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Territory/Area – Northeast / New England Target cities within the territory include New York City, Boston, Waterbury, Albany, New Brunswick, and Providence. The New England territory includes Connecticut, Massachusetts, Rhode Island, and portions of New Jersey, New York, Vermont, and New Hampshire. The Rare Epilepsy Market Lead is a strategic, field-based leader and local market expert responsible for engaging with key epilepsy Centers of Excellence (COEs) and rare epilepsy HCP treaters to identify barriers to treatment and provide appropriate disease state education while serving as a trusted resource for healthcare professionals seeking information related to Onfi® (clobazam) and Sabril® (vigabatrin) consistent with applicable compliance requirements. Further, this role will be responsible for generating actionable insights, identifying local market opportunities, and compliant coordination with cross-functional stakeholders across Commercial, Medical, Advocacy, and Market Access as appropriate to strengthen disease awareness, patient understanding, and education across the ecosystem to advance Lundbeck’s mission to improve the lives of people living with rare and serious neurological conditions. PRIMARY DUTIES AND RESPONSIBILITIES • Serve as the primary local market expert, continuously assessing customer preferences and patient needs, treatment dynamics, access challenges, competitive activity, and emerging opportunities across the rare epilepsy ecosystem., • Develop and execute a comprehensive territory business plan aligned to national strategy while tailoring execution to local market dynamics., • Appropriately identify field-driven innovative solutions, including deployment models and executional plans based on local market dynamics, while maintaining alignment to BU strategies., • Provide appropriate education and educational resources on Developmental and Epileptic Encephalopathies (DEEs) and seizure disorders, including disease identification, patient journey, treatment considerations, and appropriate use of Onfi® and Sabril® when requested, • Bridge local insights and enterprise strategy by leveraging a deep understanding of local epilepsy COEs, and treatment ecosystems to inform appropriate coordinated account engagement, • Develop awareness of, and appropriately engage with, local and regional patient advocacy organizations to support disease education, community engagement, and patient-centric initiatives in a compliant manner, • Demonstrate intellectual curiosity and a continuous learning mindset to uncover the underlying drivers of market dynamics and customer behavior, • Develop integrated account strategies that leverage the appropriate expertise and resources across Lundbeck to address complex challenges, • Appropriately operate as part of broader cross-functional organization and with other internal stakeholders, to ensure customer interactions are coordinated, purposeful, and aligned with account priorities and patient needs and broader commercial strategy, • In the future, potential to be responsible for management of, and collaboration across, a field-based team, • Utilize business analytics and CRM tools to track territory activity, account insights, and progress against business objectives, • Foster teamwork and a collaborative culture, champion and role model our Lundbeck rare epilepsy ways of working by empowering team members, acting with urgency, and orchestrating our customer experience to benefit the rare epilepsy patients and families we serve, • Ability to understand sophisticated reimbursement and distribution processes in a complex coverage landscape. Anticipates and appropriately communicates coverage changes to stakeholders, • 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, • Accountability and adherence to corporate, FDA, and PDMA guidelines REQUIREMENTS • Bachelor’s degree from an accredited college or university, • 7+ years' experience in the pharmaceutical/biotech industry, • 3+ years of specialty sales experience in pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Demonstrated track record of performance in a complex, low-volume, high-science selling environment, • Ownership and accountability for the development and execution of fully integrated account plans, • Strong clinical and business acumen with the ability to engage credibly in scientific and medical discussions with specialist-level customers and key stakeholders across epilepsy centers, • Excellent communication, organizational, and cross-functional collaboration skills, • Strong understanding of patient and caregivers needs, purpose-driven with a demonstrated commitment to patient-centric engagement, • Demonstrated curiosity, adaptability and entrepreneurial mindset consistent with a lean, results-oriented commercial organization, • Self-directed with the ability to operate and thrive as an individual contributor with a mindset that embraces evolution & change, • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck, • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Must live within a state in the New England territory or be state adjacent., • The role is part of Lundbeck’s Vehicle Fleet Stipend Program and requires business use of a personal vehicle. More information on the stipend program can be found _ PREFERRED QUALIFICATIONS • 2+ years in neurology, rare disease, or specialty CNS, • Prior experience in the epilepsy or rare neurological disease space strongly preferred, including rare disease product launch experience, • Prior experience professionally engaging with epileptologists or pediatric neurologists, • Experience with REMS programs or restricted distribution models, • Proficiency in CRM platforms and Microsoft Office Suite, • Prior commercial or sales leadership experience, • Market access payer experience, • Experience supporting specialty pharmacy/specialty distribution products, • Familiarity with academic health systems and referral networks, • Preference that candidate lives within 100 miles of the territory boundaries TRAVEL • Willingness/Ability to travel up to 70% 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: $190,000 - $230,000 and eligibility for a sales incentive target of $55,000 and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and Vehicle Fleet Stipend. Additional benefits information can be found on our _. Applications accepted on an ongoing basis. #LI-GK 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 _.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The territory encompasses Albany & Upper Manhattan. Reporting to the Division Sales Manager Targeted Accounts, the Account Manager Targeted Accounts, will contribute to BeOne's overall sales objectives by performing assigned sales activities. The Account Manager Targeted Accounts will provide physicians, pharmacists, and healthcare professionals with products, services, and information that will enable them to prescribe BeOne's portfolio of products safely and effectively. The Account Manager Targeted Accounts will focus on strategic initiatives in high performing accounts to support the Hematology and Solid Tumor franchises (Hematology in the near term). The ideal candidate will be capable of managing territory and administrative requirements in an efficient manner and will achieve full compliance with drug laws and regulations when representing BeOne's products to health care providers. The ideal candidate should also demonstrate strength in the competencies of teamwork, entrepreneurial mindset, and driving for results. Essential Functions of the Job: • Promotes BeOne's Hematology and Solid Tumor (Hematology in the near term) products through calls on targeted physicians in the assigned territory. Will implement sales, marketing, and patient support programs to acquire and keep appropriate patients on BeOne Hematology and Solid Tumor products., • Trains and educates physician support staff on the proper use and handling of BeOne's Hematology and Solid Tumor products., • Ensures that healthcare professionals have realistic expectations concerning the use of BeOne's Hematology and Solid Tumor products with their patients., • Maintains communication and integrates activities, when appropriate, with BeOne's Market Access and Customer Enterprise teams. Will collaborate with Field Medical when appropriate., • Identifies customer prescribing trends and territory dynamics and ensures, through coordinated communication and planning, that appropriate people and resources are allocated to opportunities., • Successful completion of all clinical training, sales training and eLMS/Compliance Wire assignments., • Performs all administrative functions required of the position, including reporting call activity and entering customer / account information in the appropriate call reporting system in a timely manner, as well as submitting expenses and utilizing the corporate credit card., • Is compliant with applicable BeOne policies and procedures (e.g., healthcare compliance policy, adverse event reporting, travel and expense reporting)., • Assists in the identification and resolution of opportunities and challenges; communicates insights proactively to marketing and sales leadership., • Must be skilled in working in fast paced environments with shifting priorities. Required Experience: • This position requires a B.A. / B.S. with previous pharmaceutical sales experience preferred., • The ideal candidate should have 8 plus years' experience in pharmaceutical sales & sales management, with significant oncology experience., • Must have a self-starting, self-managing independent work style., • Dedicated to making customer service a priority., • Must be results oriented with a strategic focus on sales., • Experience in specialty sales, with an understanding of reimbursement, distribution, and managed care processes as well as an understanding of national/corporate accounts, managed markets, hospital markets, sites of care, IV medications, injectables, orals, Medicare Part D, etc., • Ability to measure and analyze key performance indicators (ROI and KPIs)., • Familiarity with CRM software and proven track record of use., • Ability to actively engage in developing new business., • Proven track record of resilience in the face of challenges Education & Experience Required: BA / BS Degree preferred or relevant experience Supervisory Responsibilities: N/A Computer Skills: Highly skilled in Word, Excel, and PowerPoint Other Qualifications: Expertise in conducting conversations with members of the customer base when stakes are high and opinions vary. Travel: Must be willing to travel over a relatively large geography which will include daily and overnight travel up to 50-75% Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. • Fosters Teamwork, • Provides and Solicits Honest and Actionable Feedback, • Self-Awareness, • Acts Inclusively, • Demonstrates Initiative, • Entrepreneurial Mindset, • Continuous Learning, • Embraces Change, • Results-Oriented, • Analytical Thinking/Data Analysis, • Financial Excellence, • Communicates with Clarity Salary Range: $170,200.00 - $215,200.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

