- Merck & Co. (Rahway, NJ)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... Job Description Job Description: - The drug development Project Manager is part...of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is ... rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordination and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC ... plan.- Represent CMC development project teams on cross-functional drug development project teams with a predominately operational focus; ensuring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the ... meeting or teleconferences with Health Authorities- Global BDO Strategy to Improve Drug Development : Primarily participates and may occasionally lead moderately… 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 ... implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …preferred Minimum of 8 years total pharmaceutical/related industry experience in drug development required Demonstrated knowledge of global regulatory ... meetings with regulatory agencies, including the FDA Experience with rare disease drug development , innovative trial design and/or expedited regulatory pathways,… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... Managers, Data Managers, Clinicians, vendors) to support the overall development strategyProficient in managing service agreements and vendor contracts.Where you… more
- Genmab (Plainsboro, NJ)
- …implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part ... AI and Digital Technologies at Genmab! With our rapid development and implementation, you'll have the chance to harness...Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products.… more
- Genmab (Plainsboro, NJ)
- …our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Genmab (Plainsboro, NJ)
- …to CPL in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the initial ... development and management of the trial budgetPlan, implement, and...next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody- drug conjugates. To help develop and deliver novel antibody… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate ... growing portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics and Vaccines External Capabilities Associate Director serves as the primary point of contact for all activities associated with ... outsourcing process development and manufacturing efforts from the research and ...and GMP manufacturing (including cell banks, virus seeds and drug substance) in close collaboration with our company's external… more
- Merck & Co. (Rahway, NJ)
- …and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, ... and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and… more
- Merck & Co. (Rahway, NJ)
- …of clinical medicine experience-Minimum of 1 year of industry experience in drug development or biomedical research experience in academia-Demonstrated record of ... radically changes the way we approach serious diseases. --The Director will report to an Associate Vice...medicines. Our Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will… more
- Merck & Co. (Rahway, NJ)
- …Supply Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business. The Program ... as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working independently, the Program Clinical Supplies Project Manager… more
- Merck & Co. (Rahway, NJ)
- …healthcare. The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics as well ... functional impactProactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with ... integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study… more
- Merck & Co. (Rahway, NJ)
- …DescriptionAs part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences ... biologics. CCFS supports various commercialization activities, second generation process development including process characterization, technology transfer to internal and… more
- Merck & Co. (Rahway, NJ)
- …and applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global ... pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications.-Developing clinical … more
