- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… more
- Merck & Co. (Durham, NC)
- …areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety , Process Development, Technical Services, Utilities and Validation.- Position ... site and each manufacturing areaProactively maintaining a strong state of compliance with all validation requirementsDefining and maintaining metrics to streamline… more
- Insmed Incorporated (San Diego, CA)
- …materials.Leads Clinical Sub-team meetings.Approves action plans to address protocol compliance , safety , data and administrative issues with investigational ... operations including study planning, financial oversight, project deadlines and ensuring compliance with Good Clinical Practices as well as federal and local… more
- Merck & Co. (Durham, NC)
- …vaccines to the patients around the world with our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support ... while ensuring product quality and optimized maintenance processes, regulatory compliance , employee and environmental safety , integration of new/existing… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewOverview The Director , Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and ... you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support ... incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the design and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Insmed Incorporated (Bridgewater, NJ)
- …associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program ... analysis or blinded data reviews.Production of tables, listings and narratives of safety areas of interest/focus: eg MACE, Potential events related to metabolite,… more
- Merck & Co. (Rahway, NJ)
- …the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the ... to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and Quality… more
- Catalent (Harman, WV)
- The Manager, Supply Chain - Warehouse , reporting to the Director , Supply Chain, has an opportunity to make a significant impact on the way that the Harman's site ... efficiently and partner with other functional leads to improve operational performance and compliance will be a success factor for this role.This individual will use… more
- Merck & Co. (Durham, NC)
- …control, Delta V Network and troubleshooting in compliance with system life cycle (SLC), GMP, Data integrity, safety , and environmental regulations. Provides ... Periodically reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety .Assisting in the development and… more
- Catalent (St. Petersburg, FL)
- …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent ... to assure qualified status of existing and prospective suppliers in compliance with Global procedures and Regulatory requirements Generate Global Quality Agreements… more
- Merck & Co. (Rahway, NJ)
- …ensures that all activities are completed with the highest regard for safety , quality and regulatory compliance . Qualifications: Education Minimum Requirement: ... Job DescriptionDescription:The Senior Principal Scientist reports to the Senior Director Chemical Biotechnologies of Process Research & Development Enabling… more
- Novo Nordisk Inc. (Durham, NC)
- …diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life -changing careers, and the opportunity to help improve the quality of life ... leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require ... writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... transactions. At Novo Nordisk, you will have the opportunity to build a life -changing career in a global business environment. We encourage our employees to make… more
- Dana-Farber Cancer Institute (Boston, MA)
- The Director of Nursing is responsible for the planning, implementation and evaluation of clinical operations and personnel management of the assigned patient care ... experience while maximizing provider time and space utilization. The Nurse Director uses extensive theoretical, evidence-based, and experiential knowledge to advance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director of Data Stewardship, Cataloging and Process, develop implement a data ... business stakeholders from multiple functions, domain experts in privacy, security, and compliance and technology and IT owners from the digital transformation unit,… more
- UTMB Health (Galveston, TX)
- Program Director , Life Safety & Environment of Care Compliance (Hybrid) **Galveston, Texas, United States** Executive - Facilities UTMB Health ... Care (EOC) Joint Commission Compliance + Extensive knowledge of Life Safety compliance related to Joint Commission requirements + Demonstrated… more