TECH LEAD VEEVA VAULT DEVELOPER Location: Remote | Type: Contract About Newpage Solutions Newpage Solutions is a global digital health innovation company helping people live longer, healthier lives. We partner with life sciences organisations which include, pharmaceutical, biotech and healthcare leaders, to build transformative AI and data driven technologies addressing real-world health challenges. From strategy and research to UX design and agile development, we deliver and validate impactful solutions using lean, human-centered practices. We are proud to be a ‘Great Place to Work®’ certified company for the last three consecutive years. We also hold a top Glassdoor rating and are named among the "Top 50 Most Promising Healthcare Solution Providers" by CIOReview. As an organisation, we foster creativity, continuous learning and inclusivity, creating an environment where bold ideas thrive and make a measurable difference in people’s lives. Your Mission The Veeva Vault Tech lead Developer plays a key role in configuring Vault components, developing targeted customizations, and enabling integrations that streamline content review, approval, and compliance across global markets. What You’ll Do • Lead Veeva Vault technical delivery, providing hands-on configuration, solution design, and technical direction across enhancements, integrations, releases, and support., • Translate business requirements into scalable Vault configurations and technical solution designs, providing feasibility, estimation, and delivery guidance., • Develop custom functionality using the Veeva Vault Java SDK where configuration is insufficient, and guide coding standards and best practices., • Build, support, and troubleshoot integrations using Vault APIs and ensure reliable data flows across connected systems., • Manage configuration migrations, deployments, release readiness, and version control across sandbox through production environments., • Support testing, defect triage, release execution, and post-deployment hyper care for escalated Vault issues., • Mentor developers and collaborate with QA, business stakeholders, delivery leads, and vendor partners throughout the delivery lifecycle. What You Bring • 10+ years of overall experience in Veeva Vault configuration and delivery, with strong senior-level expertise across objects, workflows, lifecycles, access, permissions, DAC, and security models., • Hands-on experience developing custom logic using the Veeva Vault Java SDK., • Working knowledge of Vault APIs, integrations, data flows, and troubleshooting., • Experience with Vault configuration migration, deployment, release management, and production readiness., • Familiarity with regulated content platforms such as PromoMats, MedComms, RIM, or QMS preferred., • Experience leading technical delivery in Agile, cross-functional, onshore/offshore team environments, with 2–3 years of experience in a Technical Lead or Team Lead capacity., • Strong problem-solving, communication, stakeholder-management, and mentoring skills. What We Offer At Newpage, we’re building a company that works smart and grows with agility, where driven individuals come together to do work that matters. We offer: • A people-first culture - Supportive peers, open communication and a strong sense of belonging, • Smart, purposeful collaboration - Work with talented colleagues to create technologies that solve meaningful business challenges, • Balance that lasts - We respect your time and support a healthy integration of work and life, • Room to grow - Opportunities for learning, leadership and career development, shaped around you, • Meaningful rewards - Competitive compensation that recognises both contribution and potential Ready to Apply? Let’s build the future of health together. Apply below or reach out to:

The Opportunity We are seeking a Director Government Pricing to lead and oversee government pricing activities across the US market. This is a highly visible role responsible for ensuring the accuracy, integrity, and compliance of government pricing calculations, while acting as the internal subject matter expert on pricing methodologies and regulatory requirements. A key focus of the role will be providing in-house expertise to review and validate government pricing calculations produced by external vendors, ensuring compliance with evolving federal regulations and minimising organisational risk. Key Responsibilities • Serve as the internal subject matter expert for US Government Pricing programs., • Lead the review, validation, and approval of government pricing calculations prepared by third-party vendors., • Own the calculation and oversight of Average Sales Price (ASP), ensuring timely and accurate CMS submissions., • Provide technical expertise across government pricing methodologies including AMP, Best Price, ASP, Medicaid Drug Rebate Program (MDRP), 340B, and Federal Supply Schedule (FSS) where applicable., • Ensure full compliance with CMS, Medicaid, Medicare, and other federal pricing regulations., • Develop, maintain, and continuously improve government pricing policies, controls, and standard operating procedures., • Partner closely with Market Access, Finance, Trade, Commercial Operations, Legal, Compliance, and external consultants to support pricing governance., • Support internal and external audits by maintaining robust documentation and responding to regulatory inquiries. Required Experience • Bachelor's degree in Finance, Accounting, Business, Economics, Life Sciences, or a related discipline., • 8+ years of progressive Government Pricing experience within the pharmaceutical or biotechnology industry., • Demonstrated expertise calculating and reviewing Average Sales Price (ASP)., • Strong knowledge of AMP, Best Price, Medicaid Drug Rebate Program, Medicare, and broader US Government Pricing regulations., • Experience overseeing or auditing third-party government pricing vendors., • Deep understanding of pricing compliance, governance, and internal controls.

Senior Clinical Trial Manager · Home-based within the United States; East Coast preferred · Minimum 5 years of clinical trial management experience; 8+ years preferred · Minimum 3 years of sponsor-side oversight of CRO operations on EU studies · Oncology or hematology clinical trial experience strongly preferred · Daily early-morning availability for collaboration with EU teams and sites Newave Pharmaceutical Inc. (Newave) is looking to hire a full-time Senior Clinical Trial Manager in the United States (remote, work from home). Newave Pharmaceutical Inc. is a commercial-stage biotechnology company headquartered in Pleasanton, California, focused on developing innovative small-molecule therapies in hematological malignancies and autoimmune diseases. Description SCHEDULE: Full-time Work Location: **This is a work-from-home position, and candidates may be located anywhere in the United States. East Coast candidates are preferred to support daily collaboration with EU sites, the CRO, and global internal functions. Duties • Provide day-to-day management of the CRO's EU operations, including performance monitoring, issue escalation, and participation in governance and operational meetings, • Lead EU site start-up activities, including site budget and contract review and negotiation, informed consent form review and approval, and review and approval of submission documents, • Monitor site performance, activation, enrollment, patient retention, and data quality across EU investigational sites in compliance with applicable EU regulations and ICH-GCP, • Prepare and maintain the EU portion of the quarterly study budget forecast for integration into global Phase 3 whole-study budget planning; track actuals against forecast and explain variances, • Review and validate CRO and vendor invoices and support Finance with reconciliation for the EU portion of the study, • Partner with the EU regulatory team and internal medical team on submissions and approvals to prevent country and site activation from being delayed by regulatory timelines, • Author and review clinical trial documents, including protocols and amendments, informed consent forms, site-facing materials, and IRB/EC and health authority correspondence; coordinate review and approval through internal & external document repositories and assist oversight of eTMF filing, • Maintain and review EU-specific trial and vendor documentation to support ongoing inspection readiness, • Work closely with global Clinical Operations, Data Management, Regulatory, Finance, CMC, Medical, and the CRO on both EU-specific and global study deliverables, • Develop and maintain operational plans, timelines, status reports, risk logs, and mitigation actions, and communicate material issues and decisions promptly, • Perform other duties as required to support successful delivery of the global Phase 3 program Qualifications You should have: • Bachelor's degree in life sciences, medicine, pharmacy, or a related field, • Minimum 5 years of clinical trial management experience; 8 or more years preferred, • At least 3 years of sponsor-side experience overseeing CRO operations on EU clinical studies, • Oncology or hematology clinical trial experience strongly preferred, • Working knowledge of applicable EU clinical trial regulations, ICH/GCP guidelines, and EU data protection requirements, • Demonstrated experience with CRO oversight, site start-up and contracts, site performance oversight, budget forecasting, invoice review, and regulatory coordination, • Experience authoring, reviewing, and managing clinical trial documents and maintaining eTMF inspection readiness, • Availability for daily early-morning collaboration with the EU CRO team and EU sites, plus occasional late-day U.S. Pacific calls with the global team, • Strong leadership, communication, problem-solving, organizational, and cross-functional collaboration skills, • Ability to work effectively in a fast-paced biotechnology company, respond to issues promptly, and contribute towards global decisions under the advisor role, • Ability to travel as needed It would be helpful if you had: • An advanced degree in life sciences, medicine, pharmacy, or a related field, • Working knowledge of one or more European languages, • Prior CRA experience, • Experience mentoring and/or training less senior clinical operations team members We would love to talk to you about this opportunity. If you are highly qualified, you will hear from one of our recruiters. We are actively interviewing, so apply today. We are an equal opportunity employer and value diversity at our company. We do not discriminate based on any legally protected characteristic. Notice Our Company's recruiters take the candidate experience very seriously. During recruitment, no recruiter or employee will request financial or personal information by email. Our recruiters will not email you from a public webmail service such as Gmail or Yahoo Mail.

