- Merck & Co. (Upper Gwynedd, PA)
- … 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
- Bausch Health (Bridgewater, NJ)
- Associate Director , Regulatory Affairs Job Location: Hartford, Connecticut, USA | NewHaven, Connecticut, USA | Stamford, Connecticut, USA | Atlanta, ... it-where your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development… 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
- Sanofi (Morristown, NJ)
- Job Title: Associate Director , Global Regulatory Affairs - Global Labeling Strategy Location : Morristown, NJ or Cambridge, MA (Hybrid) About the Job Are ... critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy is responsible for… more
- Kyowa Kirin North America (Princeton, NJ)
- …NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs , Advertising and Promotion ... ensure compliance with US regulatory requirements. In addition, the associate director will be responsible for supporting preparation of FDA Form 2253… 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)
- …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
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take ... also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and… 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
- 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)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and ... in alignment with overall business objectives. Relationships Reports to the Sr. Director , Wegovy Consumer Marketing . C ollaborates with sales, marketing, training,… more
- Genmab (NJ)
- …to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and ... and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to...Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… 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
- 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
- Monster (Bernards, 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
- Inside Higher Ed (Greenville, NC)
- Director of Revenue Cycle Position Number: 500334 Full...units include the Offices of the Dean, Vice Dean, Associate Dean for Student Affairs , Associate ... Dean for Research, Associate Dean for Clinical Affairs , Associate Dean for Extramural Clinical Practices,...the Faculty Practice in Ross Hall. Job Duties: The Director of Revenue Cycle reports to the Assistant Dean… more
- Merck & Co. (Rahway, NJ)
- …a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Eli Lilly and Company (Indianapolis, IN)
- …better for people around the world. Eli Lilly and Company seeks an Associate Director - Global Environmental Sustainability (P4) to provide functional ownership ... internally and externally to ensure that current and emerging global regulatory requirements, stakeholder expectations, and best practices are integrated into… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us. Position Summary The Associate Director of WW Medical Neuroscience, Neurodegeneration Medical ... including WW Commercial, Research and Development, Global Drug Development, HEOR, Regulatory Affairs , and other global medical stakeholders. This position… more
