- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT)… more
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... corporate standards and policies and business objectives.Actively- participate in labeling and global regulatory team meetings to ensure support for anticipated… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Nutley, NJ)
- …Diagnostics Pathway Educational Campaign and TacticsDevelop, implement, and manage Global diagnostic pathway educational strategy, campaign, and tactics in concert ... with the Global Leqembi brand marketing team.Drive alignment between ...with cross-functional colleagues including Medical, Market Access, Legal, and Regulatory as required 2. Management of Diagnostic Company Partnership… more
- Merck & Co. (Millsboro, DE)
- …Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate Director .This position will have overall responsibility for oversight and ... DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (North Wales, PA)
- …with Hybrid work model (combination of in-office and work from home abilities).The- Associate Director , Digital & Omnichannel Innovation for US Oncology-focuses ... build partnerships and trust with Commercial Legal, Compliance, Privacy and Regulatory colleagues to effectively alleviate concerns and mitigate real/perceived risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... the data services they provide to support drug development processes and global submissions. This position provides expertise within Data Management by partnering… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... momentum, and an inspiring mission to achieve new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...responsibility to collaborate with, and support the head of Global QA strategy and operations. In this position, the… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionAbout Insmed Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. ... multiple Research groups. The role will provide scientific and strategic guidance to global project teams and will oversee the internal and CRO resources as they… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent. ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more