Managing Consultant - Pharmacovigilance and/or Regulatory Labeling Life sciences – US (Remote Opportunity) Navitas Life Sciences is a global consulting and services organization operating in the life sciences sector. Our clients are leading life science organizations including those working in Pharmaceutical, Biotechnology, Consumer Health, Medical Devices, and Dietary Supplements. Growing demand requires the continuing expansion of our consulting team. Our current assignments focus on enhancing performance in a range of regulated business activities, including: • Patient Safety and Pharmacovigilance, • Labeling and Regulatory Affairs, • Medical Governance, Quality and Compliance About the Role We are looking for a Managing Consultant with a track record of previous consulting experience in Regulatory affairs labeling projects and Pharmacovigilance/Safety to independently (a) lead work streams or subprojects to assess the client’s current Labeling/ PV management process, governance and technologies, (b) build suitable client solutions and (c) ensure effective implementation of developed solutions. Requirement: Lead a portfolio of complex consulting assignments to deliver innovative client solutions • Lead the project delivery, multiple and /or complex projects, act as prime client contact, • Provide leadership, bring insight and gravitas to the analysis, design and implementation of projects, • Build executive level client and stakeholder relationships across projects and accounts, • Oversee effective project budgeting and financial controls to ensure profitability Provide thought leadership across Labelling/RA and/or PV solutions and services • Bring latest thinking and insight to develop industry-leading RA / / PV / Labeling solutions, • Lead working groups, forums discussions and content development to support our industry networks, • Build industry presence, networks and drive business development, • Develop collateral for projects/domain areas e.g. author case studies, white papers, new concepts Be an integral part of the consulting leadership of NLS to build and grow the business • Conduct business development activities tovv drive growth – build relationships, conduct meetings, build proposals, close successful negotiations to secure project and account expansion, • Lead and coach direct reports and project teams, • Lead strategic themes, internal projects and/or business improvement initiatives, • Lead company meeting sessions, enthusiastically acts as a role model The successful candidate will preferably have experience in: At least 8 years+ consulting expeirence - a blend of operating model, process and tehcnology conulting experience. Proven Management consulting skills to include: • Program and Project management, • Process design analysis, design, implementation, • Business transformation / change management, • Governance and organizational design, • Technology landscape assessment / implementation, • Evidence of success with consulting methodologies, • Preferred experience in a regulatory or labeling role. Subject Matter Expertise in Regulatory Labeling and or PV Contextual understanding and experience in LS regulatory and/or PV Track record in driving growth. Digitally savvy, thirst to grow and succeed in an entrepreneurial environment WHY NAVITAS INC? here are many reasons why you would choose to continue your career at Navitas Life Sciences Great benefits, ample opportunities for growth and development, international opportunities, the chance to work on incredible projects with the best and brightest people, and more. Note: Navitas is hiring for Management consultant role for both Regulatory Labelling and Pharmacovigilance vertical for US and UK Location. What you see is a consolidated Job description. Please ask for the individual JD when you apply for the role. Strictly no agencies please ** Job offer is subjected to successful interview completion and background check verification. Interested candidate: Please send your profiles to

The Associate Clinical Study Manager (ACSM) supports the planning, execution, and oversight of clinical trials to ensure studies are conducted in compliance with study protocols, company SOPs, and regulatory requirements. This role works closely with cross-functional teams, clinical sites, and vendors to ensure high-quality clinical trial delivery aligned with timelines and budgets. Key Responsibilities Clinical Trial Execution • Support the Clinical Study Manager in planning, implementing, and managing clinical trials., • Study start-up activities including site selection, feasibility assessments, and site initiation., • Track study progress, including patient enrollment, milestones, and timelines., • Monitor study performance metrics and escalate risks or delays. Site & Vendor Management • Serve as a point of contact for Clinical Research Associates (CRAs) and investigative sites., • Support management of contract research organizations (CROs), central labs, and other vendors., • Track vendor deliverables and ensure services meet study requirements. Study Documentation & Compliance • Maintain and review essential study documentation within the Trial Master File (TMF)., • Ensure compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs., • Assist in preparing documentation for regulatory submissions and audits. Cross-Functional Collaboration • Coordinate with internal teams such as Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs., • Support preparation for investigator meetings and study team meetings., • Provide status updates and reports to internal stakeholders. Risk & Issue Management • Identify study risks and assist in developing mitigation strategies., • Track protocol deviations, study issues, and corrective actions., • Support inspection readiness for regulatory authorities. Qualifications Education • Bachelor’s degree in life sciences, nursing, pharmacy, or related scientific discipline. Experience • 3–5 years of experience in clinical research, typically as:, • Clinical Research Associate (CRA), • Clinical Trial Associate (CTA), • Clinical Project Coordinator, • Experience working in biotechnology, pharmaceutical companies, or CROs. Skills • Strong knowledge of clinical trial processes and GCP regulations., • Experience with clinical trial management systems (CTMS) and electronic Trial Master File (eTMF) systems., • Strong organizational, project coordination, and communication skills., • Ability to manage multiple priorities in a fast-paced biotech environment.

Location: Home Based, USA Travel: Up to 75% by car and air Build and Support Radiopharmaceutical Facilities That Make a Difference Jubilant Radiopharmacies is seeking a Specialist, Facilities to coordinate equipment and facility projects across our U.S. network. This opportunity is ideal for a hands-on facilities professional who can manage complex projects, build strong vendor partnerships, and keep safety, quality, and compliance at the center of every decision. You will support facility openings, relocations, renovations, restorations, and closures. Your responsibilities will include planning and coordinating the purchase, delivery, installation, relocation, and decommissioning of laboratory, office, and IT equipment. Role Overview As the Specialist, Facilities, you will manage equipment-related projects from planning through completion. You will work closely with internal teams, site leaders, contractors, vendors, and service providers to help ensure projects are completed safely, on schedule, and within budget. This is a home-based position in the United States with frequent travel to company locations. Key Responsibilities • Manage equipment-related facility projects from planning through completion., • Develop project scopes, schedules, budgets, and cost estimates., • Coordinate equipment procurement, delivery, installation, relocation, assembly, disassembly, modification, commissioning, removal, and storage., • Lead contractors, vendors, service providers, and cross-functional project teams., • Coordinate equipment decommissioning with Operations, Quality, Radiation Safety, and Environmental Health & Safety stakeholders., • Support cleanroom projects, facility upgrades, and operational improvements., • Identify cost-saving opportunities and help standardize equipment solutions across the network., • Partner with Supply Chain on pricing, volume purchasing agreements, and custom equipment solutions., • Work with site leaders to reduce operational disruption during relocations and facility projects., • Create purchase requisitions, monitor project spending, process invoices through SAP ERP, and maintain accurate project documentation., • Ensure projects comply with applicable Quality, Safety, regulatory, and company requirements., • Complete other duties and special projects as assigned. Qualifications • Bachelor's degree in Facilities Management, Engineering, Construction Management, Project Management, Operations Management, Business Administration, or a related technical field, • required. Equivalent combination of education and relevant experience may be considered., • 5+ years of experience in regulated pharmaceutical manufacturing environments, or facility maintenance., • Demonstrated experience with facility systems, including mechanical/HVAC, electrical, plumbing, and general infrastructure components such as carpentry., • Working knowledge of NRC/state radiation control requirements, and cleanroom standards., • Knowledge of USP , USP , USP , pharmacy regulations, and quality systems is preferred., • Experience supporting cleanrooms and/or classified production environments is preferred., • Understanding of radiation safety, radioactive waste handling is preferred., • Certified Facility Manager (CFM) or equivalent is desired., • Radiation Safety, OSHA, and/or EHS certifications are desired., • Working knowledge of project management, budget management, vendor coordination, facilities operations, and regulatory compliance., • Proficiency in, or the ability to quickly learn, SAP, Concur, Microsoft 365, including Word, Excel, and Teams, and other required software., • Strong communication, collaboration, accountability, and problem-solving skills., • Ability to travel frequently, up to 75%, by car and air. What We Offer We offer competitive compensation, an annual performance bonus, generous vacation, and 401K matching. Our Commitment to Inclusion Jubilant Radiopharmacies is committed to providing an inclusive workplace where people are treated with dignity and respect. We consider qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law.

