- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Document Management Supervisor as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Document Management Supervisor will provide oversight of all GMP...GMP documents are cutting edge and incorporate all latest regulatory and quality requirements.Track relevant KPIsEnsure periodic review of… more
- Aequor (Thousand Oaks, CA)
- …degree and a minimum of 2 years of hands-on experience in document management, including workflow coordination and system administration. Proficiency with Viva or ... comparable document management platforms is required. Strong background in project...management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes… more
- Merck & Co. (Philadelphia, PA)
- Job DescriptionDescription The Associate Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety ... execution, and management of delivery of high quality and timely regulatory submissions.The responsibilities of the incumbent may include the following:Maintain… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement ... and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of ... PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly,… more
- Repligen (Waltham, MA)
- …supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, ... Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate risks… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and ... computer sciences, medical technology, business management, etc.-Responsibilities-Strong knowledge of document or training management systems. May also be involved… more
- Merck & Co. (Rahway, NJ)
- …and Technical Units, including external suppliers.As required, participate in Regulatory Agency inspection activities.As required, participate as CSV Subject Matter ... and understanding of recently published health authority guidance(s).Knowledge of regulatory trends and initiatives such as computer software assurance.Knowledge of… more
- Merck & Co. (Rahway, NJ)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make ... strong relationships with internal stakeholders, including commercialization, quality, analytical, regulatory , manufacturing, and Supply Chain to facilitate effective technical… more
- Twist BioScience (South San Francisco, CA)
- …You'll Be Doing Assist with writing work instructions and procedures, document control materials management, chage management, corrective action and preventative ... systems, and other company policiesPrepare for and participates in compliance auditsFollow regulatory and ISO 13485 requirementsWhat you will bring to the Team:BS in… more
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