- Eisai, Inc (NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company...profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company...want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with regulatory and company strategy.Act as the management representative for all key health authority inspections ( US FDA, EU EMEA, MHRA etc.,).Develop and ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the...with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in… more
- Catalent (MA)
- … 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 serve. As ... Job DescriptionAccount Director , Clinical Development & Supply With ten facilities in the US , EU, and Asia/Pacific region, and more than 50 depots covering 6… more
- Merck & Co. (Durham, NC)
- …vaccines to the patients around the world with our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support ... operations and associated clean utilities and process equipment.- The Associate Director will manage tactical and strategic process, equipment, and qualification… more
- Tris Pharma (Monmouth Junction, NJ)
- …Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines ... addressing unmet patient needs. We have more than 150 US and International patents (including applications) and have marketed...facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and… more
- Merck & Co. (North Wales, PA)
- …- one that is ready to help create a healthier future for all of us . Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and ... and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the planning and… more
- Merck & Co. (North Wales, PA)
- Job Description Position Description: Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease The Regulatory Affairs Headquarters Associate ... regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety , Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as… more
- Merck & Co. (Rahway, NJ)
- …in leading or supporting compliance investigations and change management.Familiarity with US and EU GMP and Safety compliance regulationsExperience in ... a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the Director ,… 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
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewOverview The Director , Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and ... 2023, we became Great Place to Work-certified in the US for the third year in a row. We...will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …recognize that improving human health starts here and that patients rely on us . We're changing lives for a living. Are you ready to make a difference?The ... incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the design and… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the ... highest quality of raw materials, intermediates and finished products.GENERAL SUMMARY The Director of Operations (Integrated Process Team (IPT) Lead) is an exciting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... development and maintenance of the CCDS, US and EU labeling, and manages the review of...assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company procedures… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development,...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. -The successful candidate will be accountable ... with cross-functional development teams to enable pipeline decisions.- The Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... analysis or blinded data reviews.Production of tables, listings and narratives of safety areas of interest/focus: eg MACE, Potential events related to metabolite,… more
- Merck & Co. (Rahway, NJ)
- …as needed. The position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well as ensuring facility readiness ... pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the...COVID-19 vaccinations for positions, such as in Global Employee Health , where the Company determines in its discretion that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team of representatives across all major regions, incl. direct reports for the US , EU and China, and indirect accountability for JP representatives. As part of ... In the short term, the individual in this role will also act as the US Reg Intel & Policy regional representative, directly responsible for Reg Intel & Policy… more
- Merck & Co. (Rahway, NJ)
- …to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their ... single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, but are not… more
