- Catalent (Manassas, VA)
- …is counting on us. Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we ... Associate Director , Regulatory Affairs Position Summary: Catalent is a...through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The… more
- Merck & Co. (North Wales, PA)
- …and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the planning and ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including: study… more
- Tris Pharma (Monmouth Junction, NJ)
- …and team success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director , Drug Safety is responsible ... presentations, as applicable Actively participates in meetings with FDA and other Health Authorities, as required; Represents Drug Safety , establishes and… more
- Catalent (Harman, WV)
- …is counting on us. Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we ... Senior Director , Supply Chain Position Summary: The Senior ...through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.The Role:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … signal detection and evaluation, risk management, and post-marketing epidemiological safety studies required by Health Authorities for all Daiichi-Sankyo ... related Epidemiology needs.Guide organization on proper use of automated health care databases for drug safety -related Epidemiologic studies.Mentor junior… more
- Eisai, Inc (NJ)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... 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
- Eisai, Inc (Nutley, NJ)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of ... Associate Director .This position will have overall responsibility for oversight and...and animal husbandry program at our company's Millsboro Animal Health facilities. This role is highly compliance-driven in accordance… more
- Eisai, Inc (Nutley, NJ)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... following (which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting Regulatory processes such as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …patient safety , and regulatory compliance. Address recurring deviations and health authorities' observations as a priority. CAPA Management: Oversee the timely ... the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functional, holistic perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional ... study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative or IST… more
- Catalent (Philadelphia, PA)
- …South American, Japanese, and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function...in making a difference. Catalent is committed to the health and safety of its employees, visitors… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects ... point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory strategy… more
- Merck & Co. (Rahway, NJ)
- …to discover and develop innovative medicines that change the course of human health . In the RaDS value team, the Product organization is responsible for implementing ... support our organization's target and biomarker discovery, chemistry, Biologics, Vaccines, safety , and process and analytical R&D efforts. The ideal candidate will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewThe Director , Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and ... you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support ... of data for statistical analysis to obtain background rates) for development of safety documents (eg, RMP), support SMTs, SERM or other safety -related meetings… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support: ... reasonable cost. Identify/develop tools for efficient vendor management.- Global Health Authority Interaction / Negotiation: Reviews documents and responses… more
- Insmed Incorporated (Bridgewater, NJ)
- …external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non-clinical safety , contract research organizations etc.) to build and to ... and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our US… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant stakeholdersPartners with cross-functional leaders incl. from across RD, Safety , Tech/Supply and Commercial to coordinate SMEs and engagement activities ... college or university)Bachelor's Degree bachelor's degree in medicine, life sciences, health or related field requiredAdvanced degree Eg, Masters, Pharm.D., Ph.D.,… more
