- Legend Biotech USA, Inc. (Raritan, NJ)
- …to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance . Address recurring deviations and ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- Merck & Co. (Rahway, NJ)
- …to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … compliance reporting and quality tasks in order to ensure consistency and compliance in all activities performed by Patient Safety . Relationships Reports to ... and support the evaluation of daily GXP lists for regulatory submission of individual case safety reports...compliance issues Collaborate with other units within Patient Safety , other business areas at NNI and Global … more
- Merck & Co. (South San Francisco, CA)
- …lab sites. - Integrates EHS programs into daily operations to assure regulatory compliance , achieves continuous performance improvement, meeting EHS performance ... business goals and valuesSupports the site's recordkeeping and completion of regulatory submissions/notifications to maintain compliance with federal, state, and… more
- Eisai, Inc (Nutley, NJ)
- …Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with ... for and assures follow up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Eisai and… more
- Catalent (St. Petersburg, FL)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent ... Compliance ManagerPosition SummarySt. Petersburg is our primary softgel...readiness. Assess changes to GxP systems and data integrity regulatory requirements and communicate requirements to site leadership.Review and… more
- Tris Pharma (Monmouth Junction, NJ)
- …and clinical trial databases Ensures audit and inspection readiness of Drug Safety team at all times; Ensures internal regulatory /PV processes and ... procedures are well documented and support compliant regulatory /PV activities Reviews safety data exchange and/or PV agreements with appropriate business… more
- Merck & Co. (Rahway, NJ)
- …at the Rahway site.Integrates EHS programs into daily operations to assure regulatory compliance , continuous improvement and performance objectives are met ... Job DescriptionPosition Description: Specialist, Environmental, Health, and Safety (EHS) As a member of the Site...As a member of the Site Environmental, Health, and Safety (EHS) team, work collaboratively to ensure that compliant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Access Programs, Investigator initiated studies and Collaborative Research.Support adherence to regulatory safety requirements for all programs (ie post ... quality support across programs ensuring GCP, GPV, GDP, and adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact… more
- Merck & Co. (Rahway, NJ)
- …and proactively and result in outcomes that demonstrate the Company's commitment to regulatory compliance . Ensures that a cross-functional team (eg Quality & ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new… more
- Insmed Incorporated (Bridgewater, NJ)
- …different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards. Provide scientific ... lists.OverviewOverview The Director, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for quality ... risk-based assessment for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance team to ensure that GVP audits are planned, communicated and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(patient safety , rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance . Takes ownership to deliver upon near-term ... approvals to assure quality of the documentation files and compliance with NN SOPs, relevant regulatory requirements...files and compliance with NN SOPs, relevant regulatory requirements and ICH and GCP guidelines Provides support… more
- Merck & Co. (Durham, NC)
- …documents) to support project and ongoing operations. Identifies and addresses compliance , environmental, safety , and process deviations as appropriate while ... to troubleshoot and communicate appropriately and effectively Identifies and addresses compliance , environmental, safety , and process deviations as appropriate… more
- Catalent (Philadelphia, PA)
- …material management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA ... a Patient First culture through excellence in quality and compliance , and to the safety of every...Distribution Summaries/Checklists, and Returns Protocols (as required). Audit for compliance as pertains to Catalent SOPs, regulatory ,… more
- Merck & Co. (North Wales, PA)
- …success in the assurance of deliverable quality and process compliance .Ability to anticipate stakeholder and regulatory requirements.Preferred Experience ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Durham, NC)
- … - Responsible for creating and sustaining a culture that ensures that compliance ( Safety , Environment, cGMP, etc.) are imperatives for the business.- ... with a team of individual contributor production direct reports including safety , quality, and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of … more
- Merck & Co. (Millsboro, DE)
- … compliance with governmental regulations, and corporate/site policies including safety and biosafety.Utilize our systems such as Reliance, Atlas SRM, WorkDay, ... and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for… more
- Novo Nordisk Inc. (Phoenix, AZ)
- …(patient safety , rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and Closure) for assigned sites and clinical trials Verifies safety reporting and the proper handling, monitoring and storage… more
