- Insmed Incorporated (NJ)
- …of Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance , Medical Affairs, Market Access, and ... commitment to working closely with patient community preferredFamiliarity/experience with regulatory and pharmaceutical legal promotional review processesA track… more
- Eisai, Inc (Baltimore, MD)
- …and system standards within the department to ensure reliability and compliance with company standards and governmental regulatory requirements. ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- Merck & Co. (Durham, NC)
- …our incredibly high standards of quality and meets all regulatory requirements. Partnering across our-internal manufacturing facilities, external contract ... processes through collaboration with-Production and Technical Operations.-Primary Responsibilities: Perform review of batch records and associated documentation. Provide quality… more
- Tris Pharma (Monmouth Junction, NJ)
- …negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory ... control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality, and regulatory standards in warehouse… more
- Merck & Co. (Rahway, NJ)
- …and analysis of clinical samples, both internally and with external vendors in compliance with the relevant regulatory and quality standards. Apply advanced ... to enable innovative strategies for clinical trial biomarker testing. Author and review internal technical reports including sections of regulatory filings (eg… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … review of manufacturing investigations, CAPAs, change controls and complaints. Review and approve manufacturing procedures.Support regulatory inspections and ... while ensuring high quality and complaint product supply.Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend… 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
- Novo Nordisk Inc. (Boulder, CO)
- …of technical teams required Experience working to standards required for regulatory compliance of Aseptic Processing facilities required Understanding of ... , Analytical Development, Materials Management, and Clinical Supply Write, review , and/or approve Standard Operating Procedures, specifications, regulatory … more
- Merck & Co. (Montgomery County, PA)
- …interactions and case management.Act as primary liaison with commercial, medical affairs, market access, legal/ compliance , pharmacovigilance, and external ... networks, patient advocacy groups, and third-party vendors.Partner with legal and compliance to review promotional and non-promotional materials, financial… more
- Merck & Co. (South San Francisco, CA)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)Provide clinical pharmacology… more
