- Merck & Co. (Durham, NC)
- …strategic maintenance and reliability projects. The Mechanical Services Engineer Associate Director (AD) position will ensure reliable performance of equipment by ... Out/Tag Out (LOTO), Hazardous Energy Control Procedures (HECP)Collaborates with the Technical Center of Excellence (CoE) Reliability Engineers to conduct periodic… more
- 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
- Takeda Pharmaceutical (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions of ... and management ; understands relative strengths, weakness, and probabilities of technical success for the mitigation strategies proposed.The Sr Director /… 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
- Takeda Pharmaceutical (Boston, MA)
- …for developing solutions to identified risks and discussing with team and management ; understands probabilities of technical success for the solutions. ... in order to bring life-changing therapies to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative… 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
- Takeda Pharmaceutical (Boston, MA)
- …developing solutions to identified risks and discussing with team and management ; understands probabilities of technical success for the solutions.Accountable ... strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.Provides strategic and tactical… 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
- Takeda Pharmaceutical (Boston, MA)
- … enhancements Demonstrates strong skills with increasing independence in regulatory, program management , and technology development, such as understanding broad ... Head will be expected to collaborate cross-functionality with business and technical stakeholders, drive partnership with Regulatory Business Operations to drive… 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
