- Merck & Co. (Rahway, NJ)
- …, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's ... an effective implementation and oversight model to maintain best-in-industry regulatory compliance.The Vice President Regulatory Affairs ,… more
- Merck & Co. (Rahway, NJ)
- … Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... Job DescriptionOur Regulatory Affairs team bring new medical...Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide product regulatory strategy to optimize label and… more
- Eisai, Inc (Nutley, NJ)
- …key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs , Medical Affairs and ... want to hear from you.The Medical Director, US Medical Affairs provides medical leadership for medical affairs ...area to provide strategic input for the development of product strategies and liaises with external stakeholders to solicit… more
- Aequor (Thousand Oaks, CA)
- …applications Serve as functional area lead on product teams (eg, Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) ... supplemental drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs , Research,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned ... and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to...Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and… more
- Eisai, Inc (Nutley, NJ)
- …key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs , Medical Affairs and ... Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive tactics for assigned therapeutic area. Under… more
- Tris Pharma (Monmouth Junction, NJ)
- …is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) ... The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs , Manufacturing, Quality, etc. to identify, evaluate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure ... limited to: Global Project Team, Safety Management Team, Clinical Safety and Pharmacovigilance Medical Affairs , Companion Diagnostics/ Device Laboratories… more
- Tris Pharma (Monmouth Junction, NJ)
- …oversight of clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs , Product Development, Research and Development ... (R&D), Quality Assurance (QA), Pharmacovigilance, Medical Affairs , etc.) on strategic and tactical clinical development issues...trial data and translates data into actionable plans at product levelContributes to Medical aspects of Regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services Project Management and Operational… more
- SSS Company (Atlanta, GA)
- …ointments, creams, tablets. Job Description Our company is seeking an on-site Quality Assurance/ Regulatory Affairs Manager to join our company to oversee ... founded in 1826 with the introduction of our first product , SSS Tonic. Our product line includes...organized, and able to work independently. Primary Responsibilities - Regulatory Affairs Ensures compliance with FDA, EPA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex-US ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etcQualifications: Successful candidates will be able ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this workPossesses in-depth… 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 ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... and Reimbursement, Finance, IT, etc. Other internal relationships include Public Affairs and CMR. External relationships include relations with external consultants,… more
- ICP Group (Andover, MA)
- …and the Asia Pacific region. ICP Group is looking to identify a Product Safety & Regulatory Affairs Specialist. The PSRA Specialist ensures that all ... credential portfolios. + Review all printed materials, including product labels, for compliance with regulatory requirements,... product compliance, regulatory compliance and/or product stewardship experience. + BS in Safety ,… more
- Indorama Ventures (Houston, TX)
- … toxicologist as a Product Safety Toxicologist for our global Regulatory Affairs organization. The position will be based at our division's headquarters ... working a hybrid office/remote schedule. The Product Safety Toxicologist will report directly to the Regulatory... Safety Toxicologist will report directly to the Regulatory Affairs Director. **What will be expected… more
- AbbVie (North Chicago, IL)
- …Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety , Regulatory Affairs (RA) and Medical Affairs (MA) QA team ... across all stages of discovery and development for the product 's lifecycle to achieve product realization and...stakeholders including but not limited to Pharmacovigilance and Patient Safety , Regulatory Affairs and Medical… more
