- George Washington University (Washington, DC)
- I. JOB OVERVIEW Job Description Summary: The Director , Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance ... oversight of the research radiation and laser safety programs. The Director , Regulatory Oversight works closely with Office of Research Integrity and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …serves as point of contact with external health authorities. This position provides oversight of regulatory activities, leads or directs complex regional and/or ... rare diseases and immune disorders.Summary This position is responsible for providing oversight of the preparation, alignment and formulation of strategy for US… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The CRA Oversight Associate Director plays an integral role in the strategic ... development, oversight , and execution of global monitoring conduct across the...the quality plan.Lead, participate, or support internal audit and regulatory inspection activities related to site monitoring and sponsor… more
- Merck & Co. (North Wales, PA)
- …selected individual will function with a high degree of independence and provide regulatory oversight for assigned products, in order to optimize label and ... Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is ... The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited to original NDA/BLA/MAA,IND/CTA,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager ... About the Department The Clinical, 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)
- …& Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development ... & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Eisai, Inc (NJ)
- …components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight ... If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and… more
- Merck & Co. (Rahway, NJ)
- …incumbent would be the key quality representative attending and contributing to oversight and business review meetings with our company and contractor personnel to ... long-standing or significant issues affecting quality and efficiency.Interprets complex regulatory requirements for various audiences, reviews draft policies and… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop… more
- Merck & Co. (Millsboro, DE)
- …Delaware seeks to add an Attending Veterinarian in the role of Associate Director .This position will have overall responsibility for oversight and administration ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...care and use of animals.Responsibilities also include training and oversight of the animal care staff, serving as a… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV activities for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth ... knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth ... knowledge of regulatory authority's requirements. Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide… more
- Eisai, Inc (Nutley, NJ)
- …components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the ... of clinical outsourcing marketplace and industry trends.Participate in supplier oversight and governance meetings and lead processes improvement initiatives as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has leadership and ... overall strategic oversight of study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position interacts ... most efficient or innovative study design by considering the regulatory agencies' requirements for the country and Regions the...preclinical through Phase 3 and 4.- CRO / Vendor Oversight : Participates in drafting request for proposal for CRO… more
