- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director Safety & Environment The Rahway Environmental, Health, and Safety (EHS) Director is responsible for ... areas for global teams as part of the Corporate Headquarters.- The Rahway EHS Director is a member of the Rahway Site Coordination team and collaborates with key… more
- Merck & Co. (Rahway, NJ)
- …that all team activities are completed with the highest regard for safety , quality and regulatory compliance .Qualifications: Education: Degree in engineering or ... Job DescriptionDescription:The Director of Chemical Engineering R&D is responsible for...filing towards world class supply targets. In addition, the Director participates in network wide activities within Small Molecule… more
- Merck & Co. (Durham, NC)
- …vaccines to the patients around the world with our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support ... while ensuring product quality and optimized maintenance processes, regulatory compliance , employee and environmental safety , integration of new/existing… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… more
- Merck & Co. (North Wales, PA)
- …assetsImplementing Safety Label Updates on promotional assets and ensuring compliance with Subpart E regulations, when applicablePartnering with the US marketing ... Job DescriptionThe Associate Director US Oncology Marketing Digital Engagement will direct...our Ways of Working valuesConducting all activities in full compliance with our policies, values, and standards Position Qualifications… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management sciences, and risk management tools and resources.- Risk Management Compliance Inspection Readiness Champion. Serve as member of Risk Management office ... to ensure risk management activities allow for effective preparation for inspections/audits. Serve a key support during Risk Management Inspections.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops ... a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to… 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 ... ready to maximize your potential with us? The Position The Associate Director of Enterprise Functions Insights & Analytics will provide holistic, insight-driven… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPrimary responsibilities include: Safety platform release managementManage the business area accountabilities for the scoping & implementation and ... of future release roadmapStay current with industry trends and ensure compliance with relevant regulations and guidelinesGeneral Business Delivery SupportKeep track… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in...for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance team to ensure that GVP audits are planned,… 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 ... the Supply Chain business. Relationships Reports to the Senior Director , Supply Chain and is in direct contact with...Manage the DSA creation and amendments and ensure ongoing compliance to the requirements and conditions Lead the reporting… 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 ... maximize your potential with us? The Position The Senior Director , Enterprise Functions Insights Lead is responsible for leading...(eg Finance & Supply Chain, People & Organization, Legal, Compliance , etc.). This person is the focal point for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the design and ... of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility...Provide leadership in the execution of clinical trials Ensure compliance with SOPs, ICH, GCP and other national and… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… 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 ... even under adversity Operational mindset and continuous improvement: Considers compliance , regulatory, quality assurance and other requirements when supporting all… more
- Insmed Incorporated (San Diego, CA)
- …materials.Leads Clinical Sub-team meetings.Approves action plans to address protocol compliance , safety , data and administrative issues with investigational ... operations including study planning, financial oversight, project deadlines and ensuring compliance with Good Clinical Practices as well as federal and local… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE). - Direct Project Support: ... responses submitted to health authorities globally with respect to data standards, compliance , etc. May represents the function at health authority meetings. Reviews… more
