- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... BLA Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC… more
- Merck & Co. (Rahway, NJ)
- …Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, ... the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead...quality investigations and change management.Extensive knowledge and experience of drug product processing.Managing and developing team including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... to ensure high quality data. Work closely with internal statistical programmer. Drug Development Strategy: Provides input to multiple aspects of the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... activities; collaborates closely with data manager to ensure high quality data. Drug Development Strategy: Provides input to multiple aspects of the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to ... and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC development plan.-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications.Participate in global product team meetings (development ... for assigned project(s).Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting… more
- Merck & Co. (Rahway, NJ)
- …lifecycle and maintaining programs in harmony with the portfolio. In addition, the Associate Director will be expected to participate in development of tools ... Chemistry Manufacturing & Controls (CMC) and Clinical strategies.- Position Description/Summary: The Associate Director , Project Manager, is a core member of… more
- Tris Pharma (Monmouth Junction, NJ)
- …internal and external stakeholders spanning many departments across all stages of the product lifecycle. The Associate Director , Alliance Management will be ... have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director , Alliance Management.Tris Pharma has a long track record of… more
- Insmed Incorporated (San Diego, CA)
- …Executive Director of Program Management, the Associate Director , Program Management supports the cross-functional drug development and commercialization ... in accordance with the program strategy. In addition, the Associate Director of PM may be asked...completion of annual goals and input to the global product strategy Facilitates resource planning, financial, and capacity assessments… more
- Merck & Co. (Rahway, NJ)
- …and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, ... laboratory to commercial scale, step across boundaries and implement novel innovations during drug product development to enable best science at first filing for… more
- Insmed Incorporated (San Diego, CA)
- …Millennials™, and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as Associate Director of MSAT where you will support pipeline programs ... deviation resolution, process improvements and scientific expertise in the Drug Substance and Drug Product . Provides strong technical leadership to process… more
- Merck & Co. (Rahway, NJ)
- …and manufacturing to manage clinical development projects; and assist the Associate Vice-President/Vice-President and product development team lead in ensuring ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …whose responsibility it is to deliver a best-in-class high volume marketed CAR-T product . This effort is business critical and part of a multi-site global ... support of an expanding global manufacturing network for best-in-class CAR-T product .Work collaboratively with internal and external partners to drive global process… more
- Merck & Co. (Rahway, NJ)
- …but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide product regulatory strategy ... to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their… more
- Merck & Co. (Rahway, NJ)
- …include, but are not limited to:Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to ... world.Looking for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for development and implementation… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… more
- Eisai, Inc (Louisville, KY)
- …with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and ... and nurses, etc. learn about the efficacy and safety of Eisai's product (s) consistent with FDA approved label. Works with office management to provide… more
- Eisai, Inc (San Diego, CA)
- …with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and ... and nurses, etc. learn about the efficacy and safety of Eisai's product (s) consistent with FDA approved label. Works with office management to provide… more
- Genmab (Plainsboro, NJ)
- …(DS) and Pharmacovigilance (PV) Scientist to join the team in Princeton. As an Associate Director of Drug Safety and Pharmacovigilance Scientist, you will ... a highly skilled and international team. The position reports to the Director , Global Drug Safety & Pharmacovigilance, Scientist Lead. Responsibilities Perform… more
- Genmab (Plainsboro, NJ)
- …assigned Genmab products (mainly investigational) throughout their lifecycle. As our Associate Director , you must effectively interact cross-functionally at all ... and authentic is essential to fulfilling our purpose. The Drug Safety & Pharmacovigilance (GDS&PV) Physician role is a...as well as colleagues from other Genmab sites. As Associate Director , GDS&PV Physician, you will be… more
