- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV ... of a quality strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... trial protocol development and reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for collection,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is a strategic leadership role within ... for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director , has primary responsibility for ... The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates.… more
- Legend Biotech USA, Inc. (Chicago, IL)
- Legend Biotech is seeking a Regional Key Customer Marketing (Central) Associate Director as part of the Commercial team based in (but not limited to) AZ, IL, or ... to the Commercial Leadership, in addition to home office-based colleagues in Marketing, Medical Affairs , Sales, and Market Access.The behaviors that are critical… more
- Genmab (NJ)
- …phases of development.Partners with key stakeholders within Global Development Operations (GDO), Medical Affairs , Medical , and/or CROs, to enable expedited, ... predictive delivery for all stages of global feasibility. Ensure standardization in use of data, tools and processes to inform risk-benefit decision making at TA, program and study levels.This position reports to our Princeton, NJ office and is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary information… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents supporting CDx… more
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