- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... budgeting guidance. Collaborating with cross-functional teams to ensure contractual compliance and driving continuous improvement. Works closely with suppliers to… more
- Genmab (Plainsboro, NJ)
- …development.Oversee resource allocation and ensure effective team planning.Regulatory and Audit ComplianceEnsure compliance with country-specific clinical supply ... is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global Clinical Drug Supply… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …groups to ensure comprehensive auditing of Business Partners as required to assure compliance with PV agreements. Participate in audit and inspection readiness ... associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV) service… more
- Hackensack Meridian Health (Belle Mead, NJ)
- …to transform healthcare and serve as a leader of positive change. The ** Director , Compliance and Risk Audit ** assists the Compliance Officer in the ... **Responsibilities** A day in the life of a ** Director , Compliance and Risk Audit ** at **Hackensack Meridian** **_Health_** includes: + Corporate … more
- Highmark Health (Trenton, NJ)
- …for the technology component of the comprehensive, risk -based information systems audit , advisory, and compliance plan for the Highmark Health enterprise ... with senior operational and technology business leaders, ensures that the respective risk management and compliance programs address applicable laws, rules,… more
- Bristol Myers Squibb (Princeton, NJ)
- …and external vendors to promote a culture of quality, risk management and compliance excellence. The Senior Director will also play a crucial role in ... with RGO and cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement… more
- Humana (Trenton, NJ)
- …and external business partners in delivering results in a manner that minimizes compliance risk exposure for the Company. Responsible for completing risk ... community and help us put health first** The Associate Director , Compliance ensures compliance with...risk assessments and create annual work plans to audit and monitor operational performance; + Interpret and define… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …company to inspire you and empower you to shine? Join us as an Associate Director , GCP Compliance based remotely reporting to the Director , GCP ... development of applicable processes and tools + Establish and lead proactive risk -based compliance assessments for clinical trial delivery functions and ensure… more
- Bristol Myers Squibb (Princeton, NJ)
- …be recognized internally and externally as an expert in mitigating healthcare compliance risk through providing advice, drafting policy, providing education and ... Reporting to the Head of US and Above Market Compliance and Ethics Organization, this role partners with senior...Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory, IT, Audit , Finance and HR to build and integrate one… more
- Bristol Myers Squibb (Princeton, NJ)
- …vendor quality oversight: + Provide direction and oversight to the vendor qualification and audit program to ensure regulatory compliance + Develop the audit ... laboratory vendor audits, including audit scope to assess the vendors risk , quality systems, capabilities and performance + Supports the development of clinical… more
- Bristol Myers Squibb (Princeton, NJ)
- …Quality is responsible for effective management of the GLP/GCLP/GCP specialty laboratory audit program, with an emphasis on risk -based management, regulatory ... and identify solutions. + Assist in managing the LQA audit program, including development of audit strategy...compliance : + Compile documentation in preparation for the audit . + Maintain NCQ audit database, perform… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- Description: The Director , ESG Accounting and Internal Controls will lead the development, implementation, and oversight of our Environmental, Social, and Governance ... data, manage the ESG internal control environment, and drive regulatory compliance across ESG disclosures. This position will partner closely with cross-functional… more
- Merck (Trenton, NJ)
- …goals, through a risk -based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations. + Proven Lean Six ... **Bring energy, knowledge, innovation to carry out the following:** + Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change… more
- United Therapeutics (Trenton, NJ)
- …other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case ... commercial product portfolio. This position strategizes and implements plans to ensure compliance with global regulations and guidelines with regards to safety data… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a key role in the PDT ... provided to patients and Health Care Providers while the risk of write- offs is minimized. **Labeling Documents Authoring,...EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the development ... CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers… more
- Hovione (East Windsor, NJ)
- …is why we are In it for life. You will be responsible to: Independent compliance function within HSE focused on the development and implementation of an internal ... audit methodology to monitor and report on management system...applications. - To develop and implement a Chemical Hazard Risk Control program. - To drive the development and… more
- Sanofi Group (Bridgewater, NJ)
- …savings objectives. + Ensure procurement technical excellence (TCO, SRM, Market Intel, Risk Management, Innovation, CSR, HSE, compliance , quality ) at his/her ... and/or participates in strategic negotiations according to needs **Procurement Risk Management, Compliance , Ethics and CSR** +...part in regular training sessions to audits requirements + Compliance sanity checks + Pre & Post Audit… more
- Intermountain Health (Trenton, NJ)
- …procedures, guidelines, contracts and standards for assigned service line(s). Collaborates with Audit to ensure compliance . Manages requests for product standard ... business to establish and manage strategic supplier goals. Monitor supply risk contracted suppliers in portfolio. Drives continuous improvement plans with suppliers.… more
- Hackensack Meridian Health (Edison, NJ)
- …at Hackensack,) + Assists the Director in the development of the annual risk assessment / audit work plan. + Adheres to the standards identified in ... audit plans under the general direction of the Director - Audit Services. This is a...may involve allegations of wrong-doings such as theft, fraud, non- compliance , etc. + Keeps the Director and… more
