- Insmed Incorporated (NJ)
- …of relevant guidelines including, but not limited to medical and regulatory affairs, drug development , FDA and regulatory guidelines (ie, PhRMA guidelines, OIG, ... the future of science, we're in. Are you?About the Role:The Senior Director , Medical Services will provide strategic leadership to Insmed's independent medical… more
- Merck & Co. (Rahway, NJ)
- …of relevant experience. Required Experience and Skills: Experience with small molecule drug substance and/or biologics process development and scale-up, moving ... Customer-Focused, Data-Driven Decision Making, Deviation Investigations, Driving Continuous Improvement, Drug Product Development , Estimation and Planning, Fast-Paced… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleGenmab is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an ... and work in a highly dynamic and collaborative setting.The Director , HEOL Team Lead is part of the US...providing the HEOLs with an individualized view of their development plans and ongoing performance. This is a remote… more
- Insmed Incorporated (NJ)
- …of R or other statistical software packages Significant knowledge of the drug development process, clinical trial methodology, and relevant regulatory ... Sets tasks, prioritization, and resources within assigned compound(s) Provides program -level programming leadership and support to clinical development … more
- Insmed Incorporated (NJ)
- …is preferred.Knowledgeable in all aspects of clinical operations, project management, the drug development process, and clinical trial conduct, including systems ... 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations. Ensures consistent and successful execution of operational… more
- Merck & Co. (Rahway, NJ)
- …Design Failure Mode and Effect Analysis (DFMEA), Design Verification Testing, Device Development , Diversity Awareness, Drug Development , Human Factor ... Development (DPPD) Team, which focuses on the design, development , and commercialization of novel biologic/ drug /vaccine-device combination products for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance considerations into research planning and execution across all phases of drug development Develop and maintain Patient Safety onboarding and ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations. This… more
- Merck & Co. (North Wales, PA)
- …assessment of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise ... role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in Philadelphia, PA or Somerset, NJ. Role OverviewWe are seeking a ... highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical...from early research through IND-enabling studies and into clinical development , ensuring regulatory compliance and scientific rigor in support… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Medical Director , Medical Affairs - Dermatology role will be responsible for supporting the product ... vision. This position will report directly to the Executive Director of Medical Affairs. Together with the Executive ...of medical advisory boards.Provide Medical Affairs support in the development of the asset development strategy, LCM/IIR… more
