- Merck & Co. (Rahway, NJ)
- …chemical and biochemical processes, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends ... R&D and DSCS. --The candidate will have experience in an innovative analytical/ regulatory /GMP environment.The Director will effectively team with the SMAR&D… more
- Merck & Co. (Rahway, NJ)
- …software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product development to ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… more
- Merck & Co. (Rahway, NJ)
- …and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and ... Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Merck & Co. (Rahway, NJ)
- …and execute media relations strategies and outreach campaigns for strategic product prioritiesDemonstrate deep understanding of media and regulatory landscape ... Job Description Overview: The Director , Global Media Relations, is responsible for developing and executing a global media strategy that showcases our Company's… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Global Pharmaceutical Communications The role of Director , Global Pharmaceutical Communications - New Products is a unique opportunity to ... this role will work under the guidance of the Executive Director , Global Pharmaceutical Communications, in a fast-paced and ever-changing environment.-This position… more
- Merck & Co. (Rahway, NJ)
- …organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early Drug Development and/or ... & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Merck & Co. (Rahway, NJ)
- …years of leadership experience with deep working knowledge of device, biologic/drug product , and process development including regulatory submission and approval ... Job DescriptionOur company's Device Product & Process Development (DPPD) Team designs, develops,...products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead… more
- Merck & Co. (Rahway, NJ)
- …and applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global ... the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics,… more
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... financial milestones and related payment schedules) Advanced knowledge of Regulatory and Compliance requirements related to Pharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Programs, Patient Safety, Quality, NNI IT and Telephony, Medical Information, Compliance , Regulatory , Legal and Privacy. External relationships include Patient ... Are you ready to maximize your potential with us? The Position The Associate Director will be the lead who is responsible for ensuring that all aspects of… 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) ... tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Tris Pharma (Monmouth Junction, NJ)
- … compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to medical inquires, disseminate scientific information ... opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is...and report Adverse Events (AEs) and Product Quality Complaints (PQCs)Collaborates with VP/Medical Affairs to ascertain… more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, ... 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)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… 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) ... tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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, Informatics Services, Project Management and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve ... execution, maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs… more
- Genmab (Plainsboro, NJ)
- …agile and product -oriented development teamsSolid experience with Compliance ( regulatory and industry-specific) and Security frameworksDemonstrated ... and authentic is essential to fulfilling our purpose.Job Description - Director , Digital Assets, Information SecurityPosition Summary: The Director Information… more
