- Teva Pharmaceuticals (West Chester, PA)
- … regulatory guidelines and AMA style + Familiarity with drug development, therapeutic areas, and statistical concepts Job-Specific Competencies: + Excellent ... a difference with. **The opportunity** The Medical Writing Manager in Global Regulatory Medical Writing is responsible for writing and editing clinical regulatory… more
- Sumitomo Pharma (Trenton, NJ)
- …on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues. + Oversee ... and efficacy data. + Present at scientific, medical, and regulatory meetings globally. + Develop and maintain relationships with...INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …the approving Institutional Review Board, Emory University and applicable Food and Drug Administration (FDA) and other regulatory requirements. + Such activities ... Cooperative Group-sponsored trials by overseeing adherence to study protocols, regulatory requirements, and institutional guidelines. The Clinical Trials Monitor… more
- BrightSpring Health Services (Charlotte, NC)
- …within general resource and reimbursement models. Ensures compliance with regulatory requirements, including the proper delivery and documentation of services ... service sites deliver services in accordance with contractual, legal, and regulatory requirements + Implements/coordinates any necessary plans of correction from a… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame ... results and make decisions. The incumbent will represent statistical issues in regulatory agency meetings. The incumbent will lead the development and delivery of… more
- L2 Aviation (Erlanger, KY)
- …Must pass FAA/DOT drug screening and 10-year background check. Company Quality Policy : L2 is committed to quality and continuous improvement in all areas of our ... repair activities alongside the team when not engaged in inspection or regulatory responsibilities. The CI is responsible for oversight of inspection activities, … more
- Charles River Laboratories (San Diego, CA)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... required and advise management on safety and environmental issues. Review new regulatory standards and make compliance recommendations. + Inspect the facilities for… more
- Takeda Pharmaceuticals (Boston, MA)
- …stakeholders such as Clinical Operations, Clinical Biomarkers, Clinical Sciences, Oncology Drug Discovery and Regulatory Sciences to successfully deliver, ... diagnostics or IVD programs. + Have background in understanding of drug -diagnostic co-development and regulatory pathways. + Experience with biomarker-driven… more
- Banner Health (Gilbert, AZ)
- …narcotic medications following all federal and legal requirements as set through policy and procedure. Understands all regulatory requirements for receiving, ... preferred. **EEO Statement:** EEO/Disabled/Veterans (https://www.bannerhealth.com/careers/eeo) Our organization supports a drug -free work environment. **Privacy Policy :** Privacy … more
- Medtronic (Los Angeles, CA)
- …complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by ... regulatory agencies Review and analyze clinical databases for the...commitment to diversity here (http://www.medtronic.com) . It is the policy of Medtronic to provide equal employment opportunity (EEO)… more