- Merck & Co. (Rahway, NJ)
- … and assurance services.Position Responsibilities:Under the direction of the Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the Specialist ... in Accounting.Required Experience and Skills:A minimum of 2 years of Audit experience ( internal audit and / or public accounting).Excellent interpersonal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Associate Director , will be accountable for managing relationships with internal stakeholders and external partners relevant to the planning and execution of ... of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you.The Director , Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the ... strategic and execution perspectives for Eisai. Reporting directly to the Executive Director , IT Security, Compliance, & Architecture, s/he is the Global IT… more
- Genmab (Plainsboro, NJ)
- …on drug safety processes at Genmab. Ensure compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and ... inspections. Participate in audit and inspection activities as required. Position is hybrid...inputs at the global level; (c) international experience with internal and external stakeholders; (d) drug safety and/or pharmacovigilance… more
- Genmab (Plainsboro, NJ)
- …to the VP, Head of Global Drug Safety & PV, the Senior Director , Global Drug Safety & Pharmacovigilance Physician serves as the safety expert accountable ... preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(IRBs), and other site personnel as neededStudy-specific subject matter expert (SME) for internal audit or Health Authority (HA) questions related to medical ... Director , Clinical Development Join a Legacy of Innovation...or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1-3 studies (depending… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other site personnel as needed- Study-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(IRBs), and other site personnel as neededStudy-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical ... areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external oversight.Manage and/ or guide the QA review and approval of ... and regulatory authority submissions (IMPD/IND) Responsible to design the audit framework globally for Research area, specifically GLP/GCLP studies.Partners with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and due diligence activities for assigned product(s), as neededActs as audit /inspection Subject Matter Expert (SME) for safety surveillance and risk management ... through the product life cycle.Understanding of Safety Risk Management internal and external environment, including applicable regulations and guidance'sAbility to… more
