree (i.e. Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-10 years of cGMP environment, aseptic processing, mammalian cell culture, monoclonal antibody, cell processing, cryopreservation or similar experience., • 5-10 years of leadership experience or equivalent combination of experience., • Deep Understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (able to work with Microsoft Office and corporate scheduling system), • Competencies/Candidate Profile, • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Flexible and able to adapt to company growth and evolving responsibilities, • Accountability, integrity, and strong dedication to regulatory compliance, • Strong business and personnel management acumen, • Strong emotional intelligence, • Ability to think strategically and tactically (detail-oriented), • Strong analytical and problem-solving skills, • Strong written and verbal communication skills, • Drive to create and maintain order in a fluid, technically complex environment, • Continuous improvement mindset, • Ability to multi-task is essential, • Must have the ability to work in a team-oriented environment and with clients, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.Duties, responsibilities, and activities may change at any time with or without notice

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.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 at any time with or without notice.

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)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 at any time with or without notice.

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Summary: This position is responsible for supporting and maintaining the Quality Management System (QMS) for clinical research activities conducted in the U.S., including SOP lifecycle management, document management system administration, user access control, TMF support, and operational assistance for local staff. The role works closely with the Associate Director and collaborates with cross-functional teams in the U.S. and Japan Headquarters to ensure compliance with applicable regulations (FDA, ICH-GCP) and internal standards. Essential Duties and Responsibilities: SOP Management • Maintain and update SOPs and controlled documents in accordance with internal procedures and regulatory requirements., • Coordinate SOP revisions, reviews, approval workflows, and periodic updates., • Track and manage SOP training compliance for local staff/Expats. Document Management System Administration • Serve as system administrator for the Document Management System (e.g., user provisioning, access rights, permission changes, issue troubleshooting)., • Provide onboarding and ongoing training to users on document management processes and system usage., • Ensure compliance with established document governance standards. TMF (Trial Master File) Support • Provide operational support for TMF processes, including quality checks, filing accuracy, and document completeness., • Coordinate with CROs and internal teams to ensure TMF inspection readiness., • Assist in implementing TMF standards, filing plans, and quality review processes. Local Staff Operational Support • Act as a primary point of contact for U.S.-based team members for QMS- and documentation-related matters., • Provide guidance and troubleshooting on SOP interpretation, documentation workflows, and compliance expectations., • Support audits and inspections by preparing relevant documentation and coordinating responses. Cross-Functional & Global Collaboration • Collaborate with Japan Headquarters teams to ensure alignment of quality and documentation standards., • Participate in global or regional meetings related to QMS, SOPs, and document management., • Contribute to harmonization projects for global SOPs, templates, and processes. Future or Expanded Responsibilities (as organizational needs evolve) • Support clinical team regarding vendor oversight processes, including documentation tracking and compliance checks., • Provide operational support to study teams using Veeva applications (e.g., Vault, eTMF, Quality Docs), • Participate in broader Quality Management System initiatives as needed. Supervisory Responsibility • No direct reports; may guide junior staff or contractors. Qualifications: Required • Experience in clinical research, clinical operations, quality, or document management within the pharmaceutical/biotech/CRO industry., • Strong understanding of FDA regulations and ICH-GCP guidelines., • Hands-on experience with document management systems (eTMF, CTMS, DMS, or similar)., • Excellent communication skills and ability to work in a multicultural, global environment., • Strong organizational skills and ability to manage multiple priorities simultaneously., • Ability to proactively identify issues, propose solutions, and support continuous improvement. Preferred • Experience managing SOP lifecycle processes or QMS operations., • Knowledge of TMF structure, filing expectations, and inspection readiness., • Experience supporting audits/inspections., • Japanese language skills a plus (not required)., • Experience with Veeva Vault (eTMF, QualityDocs, or CTMS), • Experience supporting vendor management, Issue/Risk Management Education: • Bachelor’s degree in a life science, healthcare, or related field., • 3–5+ years of relevant industry experience. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $110,000 to $140,000 actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training, • Flexible Work Arrangement Programs Applications will be accepted until June 30, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The National Training Manager (NTM) supports a Brand or Franchise organization in the design and delivery of training solutions to a field sales organization. An NTM ensures both Training & Development and Brand Strategy is effectively represented in all training programs and solutions. This role is accountable to quickly build relationships with key stakeholders and manage several stakeholders at various levels. The role requires a high level of performance coaching, strategy alignment/execution, and application of training fundamentals to enhance performance learning of participants. Responsibilities • Designs, develops, and delivers compliant learning solutions that increases effectiveness and credibility of participants., • Builds trust and credibility with key stakeholders through regular interaction, evidenced by feedback and proven working partnerships., • Leverages existing Learning & Development core platforms and content within the specific Franchise/Brand training products, to limit duplicative efforts., • Demonstrates direct and open communication to key stakeholders resulting in positive relationships and mutual alignment., • Provides candid and specific verbal & written feedback to training participants resulting in their awareness of strengths and weaknesses including a plan for improved performance., • Provides coaching and feedback to National Field Trainers (NFT) across the organization to help them to be the best NFT they can be., • Recognizes the skill level of training participants and adjusts coaching and training techniques to meet the needs of individuals., • Develops Guest Trainers and/or Rotational Trainers by providing them a meaningful role in the class, one-to-one coaching including performance feedback., • Demonstrates and applies knowledge of all stakeholder businesses, strategies and priorities and integrates training activities into brand team business plans., • Leads cross-functional initiatives and may be responsible for additional special projects within training organization., • Recognized as a product and disease-state expert as well as an expert in non-therapeutic areas such as customer and business skills., • Assists with the on-boarding, development, and mentorship of other NFTs and “leads through teamwork” cultivating and maintaining positive peer-to-peer relationships., • Executes with little guidance and/or direction from senior leadership.Qualifications, • Bachelor’s degree, • 5+ years of field sales experience in pharmaceutical industry as an Account Executive or District Manager or 2+ years sales training experience, • Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. CFR 210/211, cGMP), • Prior experience leading projects with regional or national impact, • High performing sales track record and strong understanding of what drives success in a commercial organization Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionQuality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. • Develop and maintain training program within Quality Control which includes, onboarding and continuous training, • Manage deviations, CAPAs, change controls and document review to ensure compliance, • Ensure OOS investigations are completed adequately., • Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories, • Identify resources needed for training and compliance and build team accordingly, • Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements., • Monitor effectiveness of CAPAs, change control activities, and audit observation closure., • Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators, • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory experience in a cGMP environment a must, • 3-5 years’ experience in the pharmaceutical, biologics ore related industry, • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position, • Sound understanding of cGMPs, • Experience in laboratory training and compliance, • External laboratory management experience, • Strong knowledge of testing methodologies, philosophies, method validation and method transfers., • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Experience with laboratory training programs, • Knowledge of GMP requirements, • Excellent organizational and leadership skills, • Outstanding analytical problem-solving abilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. 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 at any time with or without notice.

