- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... track for experience in Advertising and Promotion. The fellow will learn about FDA regulations, including compilation and submission of any required documents to … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... and the management of contracts with safety reporting requirements. Key contact person for FDA and Health Canada PV inspections and device inspections as well as key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to ... implement US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... As assigned, participate in project teams Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents Assume… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …etc.).Develop less complex Module 1 regulatory documents (eg cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory ... submissions.Support FDA meeting preparation including preparation of briefing document, meeting...including preparation of briefing document, meeting request, response to FDA preliminary comments and logistics.Support FDA meeting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to ... regulatory strategy for assigned project(s). Strategize and plan for FDA meetings.Serve as the primary contact with FDA... FDA meetings.Serve as the primary contact with FDA and liaise, negotiate and orchestrate meetings and teleconferences… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Independently lead cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategize and plan for FDA ... Independently leads cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for FDA … 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 FDA at any phase of drug developmentLead cross-functional efforts to prepare for advisory committees and may… 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 FDA at any phase of drug development. Lead cross-functional efforts to prepare for advisory committees and may… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and this position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position ... documents where necessary with supervision.Health Authority Interactions: Leads US FDA /EU EMA interactions with support from higher-level manager.Regulatory Knowledge:… more
- Tris Pharma (Monmouth Junction, NJ)
- …current Good Manufacturing Practices (cGMPs), Food and Drug Administration ( FDA ) standards and batch record specifications.The incumbent uses systems thinking ... efforts, quality operations, etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA , as well as all applicable company compliance guidelines, standards… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical communications; responses must be… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …interpret, and report data. Must have knowledge of Good Laboratory Practice Guidelines ( FDA , OECD, EPA). Preference will be giving to individuals who have experience ... in a regulated setting ( FDA , GCP, etc.) and with management of projects. Requires strong written and verbal communication skills, the ability to work independently… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …a uniquely Exela's way. Job Responsibilities: Drafting, editing, and reviewing FDA -issued regulations and Guidance documents, as well as internally developed ... Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the Quality Department in developing and… 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, ... be assigned as Point of Contact (POC) for a specific area of regulations (eg FDA , EMA, NMPA, etc.). As such, the CQOM is responsible for monitoring, interpreting and… 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 ... global quality system and regulatory requirements for combination products, including FDA , EMA, and other health authority guidelines.Strong understanding of ISO… more
- Lundbeck (Boston, MA)
- …and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... healthcare economy and industry practices. Accountability and adherence to corporate, FDA , and PDMA guidelines.REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategies are in place.Responsible to engage directly with Health authorities such as FDA , EMA, Swiss medic, and other local authorities as necessary to address ... Clinical Development activities (ie , protocols) are aligned with GLP/GCLP, FDA , ICH, EMA, PMDA regulations/ standards and guidance.Identify QA compliance issues… 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
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