- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …record keeping and tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling ... Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and...may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory Affairs, ... vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Lead the definition of solutions… 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 position ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory Affairs, ... vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Work with User Support Leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …harmonization and efficiency which leads to cost savings and accelerated worldwide product submissions and approvals. Authors or initiates writing of global standard ... other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etc. Qualifications: Successful candidates will… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- …across both diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! - The Position: We are currently recruiting for a ... Marketing Director , Digital Pathology within our Precision Medicine, Global Oncology...you will be responsible for creating go-to-market strategies & product roadmaps as well as providing guidance & commercial… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and… more
- Merck & Co. (Rahway, NJ)
- …providing expertise in SAP landscape technologies including cloud infrastructure providers, SAP product roadmaps, SAP cloud solutions & integrations, as well as SAP ... in face-to-face meetings, then your employment may pose an undue burden to business operations , in which case you may not be offered employment, or your employment… more
- Merck & Co. (Rahway, NJ)
- …(FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This ... team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including determination of… more
- Merck & Co. (Rahway, NJ)
- …Chemistry Manufacturing & Controls (CMC) development plans.Under the guidance of the Director & Portfolio Lead, the core responsibility of this individual will be ... management efforts to support Chemistry Manufacturing & Controls (CMC) product development from First in Human to Transfer to...in harmony with the portfolio. In addition, the Associate Director will be expected to participate in development of… more
- Merck & Co. (Rahway, NJ)
- …Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their ... and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within… more
- Merck & Co. (Rahway, NJ)
- …Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to optimize label and obtain shortest time to ... world.Looking for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for development and implementation… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... talent development, and partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell Based Sciences and will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe role of Director , Global Communications, Oncology is a unique opportunity to join our company, a recognized leader in oncology, as a key member of ... this role will work under the guidance of the Executive Director , Global Oncology Communications, in a fast-paced and ever-changing environment.-Responsibilities… 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 ... . - Responsibilities include but are not limited to: Working independently through product development teams to devise a patenting strategy with the goal of building… more
- Merck & Co. (Rahway, NJ)
- …mitigating technology risks that could compromise sensitive data or disrupt business operations . -The primary objective is to develop and execute a comprehensive ... across our company's business divisions, leveraging team expertise and resources.Advise product and project teams about risk minimization strategies and secure… more