Job DescriptionDescription: AAF International offers the most comprehensive clean air solutions available across the globe. Selling under the American Air Filter® and the AAF International® brand names, AAF International has been an industry pioneer since 1921 with manufacturing operations in 22 countries and over 6000 employees globally. Our products are the industry benchmarks for quality and performance. Our applications include commercial, industrial and residential solutions from the filters used in your home to the most critical cleanroom and power generation applications. We are a member of the Daikin Group, the world's largest air conditioning provider with $30 billion in revenue and over 98,000 employees worldwide. Founded in 1924, Daikin has grown into a diversified industrial manufacturing company offering solutions in clean, air, air conditioning, refrigeration, chemicals, oil hydraulics, defense systems and electronics. Our culture of continuous improvement, safety and world class operations is driven by our people-centered management philosophy. This philosophy is built around mutual selection: that while AAF seeks top talent people to join and deliver on our team, we also want each team member to receive job satisfaction, growth & development, and continued happiness in being a long-term member of the AAF family. This is fueled by our belief in treating our people, our supply partners, our customers and our environment with the trust and respect we each require, and our passion to give back to our community for our success. Read more about our philosophy at: http://www.daikin.com/about/corporate/philosophy/index.html AAF International is an Equal Opportunity Employer M/F/Disability/Veteran. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, sexual orientation, gender identity, national origin, citizenship, veteran status, uniform servicemember status, age, disability or any other legally recognized protected personal characteristics. Position Objective: This position will report to the regional branch in New Jersey and work out of their home, ideally located in the territory. The territory for this position covers Nassau and Suffolk counties and the outer boroughs of Queens, Brooklyn, Bronx and Staten Island. Achieves maximum sales profitability, growth and account penetration within an assigned territory and/or market segment by effectively selling the Company’s products. Contacts and secures current and new business accounts/customers. Key Accountabilities: • Promotes/sells/secures orders from existing and prospective customers through a relationship-based sales approach highlighting the advantages/value proposition., • Demonstrates products to existing and potential customers and assists them in selecting those best suited to their needs., • Manages sales goals - profit and budget expenses., • Establishes, develops and maintains business relationships with current customers and prospective customers in the assigned territory/market segment to maintain current and generate new business., • Researches sources for developing prospective customers and for information to determine their potential., • Develops clear and effective written proposals and quotations for current and prospective customers., • Expedites the resolution of customer problems and complaints., • Coordinates sales effort with marketing, sales management, accounting, logistics and technical services., • Analyzes the territory/market’s potential and determines the value of existing and prospective customers to the Company., • Creates and manages a customer value plan for existing customers highlighting sales profile, share and value opportunities., • Provides management with detailed information on customer needs, problems, interests, competitive activities, and potential for new products., • Stays current with product applications, technical services, market conditions, competitive activities, and marketing trends and activities., • Participates in trade shows and conventions as required., • Perform other related duties as assigned as required. Requirements: Position Requirements: • Bachelor’s degree from an accredited university in Business or related field preferred;, • 5+ years' prior selling experience;, • Understanding and experience with high value-added product selling, pricing, and negotiation;, • Experience selling to healthcare and pharmaceutical facilities a plus;, • Ability to communicate a technical concept or value added benefit to achieve buy-in from diverse teams to meet sales targets and profitability;, • A history of consistently delivering on expectations for growth and profitability must be demonstrated;, • A team player that possesses a natural way of influencing, both internally and externally;, • A self-starter with a creative eye to implement marketing and promotional campaigns designed to achieve specific growth objectives regionally and nationally;, • Must be proficient in Microsoft Office (Word, Excel, PowerPoint);, • SAP or CRM experience, Salesforce preferred.