- 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
- 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
- Merck & Co. (Rahway, NJ)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory … 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director , has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… 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
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … 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
- Columbia University (New York, NY)
- …Summary Reporting to the Senior Associate Dean of Administration and Faculty Affairs , the Assistant Director assists with the adjunct faculty, associate , ... Carries out special projects and financial analyses as directed by the Senior Associate Dean of Administration and Faculty Affairs . (20%) Has secondary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …RWE Epidemiology Legal and compliance Marketing/ commercial GMP QA/ Supply chain / Regulatory Affairs Leadership/ team management: Create a high performing team ... research areas centered around rare diseases and immune disorders. JOB SUMMARY The Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is… 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
- 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)
- … issues to GRACS CMC management, as needed + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company ... **Job Description** GRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory … more
- Bayer (Whippany, NJ)
- …brilliant and diverse minds to make a real difference, there's only one choice.** ** Associate Director Medical Affairs Insights & Analytics** The ... Associate Director Medical Affairs Insights & Analytics role involves managing timelines, resources, and cross-functional teams to ensure successful project… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …**Key Responsibilities:** + Strategic Medical Leadership: Drive medical affairs activities throughout new product development-from concept ideation through ... commercial launch-ensuring all products meet rigorous safety, efficacy, and regulatory standards. + Clinical Risk Assessment: Collaborate with the Global Medical… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …partner closely with the LSM worldwide business team, regional leadership in the Medical Affairs Function and the Associate Director of Medical Affairs ... directly to the business unit Vice President of Medical Affairs , the Director of Medical Affairs... regulatory requirements, and support appropriate use. The Director of Medical Affairs needs to have… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** The Associate Principal Scientist ( Associate Director ) is responsible for developing and implementing Regulatory Chemistry, ... questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Grifols Shared Services North America, Inc (Newark, NJ)
- …2 years of experience. **Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in the United States (non-California), is ... insights to internal stakeholders 12. Partner with patient advocacy, regulatory , HEOR, and market access to support US and...**For California:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. **EXAMPLE RESPONSIBILITIES:** + As needed, represents ... regulatory strategies, processes, standards, practices, efficiencies and capabilities. + Represents Regulatory Affairs and may serve as Regional Lead or… more
