- Catalent (St. Petersburg, FL)
- …capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug ... Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving… more
- Merck & Co. (South San Francisco, CA)
- …on uncovering novel biology in immuno-metabolism to deliver a high-quality drug discovery pipeline.We are a research-driven biopharmaceutical company. -Our mission ... therapeutic strategies for immuno-metabolic diseases and build a robust pipeline of drug discovery programs.Serve as a core member of the Discovery CMD leadership… more
- Insmed Incorporated (Bridgewater, NJ)
- …Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments. The incumbent will ... and national standards, regulations, and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative. ResponsibilitiesAdditional representative responsibilities… more
- Aequor (Thousand Oaks, CA)
- …writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications Serve as functional area lead on ... Qualifications: Experience leading writing activities for new or supplemental drug applications/biologics license applications is strongly preferred Experience with… more
- Merck & Co. (Rahway, NJ)
- …advice to stakeholders creating optimal development, commercialization, and drug /delivery device supply strategies-Building our leadership and functional capability ... regulatory activities with cross- product or cross-functional impact, including drug device/combination products and software-as-medical device platforms.- Reviews and… more
- Merck & Co. (North Wales, PA)
- …Outlook, etc.)Education/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experienceOR ... Master's Degree +3 years of pharmaceutical, clinical drug development, project management, and/or medical field experienceOR PhD/PharmD DegreeDegree in life… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical evaluation reports (CER) Pediatric investigational plans (PIP) Orphan Drug applications Breakthrough Therapy Designation requests Clinical summary and ... and punctuation Demonstrated understanding of clinical research principles and the drug /device development process Keen attention to detail to ensure the accuracy… more
- Insmed Incorporated (Bridgewater, NJ)
- …and bills of material in ERPDSCSA ComplianceDemonstrate expertise in the Drug Supply Chain Security Act (DSCSA) requirements.Implement and oversee compliance ... as oversee multiple 3rd Party SuppliersSolid understanding of the commercial drug supply chain from raw material suppliers through distributionSkilled in scenario… more
- Catalent (MA)
- …in global supply chain and clinical supply management that will speed your drug to market.This position is for an Account Director position within the company, ... holidaysCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving… more
- Merck & Co. (Rahway, NJ)
- …of actions.Experience in analysis of various Biologic modalities (eg, mAb, antibody- drug conjugate, fusion protein).Knowledge and experience in Antibody Drug ... Conjugate method development.Established scientific reputation supported by publications and external presentations.Strong external network to benchmark competitors and equipment vendors.Experience in high-throughput experimentation and data-rich… more