Director, Pharmacovigilance & Safety Operations Full-Time / Remote position Position Overview A growing clinical-stage biotechnology company is seeking a Director to lead global drug safety operations and establish the systems, processes, and infrastructure needed to support an expanding oncology pipeline. This individual will play a central role in ensuring patient safety and regulatory compliance as the organization advances a global Phase 3 clinical program and prepares for future development milestones. This is a hands-on leadership role combining pharmacovigilance operations, safety systems management, regulatory reporting, risk assessment, and vendor oversight. The successful candidate will be responsible for the effectiveness of the company's PV operating model, including the technology and processes used to capture, evaluate, reconcile, track, and report safety information. The Director will partner with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, Quality, and senior leadership to maintain a robust global safety infrastructure. The ideal candidate has experience in a small or midsize biopharmaceutical environment, is comfortable working across both strategic and technical areas, and can build scalable processes without losing sight of day-to-day execution. Key Responsibilities Pharmacovigilance Operations & Regulatory Reporting • Direct global drug safety operations across clinical development programs, ensuring the accurate and timely handling of adverse event information and compliance with applicable reporting requirements., • Oversee individual case safety report (ICSR) workflows, including intake, triage, case processing, medical review, quality control, follow-up, and expedited reporting., • Manage the preparation, review, and submission of periodic and aggregate safety reports, including DSURs, PSURs/PBRERs, and other applicable regulatory safety documents., • Establish reliable processes for reconciling safety information between the safety database, clinical trial systems, and other relevant data sources., • Monitor reporting timelines, data quality, compliance metrics, and operational performance; identify issues and implement corrective actions., • Support the development and maintenance of safety content for Investigator's Brochures, clinical protocols, informed consent documents, clinical study reports, and regulatory submissions. Safety Systems, Argus & Data Integration • Own the operational effectiveness and ongoing development of the company's pharmacovigilance technology environment, with particular emphasis on Oracle Argus Safety or comparable safety databases., • Lead or oversee safety database configuration, implementation, upgrades, validation, user acceptance testing (UAT), change control, and system maintenance in collaboration with IT and external vendors., • Ensure safety systems are appropriately configured to support case workflows, regulatory reporting rules, business processes, and global compliance requirements., • Oversee interfaces and data exchange between safety databases, electronic data capture (EDC) platforms, clinical trial management systems, and other relevant applications., • Lead reconciliation and integration initiatives to improve data consistency, traceability, reporting accuracy, and operational efficiency across systems., • Establish system requirements, user specifications, testing protocols, validation documentation, and controlled procedures in accordance with applicable regulatory expectations., • Manage system-related issue resolution, vendor performance, access controls, audit trails, and inspection-ready documentation., • Identify opportunities to streamline manual processes, improve data visibility, and strengthen PV operations through better use of technology and automation. Signal Management & Benefit-Risk Assessment • Establish and maintain a structured approach to ongoing safety surveillance, signal detection, signal evaluation, and escalation of emerging safety concerns., • Coordinate reviews of cumulative safety data, relevant scientific literature, and other available sources to identify potential changes in a product's safety profile., • Lead or coordinate benefit-risk evaluations and ensure safety findings are appropriately documented and communicated to relevant stakeholders., • Oversee risk management activities and the development or maintenance of risk management plans and other risk-minimization measures, as applicable., • Partner with clinical and medical experts to evaluate emerging safety issues and determine appropriate follow-up, investigation, and reporting actions., • Support internal safety review meetings and independent safety committees by providing accurate safety data, analyses, and operational coordination. CRO, Vendor & Partner Management • Select, manage, and oversee external pharmacovigilance service providers, including CROs, case-processing vendors, and safety technology providers., • Define service expectations, quality standards, deliverables, and performance metrics; monitor adherence to contractual and regulatory requirements., • Maintain and oversee Safety Data Exchange Agreements (SDEAs) and other agreements governing safety responsibilities with partners and collaborators., • Review vendor outputs, resolve quality or compliance issues, and implement process improvements where needed., • Ensure outsourced activities remain appropriately supervised and that responsibilities are clearly defined between the company and its service providers., • Coordinate audit preparation, inspection readiness, and follow-up of findings related to PV processes, systems, and external partners. Function Development & Cross-Functional Leadership • Build and refine the PV operating model, establishing the infrastructure and capabilities required to support the company's evolving clinical portfolio., • Develop and maintain SOPs, work instructions, policies, quality controls, and documentation standards across safety operations and systems., • Serve as the primary internal resource for PV operational questions, providing practical guidance to teams across Clinical Development, Clinical Operations, Regulatory Affairs, Quality, and Data Management., • Partner with senior leadership to prioritize resources, manage the PV budget, and determine the appropriate balance between internal capabilities and outsourced services., • Establish clear ownership, escalation pathways, and governance processes for safety-related decisions and deliverables., • Mentor colleagues and support the growth of the PV function as organizational needs expand. Required Qualifications • Approximately 5 to 8+ years of progressive pharmacovigilance or drug safety experience, including meaningful responsibility for PV operations, systems, or functional leadership., • Experience supporting clinical-stage drug development within a biotechnology or pharmaceutical company, preferably in an environment with lean internal teams and outsourced service providers., • Demonstrated knowledge of global safety reporting requirements and applicable FDA, EMA, ICH, and GVP standards., • Experience overseeing ICSR processing and review, expedited reporting, aggregate safety reporting, and ongoing safety surveillance., • Practical experience with pharmacovigilance safety databases, particularly Oracle Argus Safety or ARISg., • Experience with safety system implementation, configuration, validation, UAT, upgrades, workflow development, or related technical operations., • Understanding of safety data reconciliation and the interfaces between PV systems and clinical databases, including EDC platforms., • Experience managing CROs, safety vendors, or other outsourced PV activities, with accountability for quality, timelines, and compliance., • Ability to establish procedures, improve workflows, investigate operational issues, and maintain inspection-ready documentation., • Strong organizational, analytical, and communication skills, with the ability to work independently and collaborate effectively across technical and scientific teams. Preferred Qualifications • Experience building, restructuring, or scaling a pharmacovigilance function at a clinical-stage or emerging biotechnology company., • Experience supporting global Phase 3 clinical trials and late-stage development programs., • Oncology drug development experience, ideally involving targeted therapies or small-molecule therapeutics., • Familiarity with kinase inhibitors and the RAS/RAF/MEK pathway is advantageous., • Experience supporting NDA or BLA submissions and associated safety documentation., • Experience with global safety system integrations, database migrations, automation, or process optimization initiatives., • Experience with signal detection tools, regulatory intelligence platforms, or safety data analytics., • Familiarity with EU Qualified Person for Pharmacovigilance (QPPV) responsibilities or global PV governance., • Experience managing external safety partnerships and negotiating or maintaining SDEAs. Work Environment & Opportunity • Fully remote opportunity., • Direct access to senior leadership and cross-functional decision-makers., • Opportunity to shape the company's PV infrastructure, technology environment, and operating processes., • A hands-on role with meaningful ownership as the clinical pipeline advances., • Competitive compensation, equity participation, and comprehensive benefits. #LI-CA1 Pharmacovigilance | Drug Safety Operations | Argus Safety | Clinical Development

Our client is looking for a Group Art Supervisor position, supporting ongoing creative development for a Type 1 Diabetes brand within the pharmaceutical industry. This role involves providing creative leadership and hands-on involvement in developing promotional materials, supporting brand initiatives, and ensuring compliance with regulatory standards. This role is a 100% remote, 2 month contract. The application deadline for this role is 10/27/2026. Group Art Supervisor Responsibilities: • Lead creative development across integrated pharmaceutical marketing initiatives., • Guide visual execution of HCP and patient-facing promotional materials., • Partner with account, strategy, medical, and copy teams to deliver effective creative solutions., • Present concepts and creative rationale to internal stakeholders and clients., • Support brand evolution through messaging updates and campaign extensions. Group Art Supervisor Qualifications: • 7-10 years of pharmaceutical or healthcare agency experience., • Strong portfolio demonstrating leadership of integrated healthcare campaigns., • Advanced proficiency in Figma and Adobe Creative Suite., • Experience directing concept development across print, digital, and video channels., • Experience leading multidisciplinary creative teams and mentoring junior talent., • Ideally have experience supporting a type 1 Diabetes brand Perks and Benefits: • Medical, Dental, and Vision Insurance., • Life Insurance., • 401(k) Program., • Commuter Benefit., • eLearning and Ongoing Training., • Education Reimbursement. Eligibility requires working over 30 hours per week on an assignment lasting at least 10 weeks. If you meet the qualifications and are excited about this opportunity, apply today! Our team will connect with you to discuss next steps, support you through the interview process, and advocate for your success.

We are HCLTech, one of the fastest-growing large tech companies in the world and home to 219,000+ people across 54 countries, supercharging progress through industry-leading capabilities centered around Digital, Engineering and Cloud. The driving force behind that work, our people, are diverse, creative, and passionate, raising the bar for excellence on a regular basis. We, in turn, work hard to bring out the best in them as we strive to help them find their spark and become the best version of themselves that they can be. Job Title: AI Product Manager – Biopharma Location: [US – New Jersey] Employment Type: Full-time Department: Product Management / Life Sciences Solutions 📝 Job Summary: We are seeking a dynamic and experienced AI Product Manager – Biopharma to lead the strategy, planning, and execution of innovative products that serve the pharmaceutical, biotechnology. This individual will drive product lifecycle management from ideation to commercialization, ensuring the delivery of compliant, high-impact solutions that support R&D, clinical development, regulatory, and post-market needs. Candidates should bring strong techno-functional expertise, digital product acumen, and the ability to bridge scientific insight with commercial value. 🧠 Key Responsibilities: 1. Product Strategy & Vision • Define and own the product vision, strategy, and roadmap for Biopharma offerings (drug development, clinical trials, regulatory, pharmacovigilance, commercial), • Conduct market research, customer interviews, and competitive analysis to inform feature prioritization and differentiation. 1. Product Lifecycle Management • Manage the full product lifecycle from ideation, MVP development, pilot testing, global rollout, to post-market updates and sunsetting., • Lead cross-functional teams through Agile development cycles to deliver high-quality, timely product releases. 1. Stakeholder Collaboration • Act as the key interface between engineering, scientific SMEs, marketing, regulatory affairs, and sales., • Collaborate with external partners, CROs, regulatory bodies, and key opinion leaders to refine product features and ensure compliance. 1. Innovation & Digital Transformation • Drive the integration of emerging technologies such as Gen AI, NLP, RWD/RWE platforms, and cloud-based systems into life sciences workflows., • Partner with AI/ML teams to conceptualize smart, compliant features for medical content generation, adverse event detection, clinical data analysis, and signal management. 1. Go-to-Market & Commercialization • Develop product launch plans, including value propositions, pricing, positioning, and user training., • Support pre-sales and customer success teams with product demos, documentation, and RFP responses. 📋 Required Qualifications: Education: • Bachelor’s degree in Life Sciences (Pharmacy, Biology, Biotechnology, or equivalent)., • Advanced degree (MS, PhD, or MBA) is a plus. Experience: • 10+ years of experience in product management within the life sciences, pharmaceutical, biotechnology, or medical devices industry., • Demonstrated experience launching B2B SaaS, clinical, regulatory, or pharmacovigilance, payers and providers products in regulated environments., • Prior involvement in global product rollouts across multiple markets. Domain Expertise: • Strong understanding of clinical trial processes, drug safety, regulatory compliance (GxP, FDA, EMA, ISO 13485), and R&D lifecycle., • Experience with HealthTech, MedTech, Genomics, or Real World Evidence (RWE) is highly desirable. Technical & Tools: • Familiarity with AI/ML applications in life sciences is a strong advantage., • Developed AI based products and solutions, expertise in Gen AI and agentic AI, • Proficiency with product management tools (JIRA, Aha!, Confluence), wireframing (Figma, Balsamiq), and analytics dashboards., • Experience working with cloud (GCP, AWS, Azure), API integrations, and GxP-compliant systems. ✅ Preferred Competencies: • Strategic thinking with strong analytical and decision-making skills., • Excellent communication, storytelling, and stakeholder management abilities., • Strong organizational skills and a results-oriented mindset., • Comfortable navigating ambiguity in highly regulated industries., • Experience working with global teams across time zones. 🎯 KPIs & Success Metrics: • Time-to-market for new product/features., • Product adoption and customer satisfaction (NPS, CSAT)., • Revenue growth and market share contribution., • Compliance and regulatory approval success rates. Equality & Opportunity for All Representing 165 nationalities across the globe, we pride ourselves on being an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law.

