- Merck & Co. (Durham, NC)
- Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program. In this ... manufacturing excellence from development through commercialization. You'll partner across Quality , Regulatory, Technical, and Supply Chain teams-coaching, facilitating, and… more
- Merck & Co. (Ames, IA)
- …and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... qualification through ongoing training and continuing education programs.Coordinate with Site Quality leads on audit refusals and postponements. Lead project… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Quality & Process leads quality assurance and ... training, and data-driven optimization aligned with Insmed's strategic goals.The Associate Director , Patient Services Quality & Process is responsible for… more
- Merck & Co. (Rahway, NJ)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The ... and finalization, and feed to the Submissions Assembly team. The Business Operations Lead should be able to understand the various source area processes and apply… more
- Repligen (Waltham, MA)
- …contribution drives progress. Join us!About the RoleRepligen is seeking a hands-on, strategic Director of IT & OT Infrastructure to lead the design, ... to business strategy, while overseeing internal teams, MSPs, and vendors to ensure high- quality , secure, and reliable services.You will lead and develop a… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global regulatory ... development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical functions and will act… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Metabolism & Obesity will be responsible for overseeing and facilitating the research in metabolic diseases & obesity and ... data science, while focusing on uncovering novel biology that delivers high- quality drug discovery pipeline.-We are a research-driven biopharmaceutical company. -Our… more
- Insmed Incorporated (San Diego, CA)
- …of science, we're in. Are you?About the Role:We're looking for an Associate Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us ... what's possible for patients with serious diseases. Reporting to the Executive Director , Clinical Development, you will support and work predominately with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team ... GMA Oncology productsLeads the planning and execution to ensure high quality and timely delivery of scientific publicationsManages publication activities in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes Global Medical and ... systems globally. The ability to successfully participate in and lead cross-functional teams is a critical part of this...is a critical part of this role. The Executive Director has scientific and budgetary oversight for all outcomes… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic ... and governance, holding external partners to high standards of quality , cost control, and on-time deliverables. Serve as the...cost control, and on-time deliverables. Serve as the Operations Lead for clinical assets and associated studies. Step in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director , Clinical Operations (Asset Lead ) is fully informed of the overall ... Director can be an extension to the Asset Lead when needed and serve as an SME (Subject...providing innovative strategies to continuously improve Global Clinical Operations quality and metrics. IT will also include building and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our ... including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of design verification strategies, and… more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC...QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments,… more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:This is a REMOTE position. The Associate Director of Field Medical Excellence (FME) will implement field medical functional strategy ... to enable high- quality , impactful customer engagements with a consistent approach worldwide....customer engagements with a consistent approach worldwide. The Associate Director FME will also drive operational excellence across the… more
- Merck & Co. (Rahway, NJ)
- …oversee GMP environmental monitoring and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a ... formulations, and their processes for non-sterile and sterile products. The Director will also collaborate with Development Quality , Pharmaceutical Operations,… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Associate Director , US Field Medical Training will be responsible for implementing and delivering a ... plans, tools, and materials for the US Field Medical team. The Associate Director , US Field Medical Training will drive training in scientific expertise coupled with… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) ... standards.Addressing medical/clinical queries from health authorities. Leadership and Collaboration: Lead cross-functional teams in clinical development, medical affairs, and… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Partner Relations oversees key vendor partnerships that support ... service excellence, compliance, and alignment with Insmed's strategic goals.The Associate Director , Patient Services Partner Relations is responsible for leading and… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Director , Global Medical Training Strategy will be responsible for developing the strategic ... are met across all of Global Medical Affairs. The Director , Global Medical Training Strategy will ensure training plans...users on materials and update as needed.Training Sessions - Lead GMA wide training sessions on key data, competitors,… more
