- Insmed Incorporated (NJ)
- …teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director , Cybersecurity & Risk ... presenting to Executive Management and Boards of Directors .Strong understanding of risk management, compliance , and audit processes within regulated industries,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The Position The Patient Safety, Compliance & GxP Operational Excellence Lead is responsible for driving efficiency, ... quality, and innovation across US Quality, GxP Compliance Training and Patient Safety Operations. This role ensures that Safety/Quality/Training processes, systems,… more
- Insmed Incorporated (NJ)
- …across all Insmed locations and functions. The position will be responsible for minimizing risk to employees, visitors within operational lab assets or in office ... and asset operations, and workplace safety.This position will advise the Executive Director , Facilities on all aspects of EH&S compliance , performance, and… more
- Insmed Incorporated (NJ)
- …Process leads quality assurance and process improvement initiatives to ensure compliance , consistency, and operational excellence across Insmed's patient ... This role serves as the primary liaison for quality operations, ensuring compliance , consistency, and operational excellence across all patient services… more
- Insmed Incorporated (NJ)
- …strategies to improve processes and set direction in related areas such as compliance , CRO management, risk management, etc.Ability to prioritize and manage ... we're in. Are you?About the Role:Accountable for providing the leadership, strategic, operational planning and oversight of 1-2 indications within one compound to… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning ... plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for Clinical Supply Chain & Logistics… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Associate Director , Compliance Operations will be a key member of Eisai's US Ethics & ... call logs and HCP payment records Serve as the operational lead for Eisai US's Compliance Monitoring...trends, regulatory changes, and program enhancements C ontribute to compliance RAMP ( Risk Assessment and Mitigation Plan)… more
- Merck & Co. (Rahway, NJ)
- …employees. Establishes a viable succession plan for key positions. Ensures cGMP compliance and operational excellence in the laboratories. Maintains a state ... Description: Our Research and Development Division's microbiology team is seeking a Director for the Rahway NJ GMP microbiology operations.- The primary objective of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, external data acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk ... reconciliation, external data acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers responsible for Medical Assessment of ... reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and advisor... is responsible for mentoring coaching and meeting the compliance requirements for the Medical Review Team. Relationship Reports… more
- Merck & Co. (Rahway, NJ)
- …sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance and operational excellence in the laboratories, and for maintaining a ... Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The...raw material & MDCP SME during internal and external compliance auditsEnsuring operational excellence and drive process… more
- Cipla (Central Islip, NY)
- Job Title: Director - Procurement, Cipla North America Reports to: Head SCM, Cipla North America Job Purpose The Director of Procurement is responsible for ... relationships, negotiating favorable contracts, identifying cost-saving opportunities, and maintaining compliance with regulatory and company policies. Success in this… more
- Merck & Co. (Rahway, NJ)
- …Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, Strategic ... is the key interface between clinical development teams and the operational /executional arms within the business.- - The Program Clinical Supplies Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision, ... skills in continuous improvement, project management, change management, and risk management. Responsibilities Leadership, Direction, and Strategy: - In… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …working relationships within Intake and Triage, Medical Review, Submissions and Compliance , Global Safety, and centralized teams (eg, Training and Documentation, ... external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation for case-related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs QA is ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director … more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination ... toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where ... risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with Insmed's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position The position is responsible for supporting daily operational activities related to the Compliance Department's government reporting ... Accountability data in the analytics environment. Relationships Reports to the Director , Government Accountability. Works regularly with other compliance staff… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our ... perimeter defenses, supply chain security, general investigations, security related compliance issues, physical and logical access control and profile management… more
