- Merck (North Wales, PA)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of 8 years of relevant … more
- Bristol Myers Squibb (Princeton, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of… more
- Danaher Corporation (New York, NY)
- …with diagnostic tools that address the world's biggest health challenges. The Medical Director , Companion Diagnostics and Advanced Assays for Leica Biosystems is ... novel diagnostics. The role reports to the Senior Medical Director , Companion Diagnostics. If you thrive in...Matter Expert to direct R&D projects, clinical studies, and regulatory submissions in support of diagnostic and companion… more
- AbbVie (Mettawa, IL)
- …leader accountable for the creation and oversight of the execution of our Companion Diagnostics (CDx) Global Medical Affairs (GMA) objectives. + Oversees GMA ... the pharmaceutical industry and drug development. Experience in executional Medical Affairs roles, regulatory , HEOR, pharmacovigilance or clinical development… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.). + Identify and interact with key ... Global Project Team. In addition, he or she will interact with the Companion Diagnostics Lead, Non-Clinical Research, Medical Affairs and other stakeholders to… more
- AbbVie (North Chicago, IL)
- …or rheumatology highly desirable + Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics/in vitro ... and reporting of biomarker data/activities in line with the development, regulatory , and commercial strategies + Lead asset-specific translational projects/teams in… more