- Edwards Lifesciences (Portland, OR)
- …up. **How you'll make an impact:** + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior Manager, ... Medical Affairs ) is responsible for providing scientific expertise throughout the...the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations. + Experience with FDA PMA… more
- HRPivot (Tucson, AZ)
- …and clinical studies. + Partner with Regulatory Affairs and Clinical teams to support FDA PMA submissions and interactions with regulatory ... development of a highly advanced Class III medical devices through concept, preclinical, and clinical stages to FDA PMA approval. The ideal candidate has deep… more
- ThermoFisher Scientific (South San Francisco, CA)
- …**Job Description** **Location/Division Specific Information** This position is part of the Regulatory and Clinical Affairs organization which ensures that ... to develop our in vitro diagnostics is in compliance with Good Clinical Practice, applicable regulatory requirements (domestically and internationally) and is… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …of all products. Provides clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world as needed. + ... functioning in terms of leadership, compliance and productivity. The Director, Medical Affairs , will drive the clinical development and evidence generation plans… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …Processes; Clinical Development Tools and Processes; Medical Affairs Guidelines; Regulatory Guidelines; Pharmacovigilance Guidelines; Domains across ... pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US ( FDA regulatory... Affairs plans and Dr. Reddy's Canada Medical Affairs plans in consideration of best clinical … more
- J&J Family of Companies (Horsham, PA)
- …partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (eg Biostats, GCO, Regulatory Affairs , QA and QC) to ... and regulatory standards. This position resides in the Medical Affairs Gastroenterology Therapeutic Area (TA) Team which is responsible for developing,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …upholding medical affairs framework standards. + Ensure adherence to US regulatory and industry standards including FDA promotional guidelines, PhRMA Code, ... + Up to date on emerging global and US regulatory , clinical , ethical and compliance trends and...USMA framework. + Act as key liaison between Medical Affairs , Regulatory , Legal, Compliance and Commercial teams… more
- Lundbeck (Deerfield, IL)
- …for a rare disease + Past responsibility for managing IIT process + FDA regulatory knowledge and direct exposure **TRAVEL:** + Willingness/ability to travel ... Provide medical perspectives to internal stakeholders (Commercial, Market Access, Regulatory , Clinical Development, Pharmacovigilance etc.) ensuring clinical… more
- Astellas Pharma (Northbrook, IL)
- …and messaging for the brand + Collaborate with key stakeholders (eg Regulatory Affairs , Labelling, Pharmacovigilance, Commercial) to create competitive and ... optimized product labels aligned with regulatory requirements and market needs **Stakeholder Engagement:** + Build...progressive leadership experience in country, region or global Medical Affairs , Medical Safety or Clinical Development roles… more
- Lilly (Indianapolis, IN)
- …clinical experience, the Cardiovascular/Cardiometabolic Business Unit - Global Medical Affairs Clinical Research Physician (CRP) Senior/Executive Director is ... current local and international regulations, laws, guidance (for example, FDA , ICH, and CPMP etc.), Good Clinical ...the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies… more