- Merck & Co. (Rahway, NJ)
- …device and combination products, guiding cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team ... Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You… more
- Genmab (Plainsboro, NJ)
- …and be responsible for the development, implementation and maintenance of US/global regulatory strategies (in line with Target Product Profile). For approved ... documentation to support successful IND/CTAs as well as BLAs/MAAs. Evaluate various regulatory mechanisms that allow optimization of product development (eg,… more
- Merck & Co. (Rahway, NJ)
- …participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks Creatively advise ... ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion...mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization and join the leadership team of Small Molecule ... organization is responsible for three core areas within SM S&T: (1) technical product leadership across the lifecycle of product franchises, (2) project and… more
- 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)
- …continued R&D and drive access to life-saving medicines for patients? If so, the Director , Biologics Patent Attorney role , at our Company could be an ideal ... areas of the business including discovery, development, manufacturing, and supply, regulatory , business development, commercial groups, and other legal functions . -… 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
- Merck & Co. (Rahway, NJ)
- …program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie ... human health), and balancing needs of patients & ensuring stable supply of product . -Primary activities include, but are not limited to:--Interacts closely with key… 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
- 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
- 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
- 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
- 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
- Genmab (Plainsboro, NJ)
- …to enhance efficiency and productivity across the organization.Collaborate with legal and compliance teams to ensure adherence to all regulatory requirements and ... and growing organization? At Genmab, we're seeking a Senior Director , Strategic Planning & Effectiveness to drive cross-functional communication, alignment… 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
- 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
