- 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
- Merck & Co. (Rahway, NJ)
- …Global Marketing Director to focus on expanding and growing our product , the first-and-only HIF2 inhibitor, as an impactful approach to cancer treatment.- ... teams, Key Opinion Leader engagement execution, competitive strategy, target product profile development, health authority interactions, global regulatory … 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)
- …Summary Under the guidance of a senior leader, a Principal Scientist/ Director , has primary responsibility for developing value evidence strategies, and ... in their HTA submissions. The incumbent is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure that … more
- Merck & Co. (Rahway, NJ)
- …degree is preferred.Leadership experience with working knowledge of device, biologic/drug product , and process development including regulatory submission and ... 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)
- …performance reviews as the quality lead for the oversight platform, Supporting product development teams in outsourcing activities to enable our diverse pipeline ... and serving as Quality spokesperson, on a variety of Quality or compliance -related issues. - Required Experience : Minimum of 5 years within pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small molecules ... incumbent will play a pivotal role in meeting cross-divisional and regulatory requirements by their strong scientific background, excellent communications skills,… more
- Merck & Co. (Rahway, NJ)
- …service activities to ensure supply continuity that meets our quality, compliance , and regulatory standards.Strategic collaboration with Procurement and finance ... needs. The role is also accountable of all sourcing strategies of any product , comparator or components needed in the clinical supply chain. The role oversees… 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)
- …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
- Merck & Co. (Rahway, NJ)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be ... and manufacturing to manage clinical development projectsAssist the Senior Director , Associate Vice-President/Vice-President and Product Development Team Lead… 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)
- …commercial assembly equipment and processes for drug delivery systems. Reporting to the Director responsible for this area, you will partake in device assembly and ... and provide hands-on troubleshooting to operations as needed.Key Responsibilities:Understand product design, functionality, storage, and handling requirements to develop… 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
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... stability assays for testing of clinical trial material and in support of product and process development.A strong team player with excellent oral and written… 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)
- …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
- 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
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a ... documentation to support successful IND and (s)BLA submissions. Evaluate various regulatory mechanisms that allow optimization of product development (eg,… 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
