- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL,… more
- Merck & Co. (North Wales, PA)
- …processes, and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- Product managers ... authority regulated environment - Understanding of pharmacovigilance, medical affairs, clinical operations and product quality complaints processes and systems… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience ... pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OED; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs: Utilizes ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management: Build strong internal… more
- Genmab (Plainsboro, NJ)
- …providers.The focus of this role will include stakeholders in the business domains Field Operations , Medical & Regulatory Affairs and US and Japan Market and ... and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, such as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Tris Pharma (Monmouth Junction, NJ)
- …between marketing and other cross-functional teams (ie, Medical Affairs, Sales, Regulatory Affairs, Operations , etc.)Collaborates closely with Analytics team to ... from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior Director , Head… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... record keeping and tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling… more
- Insmed Incorporated (San Diego, CA)
- …clinical development team, partnering closely with heads of clinical operations , toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, ... for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead… more
- Merck & Co. (Rockville, MD)
- Job DescriptionThe Science and Regulatory Policy (SRP) team advocates for policy priorities that support the pipeline and portfolio for our Research & Development ... business goals.The SRP team comprises of four contributing teams:Global Regulatory Policy (GRP)Data & Advanced Digital Technology Policy (DADTP)Evidence Policy,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drives the long-term strategic direction of Novo Nordisk Inc. (NNI)/North America Operations (NAO) and leads all US commercial efforts for Novo Nordisk's Rare ... as we embark on shaping our future. The Position The Associate Director , HCP Experience has overall strategic and operational responsibility as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance ... and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders. Participates in… more
- Genmab (Plainsboro, NJ)
- …informatics, Research data products, Lab systems automation, Development Operations , Pharmacovigilance, Regulatory , integration and Data visualization.At ... and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part of our IT &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... record keeping and tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process qualification, packaging and labeling. This position will interface with Operations , Regulatory , Quality Assurance, Finance, R&D, Project Management and ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities...for new products and processes to be included in regulatory submissions.Coordinate and communicate with cross function team members… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sites. These business functions include but are not limited to Clinical Operations , 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,… more
- Merck & Co. (Durham, NC)
- …at the Durham site.-- The successful candidate will report to the Associate Director , Laboratory Operations to lead start-up new laboratories for microbiological ... pushing and pulling.Ability to travel. WORKING RELATIONSHIPS: Reports to Associate Director , Laboratory Operations .Represents the laboratory in cross functional… more
- Abbott (Alameda, CA)
- …female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction and On-Market Changes** ... with regulatory metrics/information. **WHAT YOU'LL DO** + Develop global regulatory strategies for product development and planning throughout the … more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs:** **_*This ... located in Foster City, CA_** The Associate Director , Analytical Regulatory Science, collaborates with product development, manufacturing and quality teams… more
- NJEDA (Trenton, NJ)
- …development at NJEDA. Job Overview + The Director of Legislative and Regulatory Affairs works to support the entire product development lifecycle from bill ... a staff of attorneys and paralegals that support NJEDA's regulatory , product development, and ethics compliance activities....The Director will report to the Managing Director of Legislative and Regulatory Affairs and… more
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