- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and ... teams on strategies associated with Operational Excellence. The role also involves strategic partnering with Development Quality, Process Research & … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development , Research Development , Regulatory Affairs. Facilitate ... the development and management of DSI's local and global Strategic PV Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs)… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Program Manager will advance the purpose and aspiration of ... this role, the DSCS Digital Program Manager will provide strategic and tactical direction and partner with the DSCS...Process Research & Development , Analytical Research & Development , and Pharmaceutical Sciences & Clinical Supply.… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the ... the development of new compounds The Senior Clinical Director may: Oversee the Clinical...area of responsibility. To accomplish these goals, the Senior Clinical Director may: Author detailed development… more
- Merck & Co. (Rahway, NJ)
- …of clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... writing, and presentation skills.Education/ExperienceBachelor's Degree +9 years of pharmaceutical, clinical drug development , project management, and/or medical… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the ... to lead clinical programs across different diseases and supervise the clinical development team. This individual will be the primary point person… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing the ... relationships with the clinical vendors as well as coordinate and manage outsourcing...Managers, Data Managers, Clinicians, vendors) to support the overall development strategyProficient in managing service agreements and vendor contracts.Where… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- …interpretation of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct and indirect ... Job DescriptionPosition Description: Associate Director , Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are tracked and ensure implications are assessed and communicated on timely manner- Clinical Development Life Cycle Management Decision Support: Be the key point ... around rare diseases and immune disorders. Summary The Associate Director Global Oncology Strategic Planning provides ...launched brands. The role will be responsible for the development and maintenance of Short to Long Term Forecasts… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …therapy areas, public affairs, and legal/compliance. Relationship Reports to Executive Director - Medical Modernization & Strategic Partnership Engagement. Serve ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...prioritization of priority professional associations relative to Novo Nordisk strategic area of interest Development of … more
- Merck & Co. (Rahway, NJ)
- …out R&D activities partnering across the network to enable process and formulation development .- In this position the SMAR&D Director will set guidance, lead ... development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients,… more
- Merck & Co. (Rahway, NJ)
- … Development Team, Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides a solid ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...least 5 years global or US medical affairs or clinical development experience with proven track record… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance...For large or complex Phase 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Health Systems Oncology Medical Affairs Director (HSO MAD) is a therapeutic and disease expert who develops ongoing professional relationships ... HSO MAD provides accurate information across the full oncology product portfolio, clinical science, and quality management in a balanced and credible manner… more
- Merck & Co. (North Wales, PA)
- …promotional regulatory training and coaching to team membersContributes to the development of departmental strategic initiatives to drive effective, compliant ... Job DescriptionReports to the Director /Senior Director in the Office of...objectives and minimize regulatory risk-Provide regulatory consultation in the development and implementation of US marketing strategy and promotional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building for the future, creating a distinct ... with other relevant functional areas, help develop/ refine the strategic development plan for DCR-PHXC and other...groups and utilize novel and creative methods to resolve clinical development problems Work with the larger… more
- Merck & Co. (North Wales, PA)
- …cross-functionally across the US Market, Global Marketing/Access, Medical Affairs, and Clinical /Outcomes Research.Oversee the development and execution of payer ... Job DescriptionAs the Director of Payer Marketing, you will lead a...the payer and provider experience.Work closely with Medical Affairs, Clinical , Global Market Access, and Outcomes Research to identify… more
- Merck & Co. (Rahway, NJ)
- …driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report ... development with exposure to all stages and aspects of development (pre- clinical , clinical , and commercial)Strong influencing and communication… more
- Genmab (Plainsboro, NJ)
- …regulations and guidance as they relate to global labelingUnderstanding of clinical development of novel biologics products, preferably in oncologyExperience ... to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and… more
