- Merck & Co. (Rahway, NJ)
- Job DescriptionThis position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary ... regulatory updates.Audit vendors/partners of SaMD/IVD/Companion DiagnosticsReports to - Director Regulatory Compliance, Device Quality and RegulatoryLocation… more
- Merck & Co. (Rahway, NJ)
- …evolving expectations and drive impactful change in our industry.Under the direction of the Director and Associate Director , you will be an integral part ... Medicine, Clinical Sciences, Collaborative Development, Continuous Monitoring, Detail-Oriented, Drug Regulatory Affairs , Employee Training Programs, FDA Regulations,… more
- Merck & Co. (Rahway, NJ)
- …leadership of cross functional teams compromised of Global Supply Chain, Global Regulatory Affairs , Labeling, Material Master Data, Finance, Quality, Transfer ... of switch plans with all relevant stakeholders (Donor & Receiving Sites, Global Regulatory Affairs (Labelling), Quality and the Material Master Data Management… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis position reports to the Associate Director , Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain ... (release) activities. Background in quality control, quality assurance, auditing or regulatory affairs .- Effectiveness and creativity in approaching and solving… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis position reports to the Associate Director , Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain ... (release) activities.Background in quality control, quality assurance, auditing or regulatory affairs .-Effectiveness and creativity in approaching and solving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- 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 QA is ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the ... necessary information to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external stakeholders.… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning ... & ManagementEisai Salary Transparency Language:The base salary range for the Associate Director , Medical Education - Oncology is from :162,600-213,400Under… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport ... Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs...and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver ... affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improving the lives of more patients than ever before. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has ... Expert understanding of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well as the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director , Strategic Collaboration role is responsible for fostering partnerships ... of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well...medical, access, public affairs , compliance, legal and regulatory as well as the healthcare ecosystem We commit… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strong collaborators, as we embark on shaping our future. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has ... Rare Bleeding Disorders TA lead (A/B). Works closely with Associate Directors and Sr Brand Managers across the Rare...of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Regulatory Affairs Associate Director , you will be responsible for leading RA team members involved in device project ... degree preferred; medical training preferred. + Minimum 8 years of regulatory affairs experience within the pharmaceutical or medical device industries, ideally… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About ... critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy is responsible for… more
- Merck (Rahway, NJ)
- **Job Description** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The ... updates. + Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality and Regulatory … more
