- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... agreements including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works (SOWs). The AD will be… more
- Genmab (Plainsboro, NJ)
- … safety related tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned products. Oversee Safety ... and updated regulations/guidelines and assess the impact on drug safety processes at Genmab. Ensure compliance with...on drug safety processes at Genmab. Ensure compliance with regulatory guidelines and internal processes and procedures… more
- Merck & Co. (Durham, NC)
- …(domestic and export), foreign trade zone operation and reporting, trade compliance , and capital planning.Budget Support:The Director , Planning & logistics ... and our internal and external network partners. - The Director , Planning and Logistics will be responsible for leading...Planning teams at Durham Site promoting the behaviors of Safety First, Quality Always as we reliably supply our… more
- Tris Pharma (Monmouth Junction, NJ)
- Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc. ... Junction, NJ headquarters has an immediate need for an experienced Associate Director / Director , Analytical Research & Development. Job Title commensurate with… 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
- Merck & Co. (Millsboro, DE)
- … compliance with governmental regulations, and corporate/site policies including safety and biosafety.Utilize our systems such as Reliance, Atlas SRM, WorkDay, ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as… more
- Merck & Co. (Rahway, NJ)
- …and coordinating lab equipment preventive and corrective maintenance (PM/CM). The US Associate Director is also responsible for leading lab safety and equipment ... who is passionate about lab management and operation support. The Associate Director of Biologics Process Research and Development (BPR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... 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. (Durham, NC)
- …for the daily support of all production equipment to ensure area safety , compliance , production and financial goals are metResponsible for spare ... on all the programs described above. Reports to the site's Executive Director of Engineering, Maintenance and Site Services. GENERAL PROFILE Provides leadership and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Serves as the key DSI contact for PV service ... maintain compliance with global PV regulations for individual case safety reporting, periodic reporting and risk management. Develops and implements strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position As Senior Medical Director for the novel modalities team, you will be part of building, leading and ... Provide leadership in the execution of clinical trials Ensure compliance with SOPs, ICH, GCP and other national and...and KOLs Interface together with VP Medical/Scientific Development with Safety Review Committees and Data Safety Monitoring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the Quality team ... based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt level position with responsibilities for… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …coach cross functional team staff in areas such as quality, compliance , safety , project planning, process development, technology development.Communicate ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities...issues.Prepare tech transfer team goals and objectives based on compliance , scientific design requirements, project timelines and milestones.Build and… more
- Genmab (Plainsboro, NJ)
- …part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head of US ... and in response to requests for information, consistent with promotional compliance and regulatory requirementsDevelops and maintains a network of cooperative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines,… more
- Merck & Co. (Boston, MA)
- …physician-scientist to join our group as a- Principal Scientist (Clinical Director ) in Translational Medicine/Early Clinical Development in the Cardiovascular and ... programs from the preclinical stage through Phase 1 studies of safety , tolerability, pharmacokinetics and pharmacodynamics, to Phase 2 studies demonstrating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety Systems, and fulfillment of data change requests.Responsibilities- Change ... process improvements. Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and evidence. Review of… more
- MEDSTAR HEALTH (Washington, DC)
- …Leads unit-based safety huddles. Escalates care delivery concerns to the Director of Nursing and other leaders as necessary and following the chain-of-command. ... General Summary of PositionThe Assistant Director of Nursing is a member of MedStar...the assigned unit/department. Fosters associates' commitment to improving quality, safety , and cost-conscious patient care outcomes. Collaborates with the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …Potentially manage other RaDS architecture and engineering team members.Ensure ongoing compliance with regulatory safety , Good Practice (GxP) and Validation ... life cycle management Service Level Agreements (SLA)s and adherence to policy compliance procedures with performance metrics in place to track actual relative to… more
