- Merck & Co. (Upper Gwynedd, PA)
- …acceptability and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document ... per established business processes and systems.-Identify, communicate and escalate potential regulatory issues to GRACS CMC management , as neededDemonstrate an… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... development of regulatory strategies to ensure effective achievement of regulatory /business objectives. The Executive Director will direct the development… more
- Merck & Co. (Rahway, NJ)
- …and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… more
- Merck & Co. (Rahway, NJ)
- … compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project Management :Provide leadership in the development, commercialization, and transfer ... product technology transfer programs in both development and lifecycle management , ensuring compliance with relevant regulatory standards.Ensure robust… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …investigate, and resolve trends. Report results to Divisional and Regional Quality/ Management councilsProvide guidance and consultation services for regulatory ... Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to...Inspection, Quality Control Inspection, Quality Management , Quality Management Systems (QMS), Quality Metrics, Regulatory Compliance,… more
- Merck & Co. (North Wales, PA)
- …will build and coach your team in the development of project management , communication, and collaboration skills in support of our clinical trials.Job ... elements (eg operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and governance).… more
- Merck & Co. (Rahway, NJ)
- … Management , Process Optimization, Project Management , Project Portfolio Management (PPM), Publications Management , Regulatory Compliance, Risk ... GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate...Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary Under the guidance of an Executive Director , has primary responsibility for developing value evidence strategies, and planning/managing ... value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes research leadership… more
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Insmed Incorporated (San Diego, CA)
- …on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of the ... technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating method characteristics… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... Core Data Sheet, USPI, EU SmPC and related patient information ) for the Genmab portfolio of products. The lead...The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be… more
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Boston, MA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a highly skilled and experienced Director of Companion Animal Vaccine to lead our efforts in developing and managing our companion ... research and development of new vaccines, ensuring they meet regulatory requirements and industry standards.Collaborate with cross-functional teams, including R&D,… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …Hill, Kansas seeks a highly qualified, dynamic professional to provide leadership, management and direction on all the various components of planning, economic and ... policies, procedures as well as capital and special project management that align with the City's priorities? If so,...Duties: Under the supervision of the City Administrator, the Director of Community Development is an exempt position under… more
- Eisai, Inc (Nutley, NJ)
- …stakeholder management , vendor management , budget planning & resource management .Demonstrated track record as Study Director (or equivalent role) with ... profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at...opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
