- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent ... online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets...process of business recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
- Aequor (Newbury Park, CA)
- …instructions/guides, since we work in a framework based on rules/ compliance . Education background preferred for this role: Science/Technology-based degrees are ... Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the… more
- Merck & Co. (Rahway, NJ)
- …processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that ... Job DescriptionThe Associate Director , ESQL is responsible for all activities at...EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …to:Planning, preparing and reviewing pharmacometrics-related drug development plans and regulatory filings. This includes determining scope, design planning and ... analyses. Responsibilities include describing results of these studies in various regulatory documents (IND, NDA, BLA, IB, etc.)Apply model-informed drug development… more
- Insmed Incorporated (Bridgewater, NJ)
- …different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards.Provide scientific ... discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Eisai, Inc (Nutley, NJ)
- …Associate Director , Omnichannel Marketing and Media position reports to the Senior Director , Omnichannel Marketing (HCP and Patient). The associate ... customer journeys and strategies across target audiences as well as ensure regulatory /legal and compliance requirements are met.This role requires strong… more
- Merck & Co. (Millsboro, DE)
- …to our Company guidelinesBrings together the right stakeholders to ensure compliance and sustainability of IT/OT solutionsParticipate in regulatory audits ... Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner ... managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety &… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the ... and functional service providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team. The ideal individual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … task forces, who's goal is to assess impact and oversee the company's compliance with new and changed regulatory obligations related to Corporate Compliance ... accredited institution is required. A minimum of 10+ years combined pharmaceutical, legal, regulatory , and compliance experience required Or a minimum of 8 years… more
- Insmed Incorporated (Bridgewater, NJ)
- …the reinforcement and ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct ... of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance , and Medical Affairs, to align and compliantly… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Engineering Director is directly responsible for leading the Engineering team in the successful design, construction, and commissioning of ... and effectiveness of the operations and participate as a member of the Senior Management Team in developing site strategies and policies and represent the company… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …part of the Compliance organization and will report directly to the Director , Compliance Training, Policy & Communications. This position will be responsible ... for developing unique themes, imagery, etc., under the direction of Director , Compliance Policy, Training and Communications.Project manage various teams… more
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