- Novo Nordisk Inc. (Plainsboro, NJ)
- … compliance with Service Level Agreements (SLAs) and Pharmacovigilance Agreements (PVAs) Compliance With FDA and Health Canada Reporting Regulations & Audits: ... health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …documents (eg, clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical ... health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support… more
- BioAgilytix (Durham, NC)
- …LIMS).Experience with ITIL-based processes and frameworks.Experience in regulated environments (eg, FDA , GMP, GDPR compliance , GAMP, etc.) and familiarity with ... accountability to deliver projects that meet technical, business, and compliance requirements.Additional ResponsibilitiesCompletes assigned tasks and projects effectively, completely,… more
- Merck & Co. (North Wales, PA)
- …Immunology, or PAH (Pulmonary Arterial Hypertension) experience.-Strong understanding of the compliance landscape, including FDA , OIG, and CMS regulations ... their lifecycles, offer structuring for copay programs, ensuring government compliance , managing high-impact vendor relationships, leveraging consumer data analytics,… more
- Tris Pharma (Monmouth Junction, NJ)
- …policies and current industry standards.Essential Job Functions: Carries out responsibilities in compliance with all cGMP, FDA , DEA, and OSHA regulations, as ... well as all applicable company compliance guidelines, policies, standards and objectives.Sets up and operates...UV/IR, HPLC, GC, TLC and dissolution apparatusWorking knowledge of FDA and cGMPs regulations and guidances as well as… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the ... various subunits of the Quality System and ensuring accountability. Achieving compliance with cGMP and other relevant regulatory requirements and fostering… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Title -Director/ Principal Scientist, Regulatory Compliance Department - Device Quality & Regulatory Brief Description of Position- This ... (GRACS). The primary responsibility for this position is to ensure regulatory compliance for the company's portfolio of medical devices and medical device… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the ... the efficient execution of critical quality tasks. Fostering efficiency, maintaining compliance with cGMP and other relevant regulatory requirements, and fostering… more
- Merck & Co. (North Wales, PA)
- …business objectives.Serve as the liaison and manages correspondence with FDA 's promotional review divisions Office of Promotion and Advertising ... use of study results in US promotion.Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, ... may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional representatives on… more
- Tris Pharma (Monmouth Junction, NJ)
- …Complaints (PQC) documentation, compliance efforts, quality operations, etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA , as well as all ... current Good Manufacturing Practices (cGMPs), Food and Drug Administration ( FDA ) standards and batch record specifications.The incumbent uses systems thinking… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively ... identifies compliance risks impacting research unit across DSG, and assures...place.Responsible to engage directly with Health authorities such as FDA , EMA, Swiss medic, and other local authorities as… more
- Merck & Co. (Rahway, NJ)
- …our company with external organizations through direct communication with the FDA , including telephone calls and e-mail; chair meetings between company and ... FDA ; prepare our company teams for meetings with ...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …our company with external organizations through direct communication with the FDA , including telephone calls and e-mail; chair meetings between company and ... FDA ; prepare our company's teams for meetings with ...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Upper Gwynedd, PA)
- …such as the United States of America Food and Drug Administration ( FDA ), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency, ... Contact (POC) for a specific area of regulations (eg FDA , EMA, NMPA, etc.). As such, the CQOM is...in outcomes that demonstrate the Company's commitment to regulatory compliance .Ensures that a cross-functional team (eg Quality & Continuous… more
- Merck & Co. (Rahway, NJ)
- …NDA, BLA, and MAA applications.Ensure that regulatory submissions meet the requirements of FDA , EMA, and other health authorities, while keeping up with the latest ... including participation in meetings, providing justifications, and responding to queries. Compliance and Continuous ImprovementDevelop and implement continuous improvement strategies… more
- Eisai, Inc (Dallas, TX)
- …responsibility of leading demand generation in a manner consistent with the FDA -approved indication to meet or exceed sales objectives. This will be accomplished ... conveying complex clinical information to customers and key stakeholders regarding FDA -approved indications of this novel therapy. The individual will implement and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Independently leads cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for FDA ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards ... and implement process improvements related to safety, environmental, quality, compliance , productivity, yield, and cost.Implement process improvements within the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …our company regulations and other global health authority regulators such as FDA . Will collaborate cross functionally to close nonconformance records and identify ... in preparation for and during internal and external regulatory audits (including FDA , EMEA).Support coordination of data collection and trend analysis as requested… more
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