Build your future at Curia, where our work has the power to save lives. The Maintenance Technician performs modifications and repairs to facility, properties, equipment and furniture, and assists in the maintenance and upkeep of the general facility, including custodial functions. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives. We proudly offer: • Generous benefit options (eligible first day of employment), • Paid training, vacation and holidays (vacation accrual begins on first day of employment), • Career advancement opportunities, • Education reimbursement, • 401K program with matching contributions, • Learning platform, • And more! Responsibilities: • Responsible for facility modifications and repair, encompassing electrical, plumbing, painting and light construction. Assures that these functions are performed in compliance with workplace safety procedures, OSHA requirements, and all applicable federal, state and local regulations, to the extent that the employee is aware of from discussions with the supervisor and training received, • Maintain a working understanding of plant production processes, equipment, systems, and facilities in order to perform maintenance effectively, under general direction, • Interact with, monitor and assist outside contractors and vendors in conjunction with their projects, • Perform scheduled maintenance on equipment and facilities in accordance with the company's Maintenance Schedule and SOPs, • Use machine tools, hand tools, and other tools of the trade to work with a variety of materials within prescribed tolerances, as directed, • Locate, relocate, assemble and install equipment and furniture as needed or requested, • Perform custodial functions including, maintenance of the floors, rugs, bathrooms and overall facility appearance as needed and/or directed, • Recommend and implement methods to increase the quality of products and/or services, • Participates in self-development activities and training of others, • Complete the Facilities Personnel Core Competency in the Learning Management System, • Exhibits safety awareness and safe work practices, • Performs other related duties as may be reasonably assigned in the course of business or as requested by supervisor or management Required: • Associate's Degree in an electrical or mechanical discipline preferred, or appropriate trade certification and at least 2 years of experience in maintenance and/or machine repair, • Must possess good written and verbal communication skills and be able to coordinate several diverse responsibilities, • Chemical Hygiene Training Other Qualifications: • Must pass a background check, • Must pass a drug screen, • May be required to pass Occupational Health Screening, • May be required to obtain and maintain gowning certification, • May be required to obtain and maintain media qualification Pay Range: $24.05/hour. Education, experience, location and tenure may be considered along with internal equity when job offers are extended. All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

Job-ID: 2005007Category: Information TechnologyLocation: Albany, NY, United StatesSchedule: Full timePosted: 2026-10-22Shift: DayRelocation Eligibility: YesQuality Requisition: NoVault Access: TBDJob Description: CSV Systems Engineer II/III in Albany, NYLevel will be dependent upon experience Build your future at Curia, where our work has the power to save lives. The CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the necessary tools to provide quality metrics, measurements, and reports for internal audits and inspections. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.We Proudly OfferGenerous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment)Career advancement opportunities Education reimbursement401K program with matching contributionsLearning platformAnd more!ResponsibilitiesComputer Systems ValidationManage multiple site and global CSV projects at any timeMaintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issuesCreate all CSV deliverables for all CSV projectsProvide expertise in SOP generation and CSV processOwn general configuration modification to any CSV system based on CSV compliance standardsProvide expertise on creation of CSV execution templatesPerform CSV risk assessmentsQuality ManagementOwn CSV change records, CAPAs and Quality events for the CSV projectsAct as CSV reviewer on any CSV defects/deviations within any projectSupport Site and global CSV actions from any auditsParticipate in all site audits/inspections as CSV subject matter expertProvide guidance and resolution on quality issues that affect the integrity of the data or the systemInventory ManagementGather inventory and maintain all scientific applications and computer systems within Curia sites (GMP and non-GMP)Inform Service Engineer I of any changes in software and hardware statusIT ComplianceSupport Lab Ops team to ensure all computer systems has up to date Antivirus softwareSupport Lab Ops team to ensure all computer systems have a backup software installationSupport Lab Ops team in updating computer systems that are running outdated Operating systemsPerform monthly patching auditing risk assessments with Lead CSV Compliance AnalystPeriodic internal audits and inspections readinessExecute periodic reviews and data collectionParticipate in all site audits /inspections as a CSV subject matter expertQuality metrics, measurement, and reportingProvide routine project status reportsProvide routine software and hardware inventory updatesProvide routine progress updates on SOPs and TemplatesProvide CAPA, QE and CR updates to compliance teamProvide routine audit observations and remediations RequiredBachelor’s Degree in Information Technology or related fieldMinimum 3 years’ experience in quality and computer systems validation and/or information technology PreferredExperience in the pharmaceutical industryPay Range: Education, experience, location and tenure may be considered along with internal equity when job offers are extended.We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Assurance Compliance Specialist to support our Fill Finish facility. In this role, the Quality Assurance Compliance Specialist ensures quality and compliance to cGMP's, internal, external, and international requirements with respect to changing control activities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where: • Location: Rensselaer, New York, United States, • Work model: Monday-Friday, 8:00 AM - 5:00 PM Discover your role: • Reviewing, assessing, editing, and approving change control documentation to ensure compliance with quality, regulatory and SOP requirements., • Facilitating cross functional meetings and providing guidance and consultation to change proposal owners, • Developing relationships with end users and providing advice on best practices in Change Control, • Partnering with other members of the Quality Assurance team and/or end users of the system to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process, and associated procedures, • Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures and documentation., • Supporting regulatory and customer audits., • Experience in change control function is strongly preferred. This role might be for you if: • Knowledgeable in Biotech/Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory., • Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another., • Ability to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment., • Proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure or plan., • Possess excellent interpersonal, written and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships., • Proficient digital literacy in Microsoft (MS) Word, Excel and PowerPoint required. Experience with Process Compliance/QUMAS heavily preferred. This role requires: Bachelors in a scientific or engineering discipline or related field with the following minimum amounts of relevant experience for each level, in a combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements. • Associate Specialist 0-2+ years, • Specialist 2-5+ years, • Senior Specialist 5+ years Level is determined based on qualifications relevant to the role. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process.

Build your future at Curia, where our work has the power to save lives. The Compliance Specialist II supports new products and existing product development by working to ensure compliance with cGMPs, company and customer quality standards as well as external regulatory requirements. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives. We proudly offer: • Generous benefit options (eligible first day of employment), • Paid training, vacation and holidays (vacation accrual begins on first day of employment), • Career advancement opportunities, • Education reimbursement, • 401K program with matching contributions, • Learning platform, • And more! Responsibilities: • Develop and maintain a strong command of SOPs, cGMPs and associated regulations. Apply this knowledge in the everyday work environment, providing consultation as necessary, • Develop an understanding of the function and basic operation of analytical equipment and techniques to enable effective performance of other duties, • Monitor compliance in the Analytical laboratories and actively participate in resolving quality issues, • Identify quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements, • Assist Analytical staff with change control and CAPA processes, writing deviations and investigations. Identify areas of concern and communicate to management, • Track and manage timelines for analytical quality events and initiatives. Coordinate efforts to ensure timelines are met and when necessary, assist staff with extension requests, • Coordinate periodic review and revision of SOPs, • Review and/or approve (where applicable) SOPs, material specification forms, test methods, instrument qualification protocols/reports, vendor repair/calibration reports, etc, • Assist Analytical staff with review and approval of equipment qualification documentation, including protocols and reports, • Assist Analytical staff with training programs for new hires as well as ongoing compliance awareness for the department, • Assist during regulatory, client, and internal audits including tours of Analytical laboratory areas, • Coordinate Analytical responses generated from regulatory, client, and internal audits. Engage relevant subject matter experts to assist with responses when necessary, • Perform all duties safely in accordance with Curia Safety Program, OSHA requirements, FDA regulations, and all applicable federal, state and local regulations, • Communicate within Analytical as well as with development chemists, Small Scale Manufacturing chemists, Quality/Regulatory personnel, Receiving personnel, maintenance and engineering personnel, information systems personnel and specific members of management (when requested), • Participate in self-development activities, • Exhibit safety awareness and safe work practices, • Perform other related duties as may be reasonably assigned in the course of business. Qualifications: • MS or BS Degree in technical discipline such as science or engineering or experience in a laboratory or chemical manufacturing environment. Will substitute relevant experience in lieu of educational requirements., • MS degree and minimum of one (1) year or BS degree and minimum of three (3) years of industrial cGMP experience in an FDA-regulated pharmaceutical environment. Will substitute relevant experience in lieu of educational requirements., • Proficiency in technical writing (e.g quality events, change controls, SOPs, protocols, reports, etc). Experience in Analytical instrument qualification and conducting investigations for Quality events is desirable., • Knowledge of FDA and ICH guidance for pharmaceuticals is required. Other Qualifications: • Must pass a background check, • Must pass a drug screen, • May be required to pass Occupational Health Screening Pay Range: $64,000-$79,600/yr. Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

