- Insmed Incorporated (NJ)
- …for assigned products. Lead the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory ... and risk communication for assigned development products; perform medical assessment of individual adverse event reports generation; and review aggregate reports… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment , risk ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence… more
- Insmed Incorporated (NJ)
- …, and environmental protection for all Insmed locations.Key duties include risk assessment , developing safety policies, managing training programs, and ... ensuring compliance with regulations like OSHA, EPA, and other federal,...of Environmental Health & Safety (EH&S), the individual will lead the development, implementation, and management of a company-wide… more
- Merck & Co. (Rahway, NJ)
- …related activities to go live with new equipment and infrastructure (eg Quality risk assessment , safety assessment , data integrity, change management, ... (CSO), Logistics and Regions, and External Partnerships & Supply (EPS).- The technical lead owns business continuity of GCS facilities and equipment as well as… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment , risk ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment , risk ... and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …continuous improvement in collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence assessments of GMP ... necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Kaiser, institutions, GPOs) and other area/regional accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to Contract (includes ... pre-deal assessment /analysis, development of business cases for Pricing Committee, offer...as well as with internal stakeholders (Government Contracts & Compliance , Rebate Operations and Insights, Market Access Strategy, Legal,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as Quality, Safety, Compliance , IT based on business understanding and risk assessment ; collaborate with requesting business stakeholders as needed Triage ... in-scope service contracts with third-party vendors, across low, medium, high business risk and complexity, from intake to execution, in collaboration with SME… more
- Eisai, Inc (Nutley, NJ)
- …performance and reduce potential risks.Oversees vendor qualification and collaborate with Vendor Risk Assessment teams to ensure vendor strategies comply with ... The Senior Director oversees vendor qualification, governance frameworks, and compliance with ICH/GCP guidelines and local regulations, ensuring inspection readiness… more
