- Gilead Sciences, Inc. (Chicago, IL)
- …for information, consistent with promotional compliance, PhRMA guidelines, and FDA regulatory requirements. Implement defined goals and objectives aligned with ... the Medical Affairs Plan of Action and other strategic initiatives for PBC, HCV and HBV. Develop strategic plans for cultivating and maintaining working relationships with existing and future thought leaders in the assigned region. Provide timely insights to… more
- Mikehudsondist (Baltimore, MD)
- …This role oversees HACCP and Food Safety programs, ensuring adherence to USDA, FDA , and customer standards while supporting continuous improvement in food safety and ... product quality. This also includes change management implementation to ensure that all quality assurance programs meet applicable regulations and standards. What you'll do Establish and maintain the Corporate Food Safety and Quality Policies as well as… more
- Cedent Consulting Inc. (Dallas, TX)
- …functions strongly preferred. Familiarization with drug development process, FDA , ICH, and GCP guidelines. Experience implementing, monitoring, and/or ... managing clinical trials for academic clinical research or pharmaceutical/biotechnology company a plus. Knowledge and Skills Ability to review and interpret clinical data. Ability to develop clinical data and medical content for presentation to internal and… more
- Ipsen Group (Cambridge, MA)
- …Neuro drug development experience is highly desired.* Regulatory submission (US FDA , EMA, PMDA) experience is highly desired.Education / Certifications (essential):* ... PhD in Statistics, Biostatistics, Mathematics, or a related quantitative field.Language(s) (essential):* Fluent in English, with excellent verbal and writtenIpsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate,… more
- TechDigital Group (Summit, NJ)
- …and concurrently monitor tasks with others that may impact timely completion Knowledge of FDA / EU / PDMA / IGJ, GxP environments, ISO, and associated compliance ... regulations Adept in Microsoft Office Suite - Word, PowerPoint, MS Project, Excel, Outlook, and Visio with the ability to learn new software, such as enterprise business, building management, and security Proficient at writing well-formulated emails and… more
- General Dynamics Information Technology (MD)
- …Owner SME** to lead critical projects for the **Food and Drug Administration ( FDA )** . This role emphasizes program and product management by balancing high-level ... improvement, and product management to deliver results that meet FDA 's critical mission objectives. By engaging with customers and...tracking tools like JIRA. + Experience working with the FDA . + Ability to obtain Public Trust clearance. **Desired… more
- Medtronic (Santa Rosa, CA)
- …connected, compassionate world. **A Day in the Life** Medtronic is seeking an FDA /Life Sciences paralegal as a member of the Enterprise Legal Regulatory (ELR) team ... environment. This position reports to the Senior Program Manager- FDA /Life Sciences, Enterprise Legal Regulatory. This will be an...years of experience **NICE TO HAVE:** + Experience with FDA and FTC advertising and promotion regulations + Medical… more
- Parexel (Nashville, TN)
- Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to ... join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs… more
- DRT Strategies, Inc. (Arlington, VA)
- …qualification, and strategic capture of new business opportunities with the HHS/ FDA . This includes driving the end-to-end capture lifecycle: market research, ... process. + Demonstrable, hands-on success with business development for the FDA Preferred Experience: + Completion of government business development and capture… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- This position with the Regeneron Regulatory and Commercial Law team will provide proactive and collaborativeetc. **Salary Range (annually)** $238,400.00 - $397,300.00 ... legal advice and counsel in connection with the commercialization of one or more of Regeneron's products, and be part of a legal team supporting cardiovascular, hematology, rare disease, oncology, obesity, and new products. Counsel will be embedded as a core… more
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