- 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
- Aequor (Newbury Park, CA)
- …and develop solutions. Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and deliver training ... materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management & Systems documents Analysis of the existing… more
- Eisai, Inc (Nutley, NJ)
- …experience with/using the following (which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting ... aligns with infrastructure, security and/or corporate systems' roadmaps. Collaborate with global finance for the planning, approval and reporting of budgets and… more
- Merck & Co. (Rahway, NJ)
- …configuration for the SAP FI/CO modules.- This role reports to the Global Financial Business Management Director . Responsibilities: Leadership and Management: ... drive revenue and productivity, thereby advancing our company's contribution to global medical innovation.Enterprise IT (EIT) is an essential component of the… 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
- Merck & Co. (Rahway, NJ)
- …company, the successful applicant will play a critical role in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized ... initiatives.Responsibilities:Support the SRO Lead in the execution of extensive, global initiatives, ensuring the program objectives and timelines are consistently… 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 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
- Merck & Co. (Rahway, NJ)
- …of contractor-initiated investigations associated with deviations, negotiation of site and global Technical and Quality Agreements, maintenance and accuracy of the ... on a variety of Quality or compliance-related issues.Interprets complex regulatory requirements for various audiences, including source area management, and… 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
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain...and objectives related to Supply Chain activities.Work with the global and internal stakeholders to develop and optimize site… 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
- 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be ... statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate Vice President in… 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
- 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
