- Merck & Co. (Rahway, NJ)
- …such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create and execute design ... execute, design verification strategies for assigned drug-device combination product program (s) for successful clinical introduction(s) and commercial market(s) approval(s).Define… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the centralized teams (eg, Training and Documentation, Quality, Supplier and Contract Management and Digital Enablement). The Director Patient Safety Data ... call handlers and external vendors supporting patient safety, customer Care and technical complaints. This role also encompasses indirect management of call… more
- Merck & Co. (Rahway, NJ)
- …with both upstream and downstream needs. They will ensure activities supporting these program deliverables are executed with technical rigor and drive risk ... in leading cross-functional groups both internally and externally - Demonstrated project management experience and ability to provide technical leadership for… more
- Merck & Co. (Rahway, NJ)
- …individual to work in a fast-paced job that provides a high degree of technical , project, and people management responsibility. - This SSO Facility Lead role ... the SSO Pilot Plant leverages significant depth and breadth of scientific, technical , and operational experience to lead and support facility operations, process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Europe, Canada, United States and Japan and may include other regions/ management units as needed to reflect changes to the business model.Responsibilities:Strategic ... and Human Resource Information System (HRIS) team to define/implement program functionality requirements for global HRISReporting and Improvement:Oversee the… more
- Eisai, Inc (Nutley, NJ)
- …MA Strategic Thinking, Mentoring/ People Development, Resource Planning & Management , Technical Breadth (Medical Affairs)Eisai Salary Transparency Language:The ... If this is your profile, we want to hear from you. The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive tactics… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Associate Director , Clinical Research Scientist will support and work predominately with the Medical ... and operations, regulatory and quality assurance teams, as well as overall program support ensuring the adherence to all standard operating procedures (SOPs).What… more
- Insmed Incorporated (NJ)
- …documents provided by Technical Operations or from CMOs to support development program and life cycle management , and ensure they meet current regulatory ... for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC post approval… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , EDC Programming will lead and oversee EDC programming, and database build for ... the subject matter expert (SME) for Medidata Rave, providing technical guidance and support to the team.Review software upgrades...7+ years of experience in EDC programming, configuration, and management of EDC systems, with at least 5 years… more
- Merck & Co. (South San Francisco, CA)
- …are seeking an exceptional and experienced leader in the role of Director , Antibody Screening and Characterization within the Discovery Biologics department at our ... South San Francisco site. The Director will be responsible for leading a team of...external advancements in relevant scientific fieldsIdeate and initiate new program concepts leading to pipeline programs in partnership with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …drives and manages an effective, holistic continuous improvement, problem solving and management program to improve process execution and system utilization of ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based… more
- Insmed Incorporated (NJ)
- …and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into ... and for the future of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination… more
- Insmed Incorporated (NJ)
- …analytical and problem-solving skills, particularly in the context of technical troubleshooting and investigation management .Effective communication skills, both ... for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all Quality… more
- Insmed Incorporated (San Diego, CA)
- …as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management , and external consultants to align regulatory ... 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
- Insmed Incorporated (NJ)
- …to join our dynamic Biometrics Medical Affairs team. The Associate Director of Medical Affairs Biostatistics is responsible for the statistical leadership ... decisions.Contribute to department and transversal initiatives, supporting organizational growth.Provide technical guidance and mentorship to junior statisticians.Who You Are:Ph.D.… more
- Formation Bio (New York, NY)
- …prediction, indication expansion, and asset prioritization Drive the Probability of Technical Success (PoTS) program and predictive modeling efforts using ... to bring new treatments to patients faster and more efficiently.About the PositionAs AD/ Director of Data Science - Platform at Formation Bio, you will lead one… more
- Insmed Incorporated (NJ)
- … technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formulation, manufacturing process, and device ... drug products worldwide with the flexibility for post-approval maintenance and lifecycle management of the marketed products.Develop plans for the preparation of CMC… more
- MetroPlusHealth (New York, NY)
- …to building strong relationships with its members and providers.Position OverviewThe Director of State Product Compliance, reporting to the Vice President of ... Compliance, plays an integral role in the oversight and management of product regulatory compliance activities, for State products offered by MetroPlusHealth… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:Reporting to the Director of Technical Operations, Project Management this position will be ... responsible for leading life-cycle management projects within the Technical Operations Department to successful and timely completion and hand-off to routine… more
- Insmed Incorporated (NJ)
- …a member of the Global Supply Chain & Logistics - Supplier Relationship Management team supporting the Technical Operations organization. The role will partner ... to influence and lead work groups. This position reports to the Director , Supplier Relationship Management .What You'll Do: Support supplier selection sourcing… more
