- Catalent Pharma Solutions (San Diego, CA)
- …with at least five (5) years' of experience in Quality Assurance or Regulatory Affairs with progressive responsibilities; + Experience in managing people, ... Director of Quality Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and… more
- Ascendis Pharma (Palo Alto, CA)
- …clinical research resource for-cross-functional colleagues (eg in clinical operations, statistics, regulatory affairs , medical affairs , health economics ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe,...employees to grow and develop their skills. The Medical Director is involved in the design, monitoring, data analysis,… more
- Takeda Pharmaceuticals (Boston, MA)
- …with functional experts across the R&D organization, such QS, Research, Biostatistics, Regulatory Affairs , DMPK, Pharm Sci, and Clinical Science providing ... they value scientific excellence. + Represents Clinical Pharmacology in meetings with global regulatory agencies for his/her assigned programs. + Participates as… more
- Roche (Indianapolis, IN)
- …of the Scientific Strategy Director is done in close collaboration with the global research and development, regulatory affairs and US commercial and ... Join Roche, where every voice matters. **The Position** **Scientific Strategy Director (Cardiometabolism & Neurology)** **The Opportunity:** The Scientific Strategy … more
- ThermoFisher Scientific (Greenville, NC)
- …to producing compliant deliverables + Advanced, broad understanding of global /regional/national country requirements/ regulatory affairs procedures for ... trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory … more
- J&J Family of Companies (Cincinnati, OH)
- …Business Development, Medical Affairs , Clinical Research, Regional HEMA & Marketing, Regulatory Affairs , HCC and Legal. **You will be responsible for** **:** ... Posting Locations:** Cincinnati, Ohio, United States of America **Job Description:** ** Director , Health Economics and Market Access - Endomechanical and Energy**… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Clinical Subteams. + Partner with Medical Directors, Clinical Scientists, Regulatory Affairs , Preclinical Scientists, Statistical Programming, Data Management, ... is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development. This position requires an individual with a strong… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions + Coordinate interdepartmental ... the best of my knowledge. **Job Description** **About the Role:** The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …programs from initial feasibility through full-scale commercialization. + Partner with global regulatory (clinical and CMC) for developing combination products ... with evolving requirements across FDA, EMA, PMDA, and other global authorities. + In concert with CMC RA...advanced degree. Regulatory Expertise: Direct experience with global regulatory submissions and agency interactions for… more
- Amgen (Washington, DC)
- …the Director will work cross-functionally with Global Patient Safety and Global Regulatory Affairs and Strategy at the leadership level to optimize ... and transform the lives of patients while transforming your career. Director of Observational Research, Pharmacovigilance Epidemiology and Causal Inference **What… more