Bachelor's degree in Chemistry or a related field with a minimum of three years of relevant industry experience;.Master's degree with at least one year of relevant experience.Experience working in a cGMP or GLP pharmaceutical industry environment.Review Quality Control testing for compliance with in

Job DescriptionPharmaceutical Sales Representative – Specialty & Entry Level We are a diverse and fast growing Biopharmaceutical company that is committed to focusing on patient health while delivering consistently high performance. Our Pharmaceutical Sales Rep team provides the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help our Pharmaceutical Sales Representatives set goals based on our organization’s potential and what we hope it will become. We are looking for a consistent and driven high performance with proven selling skills to join its innovative and skilled Pharmaceutical Sales Rep organization. Each Pharmaceutical Sales Rep will be responsible for establishing, promoting and maintaining a high level of sales. Our Pharmaceutical Sales Representative responsibilities: • Promote and sell products to current and potential customers within a defined geography., • Develop, analyze, prioritize and execute in order to execute territory plans to achieve business results through compliant means., • Uses functional and technical knowledge of pharmacology products, healthcare, pharmaceutical market places, managed care, and customer markets to meet or exceed customer needs. Understand and execute sales territory management and customer development., • Establish and maintain excellent communications and sound working relationships with physicians and healthcare providers., • Actively participate in scheduled Company sales meetings, district and regional conference calls and other business meetings., • Demonstrate honesty and integrity while modeling behaviors consistent with company standards and policies for business and compliance related matters., • Other related duties as required.The Pharmaceutical Sales Rep opening qualifications:, • Have some sales abilities or sales experience in quota driven role, • Some education and/or knowledge of pharmaceutical and healthcare products, • Demonstration of sustained, high performance in current position or a strong aptitude for learning, • High sense of urgency in particular with regards to customer service orientation, • Strong business acumen and ability to understand market opportunities, • Strong knowledge of the business and market in the assigned territory is preferred, • Ability to thrive in a highly driven culture that is performance based, fast paced, and results oriented, • Must maintain a high degree of integrity and be highly ethical at all timesPlease apply today for this opportunity. We are committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. EOE/AA. Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet Powered by JazzHR hvdc6R4Saz

Job Description Overview Who we are— Transcat is a dynamic, innovative, growing company that has been recognized as the leading calibration and compliance services provider in North America and beyond. With over 1,000 employees—in technical, consulting, operational, sales, finance, and corporate roles—we have stood the test of time by delivering on our Trust in Every Measure promise to our customers in vital industries, including life sciences, aerospace, defense, energy, and utilities. We fulfill this promise through our employees, who live Our Values every day, the Transcat Way. Our employees are at the center of the rewarding, challenging, and life-changing work we do for our customers and those they serve. Are you ready to join a company where the work you do makes a difference, and where you can grow in your career? Here’s what Transcat has to offer— • Work that matters., • A values-based culture where people care about each other and the work they do together., • Flexibility., • Training and development to accelerate learning and career advancement., • Competitive compensation and benefits, including paid time off, health insurance, tuition reimbursement, retirement, stock purchase plan, and MORE! We are Searching for— A full-time Associate Maintenance & Reliability (M&R) Engineer to support our client in Saratoga Springs, NY with the development and implementation of facility asset management and maintenance programs for a large life sciences manufacturing site. This is an onsite position reporting directly to the MARS Service Lead. This is a project-centered role with the first assigned project focused on supporting the development of accurate and complete maintenance and asset data within the client's Computerized Maintenance Management System (CMMS). The Associate M&R Engineer will work with facility equipment and infrastructure, performing field walkdowns, collecting and validating equipment data, reviewing equipment and vendor documentation, supporting asset hierarchy and master data development, and assisting with the creation of preventive maintenance records, work instructions, and other maintenance deliverables. The role will also support physical asset tagging and reconciliation activities and work closely with engineering, maintenance, and project teams to ensure facility assets are properly identified, documented, and prepared for ongoing maintenance and operation. Responsibilities Essential Duties and Responsibilities— • Support the development and implementation of asset management and maintenance programs for facility, utility, and infrastructure equipment, • Perform field walkdowns to identify equipment, collect nameplate information, and verify asset data against engineering and vendor documentation, • Review equipment documentation, OEM manuals, vendor turnover packages, drawings, and existing maintenance information to develop and validate asset records, • Create, update, and maintain equipment and asset master data within the client's Computerized Maintenance Management System (CMMS), • Support the development and maintenance of asset hierarchies, equipment relationships, and component-level records in accordance with established client standards, • Assist with the development of preventive maintenance (PM) records, work instructions, procedures, and other maintenance documentation, • Support physical asset tagging activities, including tag preparation, field installation, verification, and reconciliation of tagged equipment against CMMS records, • Review and validate equipment descriptions, manufacturer information, model numbers, serial numbers, technical specifications, and other required asset attributes, • Assist with the collection, organization, and attachment of equipment documentation to the appropriate asset records within the CMMS, • Support the development and maintenance of equipment Bills of Materials (BOMs) and spare parts relationships, as required, • Collaborate with maintenance, engineering, operations, construction, and project personnel to validate equipment information and maintenance requirements, • Identify data gaps, discrepancies, and missing equipment information and coordinate with the appropriate project stakeholders to resolve them, • Utilize Microsoft Excel and other data management tools to organize, analyze, validate, and report asset and maintenance information, • Maintain accurate documentation and records in accordance with client naming conventions, data standards, procedures, and quality requirements, • Follow all applicable client safety requirements while performing equipment walkdowns and other onsite activities, • Assist with other maintenance, reliability, and asset management activities as assigned Qualifications Required Knowledge, Skills and Abilities: • Ability to learn how to interpret equipment drawings, OEM manuals, equipment lists, and Bills of Materials (BOMs), • Able to become familiar with equipment criticality and risk-based decision making for spare parts selection, • Strong organizational skills with exceptional attention to detail and data accuracy, • Ability to manage multiple priorities while maintaining high-quality documentation, • Strong written and verbal communication skills with the ability to collaborate across maintenance, engineering, procurement, and operations teams, • Proficient in Microsoft Office applications, particularly Microsoft Excel Preferred • Bachelor's or Associate degree in a STEM field or trade certification in mechanical, electrical, instrumentation, industrial technology, or a related discipline, • Experience in maintenance, reliability, storeroom, procurement, or spare parts management, • Experience working in a maintenance or technician role, • Experience working with Computerized Maintenance Management Systems (CMMS), such as SAP PM, Maximo, Infor EAM, or similar systems, • Experience supporting pharmaceutical, biotechnology, or other regulated manufacturing environments, • Experience working with spare parts optimization, inventory management, or CMMS master data, • Experience researching supplier information, obtaining quotations, and evaluating lead times, • Familiarity with maintenance and repair operations, including spare parts for Maintenance, Repair, and Operations (MRO), • Familiarity with SAP PM, IBM Maximo, or other enterprise asset management systems, • Certified Reliability Leader (CRL) or Certified Maintenance & Reliability Professional (CMRP) certification Pay Range: $64,000 - $90,000/ year If this sounds like you, apply today! Equal Opportunity and Non-Discrimination Transcat is an equal-opportunity employer and prohibits discrimination based on any protected status. As required by United States law, all qualified applicants will receive consideration for employment without regard to age, color, disability, genetic predisposition or carrier status, national origin, race, religion, sex (including pregnancy, sexual orientation, and gender identity), status as a protected veteran, or as a member of any other protected group or activity under federal, state, and local law. We will make reasonable accommodations for employees with disabilities to enable them to perform the essential functions of their position unless doing so poses an undue hardship to the company or a direct threat to health or safety. Contingencies All offers of employment are contingent upon successfully completing all pre-employment requirements, which include verification of identity and employment eligibility, and when applicable, a motor vehicle driving record report. Ind1

Hartmann Young in Albany, NY, is seeking a QC Compliance Lead to strengthen laboratory compliance, investigations and continuous improvement within a pharmaceutical manufacturing environment. You will lead root cause investigations, oversee QC activities and keep laboratory quality systems inspectio

Job Description Job Description: The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle. Responsibilities: • Lead and execute computer system validation (CSV) activities for GxP-regulated systems., • Develop and review validation deliverables including validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports., • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regulations., • Define and implement risk-based validation strategies for computerized systems., • Oversee validation of systems such as LIMS, ELN, MES, ERP, CDS, and laboratory systems., • Support system implementations, upgrades, and decommissioning activities from a validation perspective., • Collaborate with IT, QA, Engineering, and business stakeholders to ensure compliant system deployment., • Lead change control assessments and determine validation impact of system changes., • Ensure data integrity (ALCOA ) compliance across validated systems., • Support audits and regulatory inspections by providing validation documentation and system justification., • Mentor and guide junior CSV engineers and validation team members., • Drive continuous improvement of validation processes, templates, and standards., • Review vendor documentation and ensure systems meet regulatory expectations prior to deployment. Requirements:, • Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field., • 5 10 years of experience in Computer System Validation (CSV) or validation engineering., • Strong experience in GxP-regulated pharmaceutical, biotech, or medical device environments., • Hands-on experience with validation of LIMS, MES, ERP, or laboratory systems., • Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines., • Experience authoring and executing IQ/OQ/PQ protocols and validation documentation., • Strong understanding of risk-based validation and data integrity principles., • Experience supporting regulatory audits and inspections. Preferred Skills:, • Experience with systems such as LabWare, SAP, Oracle, Veeva, TrackWise, Empower., • Knowledge of cloud-based validation and SaaS systems., • Experience in data integrity remediation projects., • Strong technical writing and documentation skills., • Ability to lead cross-functional validation projects. Key Competencies:, • Strong leadership and SME-level expertise in CSV., • Excellent analytical and risk assessment skills., • Strong communication and stakeholder management., • Ability to manage multiple validation projects simultaneously., • High attention to detail and regulatory compliance mindset.

