- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… 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 ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent… more
- Merck & Co. (Rahway, NJ)
- …include, but are not limited to:Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to ... Job DescriptionOur Regulatory Affairs team bring new medical...for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Summary The Associate Director is responsible for developing RWE strategies for assigned product(s) and ... #IND123 #LI-Remote Eisai Salary Transparency Language:The base salary range for the Associate Director , Global RWE (Real World Evidence), Global Medical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position The Health Economics and Outcomes Research (HEOR) Strategy & Synthesis Associate Director , Cardiovascular (CV) will be part of the HEOR Evidence ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...by the RWE and modeling teams within CDSE. The Associate Director , HEOR Evidence Strategy & Synthesis… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Associate Director , Medical Operations, Innovation and Emerging Projects (AD, IEP) is a role within Global Medical and Value ... Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director , Medical Operations, Innovation and Emerging Projects… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionWe are currently recruiting for the position of Associate Director , US Oncology - Hematology Scientific Strategy. This talented individual will ... Build out a robust scientific leader (SL) engagement plan, coordinating with medical affairs , clinical research, and global marketing to provide a consistent One our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities ... and is also an integral member of the Medical Affairs Team. This position plays a key role in...data and promotional content within the assigned therapeutic area- Regulatory milestones, actions and guidance relevant to medical review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents ... under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and by tracking and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date ... 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… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and execute additional statistical analyses ... Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Pleasanton, CA, USA * Princeton, NJ, USA Req #374 Friday, June 28, 2024 Looking for a chance to make a ... and/or development regulatory activities under the direction of Regulatory Affairs management. The incumbent plans, directs and executes the regulatory… more
- Ascendis Pharma (Palo Alto, CA)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- Novo Nordisk (Princeton, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions +… more
