- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business.- - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point ... & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs...MS/MBA preferred. At least 8 years of experience in project management. At least 5 years of experience in… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in...or downstream areas) or manufacturing is required; ability to project achievable project plans to ensure effective… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
- Insmed Incorporated (San Diego, CA)
- …diseasesPrior experience serving as the regulatory lead on cross functional teams ( CMC , clinical and project teams)Ability and experience in the development ... and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where… more
- BeOne Medicines (San Mateo, CA)
- As Director of R&D Data Enablement / Data Products, you will lead the strategy and execution of building and scaling R&D data foundations and data products that ... By collaborating with stakeholders across Research, Clinical, Safety, Regulatory, Portfolio & Project Management and other R&D functions, you will ensure data is… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **:** The Manager, Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving ... guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC , and Regulatory Technology teams. While Regulatory Operations manages… more
- CSL Behring (Waltham, MA)
- …delivery teams. May lead discussion at Global Regulatory Forum (GRF) or with senior management on projects. -Lead GRA project deliverables (eg, Core Briefing ... and create greater impact for patients. With a streamlined, project -led structure and a focus on collaboration, we're building...a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? The job is… more
- Lilly (Indianapolis, IN)
- …creative solutions to support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will ... CMC scientific and technical leaders with accountability for technical deliverables. CMC Project Management is the program and project management arm of… more
- Lilly (Indianapolis, IN)
- …life-changing new medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - ... CMC commercial solid oral products will use ...strategies in collaboration with other regulatory, manufacturing, quality and project personnel to enable timely completion of submission milestones… more
- Boehringer Ingelheim (Ridgefield, CT)
- …is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... DP-related activities within the project (s), in support of CMC development within EACD. The Associate Director / Senior Associate Director of EACD for… more
