- Insmed Incorporated (San Diego, CA)
- …of continuous learning, cross-training, and operational excellence.In partnership with Regulatory Operations , and/or third-party service providers, ensure high ... for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations ... working closely with our QA organization to implement ongoing learnings from regulatory inspections.Engage and motivate Clinical Operations employees to execute… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team ... based in Raritan, NJ. Role OverviewThe Director of Operations is an exempt level position working within Technical Operations . This individual will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional,… more
- Merck & Co. (Rahway, NJ)
- …to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is responsible and accountable for ... sterile development portfolio, and delivering on organizational unit priorities.-- The Director will be responsible for new product packaging development for vaccine… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This ... on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject matter expert on the device components… more
- Merck & Co. (Durham, NC)
- …network: build and maintain strong and trusting relationships with site technical operations , quality, regulatory , stability, and other stakeholders to ensure ... a highly motivated individual for the role of Assoc. Director , Engineering.- This role will provide end-to-end support of...team Technical Product Leader as well as site Technical Operations and other key members of the Technical Product… more
- Insmed Incorporated (San Diego, CA)
- …The candidate will collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and external ... Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , EDC Programming will lead and oversee EDC programming, and… more
- Eisai, Inc (Nutley, NJ)
- …years significant clinical pharmaceutical experience (ie, clinical development or operations , regulatory compliance).Substantial experience in Clinical Quality ... area.Anticipate immediate and long-term risks to quality support for overall operations continuity and propose/ implement pre-emptive actions through engagement with… more
- Merck & Co. (North Wales, PA)
- …supervisors, rather than "oversight" is expected at this level. In addition, the Director may be expected to take on one of the following important responsibilities: ... can be cross divisional and relate to optimizing PM capabilities, systems, and operations (e,g., leading efforts to improve planning systems platforms, etc.) or to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) for US Medical Affairs (USMA) understands Our Company's enterprise level strategies and leads cross-functionally with the ... for the US, including tactical execution by the field Regional Medical Scientific Director (RMSD) teams and is accountable for ensuring field teams execute on… more
- Merck & Co. (Rahway, NJ)
- …global businesses units, including those in Manufacturing, Commercial, Technical Operations , Research and Development, and corporate enterprises.As we emerge from ... Have you advised on design standards, project scope, and regulatory compliance as well as act as a liaison...design standards, open space and site planning guidelines, and regulatory compliance such as ADA, environmental, and building codes.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have ... areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision,… more
- Merck & Co. (Rahway, NJ)
- …Director , Assembly and Packaging Platform Technical LeadershipReporting into the Executive Director Packaging Technical Operations the Director Packaging ... sites, packaging & device development and technology teams, supply chain, operations , quality, analytical, regulatory , and project leaders. The successful… more
- Merck & Co. (Millsboro, DE)
- …functional partners.Quality- and compliance-focused with practical experience supporting regulatory inspections, validations and cGMP operations .Required ... problem solving.Provide subject matter expertise for product release, aseptic operations , formulation and fill/finish activities.Ensure compliance with corporate and… more
- Merck & Co. (Rahway, NJ)
- …value proposition validation and channel optionality evaluation are required.The Executive Director , Strategic Solutions and Partnerships will lead a team of ... Business Operations , Innovation, and Key Account Managers committed to developing... to achieve market segment leading growth ratesUnderstanding of regulatory environments in animal health and food productionExperience in… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director ... Substance, Drug Product and Finished Goods globally.- The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of ... packaging components and packaging master data and systems.The Packaging Technical Operations organization aims to be an industry leader in problem-solving,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to be an industry leader in problem-solving,… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Associate Director within Metrics, Analytics & Performance (MAP) has experience in clinical operations and is responsible for leading the ... in support of user needs across Global Clinical Trial Operations (GCTO).Primary responsibilities include but are not limited to:Leading data-strategy-and… more