Job DescriptionJob Description: The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle. Responsibilities: • Lead and execute computer system validation (CSV) activities for GxP-regulated systems., • Develop and review validation deliverables including validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports., • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regulations., • Define and implement risk-based validation strategies for computerized systems., • Oversee validation of systems such as LIMS, ELN, MES, ERP, CDS, and laboratory systems., • Support system implementations, upgrades, and decommissioning activities from a validation perspective., • Collaborate with IT, QA, Engineering, and business stakeholders to ensure compliant system deployment., • Lead change control assessments and determine validation impact of system changes., • Ensure data integrity (ALCOA ) compliance across validated systems., • Support audits and regulatory inspections by providing validation documentation and system justification., • Mentor and guide junior CSV engineers and validation team members., • Drive continuous improvement of validation processes, templates, and standards., • Review vendor documentation and ensure systems meet regulatory expectations prior to deployment. Requirements:, • Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field., • 5–10 years of experience in Computer System Validation (CSV) or validation engineering., • Strong experience in GxP-regulated pharmaceutical, biotech, or medical device environments., • Hands-on experience with validation of LIMS, MES, ERP, or laboratory systems., • Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines., • Experience authoring and executing IQ/OQ/PQ protocols and validation documentation., • Strong understanding of risk-based validation and data integrity principles., • Experience supporting regulatory audits and inspections. Preferred Skills:, • Experience with systems such as LabWare, SAP, Oracle, Veeva, TrackWise, Empower., • Knowledge of cloud-based validation and SaaS systems., • Experience in data integrity remediation projects., • Strong technical writing and documentation skills., • Ability to lead cross-functional validation projects. Key Competencies:, • Strong leadership and SME-level expertise in CSV., • Excellent analytical and risk assessment skills., • Strong communication and stakeholder management., • Ability to manage multiple validation projects simultaneously., • High attention to detail and regulatory compliance mindset.

Job DescriptionCompany Description At Eurofins PSS, we work with leading international companies across the pharma, medical device, food, cosmetic & consumer products industries - who all trust us with their mission-critical testing. For 20 years, our international network of teams have served clients at their sites, across 20 countries. PSS® is part of Eurofins Scientific, an international life sciences company, providing a unique range of analytical testing services across multiple industries, through a network of over 950 laboratories in 60 countries, and c.a. 63,000 employees. Job Description The Analytical Day 1 Chemist supports clinical testing of pharmaceutical products and contributes to maintaining high-quality laboratory operations. Key responsibilities include: • Supporting clinical testing of pharmaceutical products, • Gathering, documenting, and reviewing analytical data and test results, • Ensuring test results comply with established standards and reporting quality anomalies, • Complying with all applicable regulatory and compliance requirements, • Completing test records and reviewing supporting documentation, • Calibrating instruments or verifying calibration prior to use, • Maintaining laboratory supplies and general lab organization, • Participating in required training activities, • Interacting with outside customers and internal functional teams, • Assisting with method qualification and validation as neededQualifications, • Bachelor’s degree in Chemistry with minimum 2 years of relevant industry experience, OR;, • Master's degree in Chemistry with relevant laboratory experience, • Experience with HPLC, LC-MS, and/or UV-Vis spectroscopy, • Authorization to work in the United States indefinitely without restriction or sponsorship Additional Information Position is full-time, schedule is 1st Shift, Monday - Friday | 8:00 AM - 4:30 PM. What we offer: • 401(k) with company match, • Paid vacation and holidays, • Yearly goal-based bonus & eligibility for merit-based increases, • Base pay is between $26.00-$30.00/hr. Pay is determined based on degree and years of relevant experience. Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Job Description Come join an exciting and innovative company that puts the “care” back in healthcare! At KabaFusion, our patients come from all walks of life and so do we. We hire GREAT people, period! Our culture celebrates and supports the differences that make us unique. Here, it doesn’t matter what your role is, your hard work and dedication is not only recognized but celebrated. Join us and find out why this is the place to excel and do your best work. About Us: What started as a single pharmacy in 2010 has grown into KabaFusion becoming the largest privately held home infusion company in the country. We have a national network of pharmacies and nursing offices strategically placed to service 40+ states. Couple that with over 30 years of combined experience and it’s no wonder why KabaFusion is the industry leader in home infusion. JOB SUMMARY: This position is responsible for supporting pharmacy operations by assisting pharmacists with prescription processing, sterile compounding, inventory management, quality assurance activities, and patient service functions in accordance with state and federal regulations, USP standards, and company policies. This role coordinates medication, supply, and equipment deliveries; maintains accurate patient, pharmacy, and quality records; and serves as a key point of contact for patients, caregivers, providers, and internal teams. The Pharmacy Technician also performs administrative and operational duties to ensure safe, efficient, and compliant delivery of home infusion pharmacy services. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1. Support pharmacists in coordinating daily pharmacy operations and workflow to ensure efficient, safe, and timely delivery of pharmacy services., 2. Perform prescription processing, order entry, and related documentation activities under the supervision of a licensed pharmacist., 3. Prepare and compound sterile medications and pharmaceutical products in compliance with applicable laws, USP standards, accreditation requirements, and company policies., 4. Maintain clean room environments, pharmacy equipment, and infusion devices to support regulatory compliance and patient safety., 5. Conduct and document quality assurance and quality control activities, ensuring adherence to organizational and regulatory standards., 6. Manage pharmacy inventory, including ordering, receiving, stocking, and monitoring medications, supplies, and equipment., 7. Coordinate patient medication, supply, and equipment refills, deliveries, and related service logistics to support continuity of care., 8. Maintain accurate and complete patient, pharmacy, and operational records within electronic information management systems., 9. Provide professional customer service by communicating with patients, caregivers, healthcare providers, referral sources, and internal departments, escalating clinical concerns as appropriate., 10. Support reimbursement and administrative processes by verifying required authorizations, maintaining documentation, and assisting with pharmacy records management., 11. Generate, distribute, and maintain operational, quality, and management reports while participating in performance improvement initiatives., 12. Provide administrative and cross-functional support to pharmacy leadership and other departments while completing required training, competencies, and assigned projects., 13. Other related duties as assigned by manager or designee. JOB REQUIREMENTS AND QUALIFICATIONS Education: • High school diploma or equivalent required. Certifications or Licenses: • Current and unrestricted pharmacy technician licensure, certification or registration where required by state law. If required by state law: o Pharmacy Technician Certification (CPhT) through the Pharmacy Technician Certification Board (PTCB) is acceptable; or o Eligibility to obtain within six (6) months of hire; this includes training permit. • Completion of sterile compounding training and competency assessments as required by company policy and regulatory standards, if required by state law. Experience • Knowledge of basic drug terminology, pharmaceutical calculations, drug use and aseptic technique., • Previous sterile compounding experience in a home infusion, hospital, or specialty pharmacy setting., • Knowledge of USP <797> and USP <800> standards and practices., • Minimum one (1) year of pharmacy technician experience preferred; home infusion, sterile compounding, or specialty pharmacy experience preferred., • Knowledge of pharmacy operations, medication preparation, inventory management, and pharmacy documentation practices., • Working knowledge of applicable state and federal pharmacy regulations and quality standards, • Proficient with pharmacy management systems, electronic medical records, and Microsoft Office applications. What we offer: • Competitive compensation, • Benefits start on your 1st day of employment, • 401k w 4% match – no waiting or vesting period, • PTO / Floating Holidays / Paid Holidays, • Company paid life insurance, short term disability, • Employee Assistance programs to help with mental health / wellness, • Learning & Development Programs, • Perks… includes discounts on travel, cell phone, clothing and more…, • Generous employee referral program To learn more about KabaFusion, please visit our careers page: https://www.kabafusion.com/careers/

