- Insmed Incorporated (Bridgewater, NJ)
- …required for the successful and timely completion of cross-functional plans. The Sr. Director of Program Management will utilize best-in-class program ... and associated functional plans. As a leader, the Sr. Director of Program Management will provide cross-functional... program management processes. Drive implementation of key program documentation - Target Product Profile Strategic… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical ... Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Global Vaccines Communications for the company's pneumococcal and pediatrics franchise will collaborate closely with ... programs in support of the US and global vaccines businesses.-The Associate Director will report to the Director , Global Vaccines Communications.Primary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation… more
- Merck & Co. (Rahway, NJ)
- …diverse and inclusive work environment.Knowledge, Duties & Responsibilities for the Director Include:Oral drug product development concepts, tools, and ... and scaling up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …growth objectives via bespoke, evidence-based M&A advisory services. Reporting into the Senior Medical Director , M&A Scientific Advisory, the Medical Director ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...key M&A focus areas. Relationships Position reports to the Senior Medical Director , M&A Scientific Advisory. Essential… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director...strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to… more
- Insmed Incorporated (Bridgewater, NJ)
- …the reinforcement and ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct ... New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of...the Brand team for Insmed's in-line rare disease respiratory product and will be responsible for the development and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Public Affairs, Commercial, Marketing, Finance, and Marketing. Relationships Reports to Senior Director , Market Access Channel Strategy. Interacts frequently in ... for helping people live better lives and our award-winning product pipeline can only be as effective as our...role is based in Plainsboro, NJ. The Position The Director Market Access Channel Strategy is part of a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Director , QA Operations as part of the Quality team based in Raritan, NJ. Role ... Overview The Director of Quality Operations , CAR-T is responsible for...Disposition activities , including incoming materials and final drug product , QA shop floor oversight of manufacturing operations, Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …POA session format and content Accountable for collaboration on customer-specific program development and execution to improve product access, reimbursement ... and product pull through. Understands ROI concepts to ensure program effectiveness Develops and maintains relationships with key customer executives Develops and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …products for aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy Interacts ... for helping people live better lives and our award-winning product pipeline can only be as effective as our...frequently in collaboration with internal management and senior level global stakeholders Interacts internally with Strategic Pricing… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... and compiling, trending and reporting key quality metrics for Senior Management review, and other quality system functions, as...and the release of drug substance and/or final drug product to support Phase I/II clinical trialsWork with clients… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to ... includes operations that support end-to-end GMP clinical supply manufacture and product /process development, as well as oversight of the Enterprise Resource Planning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the DAST Lead and ... on customer insights, external landscape, and internal information including overall product development plans. - Proactive planning for asset milestones to account… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …modifying them as appropriate to meet changing needs and requirements of each program .Track program scope, costs, expenses, and budgets against defined metrics ... Communicate and monitor budgets in partnership with the Finance Lead for each program .Provide complete tracking of all program phases and activities, including… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the DAST Lead and ... on customer insights, external landscape, and internal information including overall product development plans.- Proactive planning for asset milestones to account… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …representatives, act as QA point person for all GxP matters for the Global Program Head and the Global Program Team. Provide operational QA leadership for ... discussions.Support the Head of RD QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... and escalating quality concerns. Relationships This position reports to the Associate Director of GXP Oversight and/or Head of GXP Support. Multiple internal… more
