- Merck & Co. (Rahway, NJ)
- …-scientific leader with expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D ... clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing… more
- Merck & Co. (Rahway, NJ)
- …global regulatory expectations of drug and vaccine development, including clinical trial design, clinical pharmacology, biomarker plans, and model-based drug ... approaches to enable drug-development decision-making from drug discovery through approval. Senior Specialists will work in collaborative teams and with more… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This is an ... oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence...and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The National Senior Director, US Field Medical is responsible for the direct leadership of the ... as a national medical and scientific resource to Insmed for planning, clinical insights, and intelligence!Serves as a national medical and scientific resource to… more
- Merck & Co. (Rahway, NJ)
- …and coach to the HF team and key stakeholders across R&D, clinical , regulatory , marketing, manufacturing, and quality functions.Educate and build awareness ... Job DescriptionThe Senior Director of Human Factors (HF) will provide...represent the company externally to influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence… more
- Insmed Incorporated (NJ)
- …of people and teamsProven ability to work within a multi-functional team (legal, regulatory , clinical /medical, quality, research , etc.)Able to multi-task and ... the future of science, we're in. Are you?About the Role:The Senior Manager, Global Medical Information will be primarily responsible for creating/updating/reviewing… more
- Aequor (Thousand Oaks, CA)
- …EU Medical Device Directive, EN 60601and IEC/EN 62304) Experience supporting pre- clinical , clinical research , and/or pharmacovigilance activities Ability ... Senior Specialist QA Remote any time zone OK...implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (eg FDA CFRs for Biologics and Medical… more
- Insmed Incorporated (NJ)
- …treating HS.Partner with Medical Affairs and Commercial Effectiveness to ensure key clinical and research insights inform HCP strategies.Lead development and ... other, and for the future of science, we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for our brensocatib program in HS (hidradenitis… more
- Formation Bio (New York, NY)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...to patients faster and more efficiently.About the PositionAs a Senior Data Engineer at Formation Bio, you will focus… more
- BeOne Medicines (Emeryville, CA)
- …site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ... ICH-GCP guidelines, local regulations, and applicable SOPs. The SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day to day clinical study… more