Job DescriptionPossible 3 Month CTH | No Fees | Do Not Re-Post | Confidential Submit candidates under their legal name and use only * template. Role name: MES Project Manager Work Location: Albany, New York (Onsite) Start date: Immediate availability. Background check MANDATORY Request ID: I9T9DK MES Project Manager Strong MES background, specifically 5 7 years of MES experience. Technical/project leadership capability. Potentially temp-to-hire. Could work remotely with periodic onsite presence, ideally 2 3 days every other week. We are seeking an experienced MES Project Manager to lead Manufacturing Execution System (MES) initiatives across digital manufacturing programs. The ideal candidate will bring a strong MES background, combining technical expertise with project leadership capabilities to successfully drive MES deployments, enhancements, and business transformation initiatives in a GMP-regulated environment. Key Responsibilities Lead end-to-end MES projects, ensuring delivery of scope, schedule, budget, and quality objectives. Manage cross-functional teams including Manufacturing, Quality, Validation, Automation, IT, and external vendors. Drive project planning, risk management, stakeholder communication, and governance activities. Provide technical leadership and oversight for MES implementation, integration, and enhancement initiatives. Coordinate requirements, solution design, testing, deployment, and hypercare activities. Support digital manufacturing transformation programs and continuous improvement initiatives. Ensure compliance with GMP, GxP, Data Integrity, and validation requirements. Manage project reporting, status updates, issue resolution, and executive stakeholder communications. Required Skills & Experience 5 7 years of hands-on MES experience in pharmaceutical, biotechnology, or life sciences manufacturing environments. Proven experience leading MES implementation or upgrade projects. Strong understanding of MES platforms such as POMS, Client-X, PharmaSuite, Opcenter, or Syncade. Demonstrated technical and project leadership capabilities. Experience working with Electronic Batch Records (EBR), manufacturing workflows, and shop-floor systems. Knowledge of MES integrations with ERP, LIMS, Automation, SCADA, and related manufacturing systems. Strong stakeholder management, communication, and problem-solving skills. Experience working within regulated environments and managing system validation activities. Please add the below to the comment section: Legal Name: Current Location: (City, State & Zip Code): Home location: Relocate: Bill Rate: CTH After 3 Months: Travelling Availability: Availability to Start: Phone/Mobile Number: Email Address: Visa Type: Visa Expiration Date: Hiring Status: Are you working directly with the contractor s visa holder: If not indicate # of layers and names of the company: Indicate if the Candidate has worked in CG before and where: Ex-* Employee: LinkedIn Account: (If available) Vendor Point of Contact for Interview Scheduling: Contractor approved to share its resume to client: Skills summary: Resumes will be rejected for the following reasons: • Different formatINC, • Missing details in comments section, • Missing text box in the header, • Photo ID included containing personal information other than legal name and photo Soemia Pineda External Resource Manager (ERM) | SubCo Staffing Center * North America |Guatemala

Job Description Job Summary We are seeking an experienced MES Project Manager to lead end-to-end Manufacturing Execution System (MES) implementation, upgrade, and enhancement projects within pharmaceutical, biotechnology, or life sciences manufacturing environments. The ideal candidate will possess strong MES technical expertise, project management capabilities, and experience working in GMP-regulated environments. Roles and Responsibilities • Lead end-to-end MES implementation, upgrade, enhancement, and deployment projects across digital manufacturing programs., • Develop and manage project plans, timelines, budgets, resource allocation, deliverables, and risk mitigation strategies., • Coordinate cross-functional teams, including Manufacturing, Quality Assurance, Validation, Automation, IT, and external vendors., • Provide technical leadership for MES solution design, configuration, implementation, integration, testing, and deployment., • Manage Electronic Batch Records (EBR), electronic workflows, manufacturing processes, and shop-floor system requirements., • Oversee MES integration with ERP, LIMS, SCADA, automation platforms, and other manufacturing systems., • Coordinate requirements gathering, functional specifications, user acceptance testing (UAT), system testing, deployment, and hyper care support., • Ensure compliance with GMP, GxP, data integrity, and computer system validation (CSV) requirements throughout the project lifecycle., • Manage project risks, issues, dependencies, change requests, and escalation processes to ensure timely delivery., • Drive stakeholder communication, project governance, status reporting, executive updates, and vendor management., • Support digital manufacturing transformation initiatives, process optimization, and continuous improvement programs., • Ensure project documentation, validation deliverables, and quality records are completed in accordance with regulatory and organizational standards. Education & Experience, • Bachelor's degree in engineering, Computer Science, Information Technology, Pharmaceutical Sciences, Biotechnology, or a related field., • A master's degree in engineering, Project Management, Information Systems, or a related discipline is preferred., • 5 7 years of hands-on MES experience within pharmaceutical, biotechnology, life sciences, or other regulated manufacturing environments., • Proven experience leading MES implementation, upgrade, migration, or enhancement projects from initiation through deployment and post-go-live support., • Practical knowledge of GMP/GxP compliance, data integrity principles, computer system validation (CSV), and regulated system documentation., • Demonstrated experience in project planning, risk management, stakeholder engagement, vendor coordination, and cross-functional team leadership.

Job Description This role is located in Kingman, AZ Are you a passionate and dedicated pharmacist seeking a challenging opportunity to deliver exceptional patient care? Look no further! Join our team with an award-winning healthcare system and one of the most progressive healthcare centers in our region. Kingman Regional Medical Center (KRMC) is located in beautiful northwest Arizona. Experience the magic of Kingman's stunning Arizona sunsets and thrive in an outdoor enthusiast's dream destination with picturesque mountain ranges, nearby lakes, vibrant parks, and plenty of outdoor activity. Kingman is an incredible community to live, work, and play! Hours/Shift: Full Time/Rotating Position Purpose: The Inpatient Pharmacist ensures the safe, effective, and compliant use of medications by performing both clinical and distributive functions. Responsibilities include reviewing and verifying medication orders for appropriateness, supervising sterile and non-sterile compounding, conducting medication history reviews, and providing drug information and evidence-based recommendations to the care team. The pharmacist supports disease management, promotes medication adherence, and educates patients and caregivers. This role also coordinates workflow and staffing, supervises pharmacy personnel, maintains formulary and inventory, and ensures accurate preparation, dispensing, and documentation of medications in compliance with all regulatory and institutional requirements, while supporting overall department operations. The Department: Kingman Regional Medical Center (KRMC) is the sole community hospital. Our department encompasses over 60 employees to serve our population’s health. These are exciting, busy times in our Pharmacy as we provide a full suite of pharmacy care services from acute care and transitions into emergency services, ambulatory, home, and telehealth care areas. A solid infrastructure to support our pharmacy services is in place, with our current focus to optimize and integrate our services. These service focus areas include: Inpatient, Emergency Department pharmacist direct patient care, Care Transitions – medication reconciliation/meds to beds before hospital discharge, outpatient and specialty pharmacy drug distribution, 340B Program and financial integrity expansion, oncology clinical model expansion including oral chemotherapy and pharmacogenomics, PGY-1 Pharmacy Residency Program, Stewardship-Antimicrobial and Opioid, and expansion of our pharmacist collaborative practice model Disease Management Clinic. All our endeavors strive to provide the best possible pharmaceutical care to meet the needs of our community and organization. Here’s a link to a few documents for your review regarding our department and services: https://linktr.ee/krmcpharmacy Benefits: We offer you an excellent total compensation package, including a competitive salary, comprehensive benefits, and growth opportunities. We invest in you! • Relocation Assistance Available, • Health and Well-Being, • Medical, Dental, Vision, Employer Paid HSA for HDHP participants, Robust Wellness and Employee Assistance Program, Employer Paid Group Life, Short & Long-Term Disability, • Generous Retirement Leave Accruals and Cash Out Opportunities, • 403b Retirement Plan with Employer Contributions, • Employee Recognition Programs, Employee Discounts, and Employee Referral Bonus Program, • Employee Identity Theft Protection, • On-site daycare exclusive to our employees’ children of all ages, • Career Growth and Development, • Paid Continuing Education Conferences/Meetings, • Tuition Reimbursement/Scholarships for full-time employees, • As a not-for-profit organization, our employees who have qualified student loans may be eligible for the Public Service Loan Forgiveness program, • So much more! Qualifications: • Education: Graduate of an ACPE-accredited School of Pharmacy with a Pharmacy Doctorate Degree, • Licensure: Licensed in the State of Arizona or will consider candidates eligible for Arizona licensure Work Requirements: Must be able to distinguish color, sit approximately 37% of the time; stand 30%; walk 33%, and carry/lift 25 -75 pounds; Duties have possible, but not routine, potential for exposure to blood, body fluids or tissues, and exposure to chemicals, biological, and radioactive substances About Us: Kingman Regional Medical Center (KRMC) is the largest healthcare provider and the only remaining not-for-profit hospital in Mohave County, Arizona. As a 235-bed multi-campus healthcare system, our medical center includes more than 1,900 employees, 270 physicians/allied health professionals, and 150 volunteers. KRMC is recognized as an innovator in rural healthcare and teaching hospital. We provide a full continuum of highly technical and specialized medical services to meet the healthcare needs of our community. Year after year the Leapfrog Group has awarded KRMC an "A" Grade for Patient Safety. KRMC has been recognized by Becker's 2025 list as one of the "Top 100 Greatest Community Hospitals" for our dedication to clinical excellence. We strive to provide a culture of safety, integrity, teamwork, accountability, respect and appreciation through recognition, career growth, and employee celebrations throughout the year for all of our staff. Kingman Regional Medical Center is a great place to work. Come join our team! Kingman Healthcare, Inc. does not provide visa sponsorship for this role. Please do not apply for this role if at any time (now or in the future) you will need immigration support (i.e., H-1B, TN, STEM OPT Training Plans, etc.). #LI-JW1 #JW

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Being a Dasher with DoorDash gives yo