- ValSource, Inc. (Rahway, NJ)
- …used in the FDA regulated pharmaceutical and biotech manufacturing industries. Project Manager is responsible for managing and executing validation projects ... Project Manager ValSource is currently looking...validation and equipment qualification activities, and ensuring compliance with FDA , GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project… more
- Aptyx (Charlotte, NC)
- Project Manager (PM) is responsible for planning, overseeing, and leading projects from ideation through completion. This role requires interaction with a range ... of internal and external stakeholders, most often managing several moving project parts simultaneously. The PM role is responsible to plan and designate project … more
- Formation Bio (New York, NY)
- …Lead for clinical assets and associated studies. Step in as the Clinical Project Manager when needs arise. Operational Strategy and Leadership Develop and ... to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... Nordisk products and in compliance with Novo Nordisk and FDA requirements Responsible for Product Safety compliance across all...on all NNI websites and the CC Outlook box Project management- Coordinates department-wide projects and provides up to… more
- Insmed Incorporated (San Diego, CA)
- …simultaneously. Coordinate and lead validation activities with internal stakeholders and project team members. Author CSV Documents (Validation Plans and Summary ... Reports) Assist/co-author requirements, testing, specification, and other validation project deliverables Ensure training requirements are complete for project … more
- Insmed Incorporated (NJ)
- …Summary Reports) Assist/co-author requirements, testing, specification, and other validation project deliverables Ensure training requirements are complete for ... team members (CSV SOP, Test Execution, Gdoc. Etc.) Guide project team members on CSV projects ensuring team members...Veeva QualityDocs /QMSSolid working knowledge of CSV guidelines and FDA /EU regulations: 21 CFR Part 11, Annex 11, GAMP… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleThe Senior Manager , Clinical Programming is responsible for the establishment, governance, and integrity of Study ... knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements Demonstrated experience… more
- Cipla (Hauppauge, NY)
- …Ensure that the artwork complies with all relevant regulatory guidelines (eg, FDA , EMA) and industry standards, including proper labeling, dosage information, and ... maintained in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings for a Therapeutic Area in… more
- Cipla (Hauppauge, NY)
- …- 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this role performs and ... scale-up, engineering and validation studies, and assurance that the necessary project documentation is complete, accurate and in compliance with cGMP regulations.… more
