- 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 ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … 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
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary Under the guidance of an Executive Director , has primary responsibility for developing value evidence strategies, and planning/managing ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may… more
- Merck & Co. (Rahway, NJ)
- …industry standards.Collaborate with cross-functional teams, including R&D, marketing, sales, and regulatory affairs , to ensure the successful launch and ... Job DescriptionWe are seeking a highly skilled and experienced Director of Companion Animal Vaccine to lead our efforts in developing and managing our companion… more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, … more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs - Neurology is from :272,200-357,300Under current… 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
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the ... International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education is from… 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)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle ... differentiation.Collaborate with our Global Marketing, Clinical Development, and Government Affairs on the go-to-market strategy for the preclinical indication and… 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
- BioSpace (New York, NY)
- …within the organization. Cross-functional Collaboration: Work closely with clinical development, regulatory affairs , market access, and commercial teams to align ... Senior Director , and Lead Principal Scientist. Define a Medical Affairs organization in conjunction with our current Medical Scientific Liaison (MSL) team… more
- Katalyst HealthCares and Life Sciences (Newark, NJ)
- Responsibilities: The Regulatory Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for ... of the QRC team and report to the Sr. Director QRC responsible for microbiology quality, regulatory ,...role and want to work to build a world-class Regulatory Affairs organization-read on. Responsible for a… 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
- Aquestive Therapeutics (Warren, NJ)
- Job Title: Director , Advertising, Promotional & Labeling Reports To: Sr. VP, Regulatory Affairs Job Summary: We are seeking a highly experienced and ... Director of Advertising, Promotional & Labeling to lead regulatory review of promotional and labeling materials for both...JD, or MBA) preferred. *10+ years of experience in Regulatory Affairs , including a minimum of 5… more
