- J&J Family of Companies (Guaynabo, PR)
- …health systems, integrated delivery networks, pharmacy benefit managers, medical groups, regulatory agencies, and advocacy organizations. Maintain a pulse on market ... sessions, workshops, and knowledge-sharing initiatives focused on market access trends, regulatory changes, and innovative approaches. Foster a culture of continuous… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …as part of a cross-functional team with members from marketing, sales, clinical, regulatory , medical affairs, quality , manufacturing, etc. + Able to manage ... Demonstrates knowledge to provide design documentation to support global Regulatory filing strategies. Applies basic statistical techniques and utilizes design… more
- Excellus BlueCross BlueShield (Rochester, NY)
- …and remediating allegations of FWA while adhering to compliance and regulatory requirements. Primary activities include substantiating referrals, case planning and ... to impacted parties, managing disputes, and collaborating with law enforcement and regulatory agencies. Essential Accountabilities: Level I + Functions as a clinical… more
- Aston Carter (Lebanon, TN)
- …industry standards. + PMP certification preferred. + Expertise in risk management, regulatory compliance, and quality systems. + Proficiency with project ... This role demands a seasoned project manager with extensive experience in regulatory compliance and the ability to lead cross-functional initiatives under tight… more
- Edwards Lifesciences (Charleston, WV)
- …including coaching and performance oversight. + Expertise in medical writing processes, regulatory requirements ( FDA , EU MDR), GCP, and ICH guidelines. + ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Medtronic (Lafayette, CO)
- …stakeholders-including upstream marketing, innovation delivery, R&D, clinical partners, regulatory affairs, and commercial teams-the Global Product Owner plays ... and scientific expertise to translate the strategic product vision into market-ready, high- quality medical solutions. + Partner with the head of product, upstream… more
- Edwards Lifesciences (Irvine, CA)
- …and analyze accurate date of regulatory reports for submission for the regulatory bodies (eg, FDA ) + Identify technical and data issues and collaborate ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Lilly (Stamford, CT)
- …medical vision and stay in sync with current regulations, laws, guidance (eg FDA , ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly ... collaboration with cross-functional partners including medical affairs, clinical operations, regulatory , statistics and data science to advance the oncology pipeline… more
- Amgen (Washington, DC)
- …opinion leaders. Participate and providing clinical input into safety and regulatory interactions. + Provide clinical/scientific input during the development and ... trial data + Participate in safety assessments + Participate in interactions with regulatory agencies + Author CSRs, publications and regulatory submissions +… more
- Editas Medicine (Cambridge, MA)
- …monitoring and reporting to ensure scientific rigor, meeting timelines, budgets, and regulatory compliance + Deliver high- quality safety reports to support ... through nonclinical development including managing GLP and non-GLP studies, and regulatory submissions + Familiarity with FDA /EMA/ICH guidelines and proven… more