- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange ... process improvements.Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and evidenceReview of Change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... Start-Up activities for PV Safety Operations. This position oversees the creation of SAE...where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development. Are you ready to maximize your potential with us? The Position The Associate Director , Data & Analytics Governance is responsible for the governance ... skills to ensure vision is maintained across various NNI functions. Relationships The Associate Director , Data & Analytics Governance reports to the Senior … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... (USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director … more
- Genmab (NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development ... as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Merck & Co. (Lower Gwynedd, PA)
- …Us: The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late ... cell-based assays (eg, neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the… more
- Merck & Co. (North Wales, PA)
- …Manager - PV Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance, this position will be responsible for managing the ... pharmacovigilance strategies that meet regulatory requirements and ensure patient safety , quality and compliance.-Oversee PV processes: Responsible for overseeing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets ... (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical ... Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT functions at… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Clinical Director (Distinguished Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... With a focus on late-stage development, the Executive Clinical Director will manage the entire cycle of clinical development,...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development,...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and hormone therapy products. Relationships The position reports to a Senior Manager, an Associate Director , or a Director in Strategic Pricing and ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Are you ready to maximize your potential with us? The Position The Associate Manager of Technical Production will be responsible for overseeing the technical aspects… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... requests to ensure seamless event execution. Relationship This job reports to the Director of the Conference Services and Production Operations and is part of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in a fast-paced environment. Relationships This position will report to an Associate Director of Strategic Market Intelligence. Extensive interaction with the ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new ... applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Merck & Co. (Durham, NC)
- …capability at the Durham site.-- The successful candidate will report to the Associate Director , Laboratory Operations to lead start-up new laboratories for ... grasping pushing and pulling.Ability to travel. WORKING RELATIONSHIPS: Reports to Associate Director , Laboratory Operations.Represents the laboratory in cross… more
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