- Merck (Rahway, NJ)
- …in technical transfer processes while aligning with the company's business objectives. The Senior Director will ensure device working groups and staff ... **Job Description** The Senior Director of Process Integration and...+ Minimum of 15+ years of experience in medical device or combination product engineering, with significant experience in… more
- Merck (Rahway, NJ)
- **Job Description** The Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and ... product stewardship for our company's medical device and combination products (approximately 15 in total). This...and statistically sound CAPA plans and issue resolution. The Senior Director will ensure stewards have the… more
- Sanofi Group (Bridgewater, NJ)
- … Technology will He / she will also support Director of Connected Device Technology will work closely with GDPU senior leadership, key representatives from ... ** Director of Connected Device Technology** **About...they meet the specific needs of the pharmaceutical and drug - device combination products. Accountable for the risk… more
- Merck (Rahway, NJ)
- …Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe ... and launches. **Principal Responsibilities** + Lead and set direction for the device development strategy for multiple drug - device combination product… more
- Integra LifeSciences (Princeton, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The Senior Director is responsible for leading the program management of Integra's ... and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical… more
- Bausch + Lomb (Bridgewater, NJ)
- …are seeking a dynamic and results-oriented individual to join our team as a ** Senior Director , Business Development** . The position reports into the SVP, Chief ... the ophthalmic industry. + Deep understanding of pharmaceutical and medical device product lifecycle management, including drug development, regulatory… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Global Medical Affairs Senior Director , Rhinology and Gastroenterology **Location:** Cambridge, MA **About The Job** We are an innovative global ... a patient-centric approach to development of medical strategy both for product and device development as well as possible services which can enhance the value… more
- AbbVie (Jersey City, NJ)
- …safety surveillance + Responsible for safety surveillance for pharmaceutical / biological / drug - device combined products + Lead and set the strategy for ... key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission - safety component + Apply current regulatory guidance as appropriate for safety surveillance and… more
- Stryker (Mahwah, NJ)
- …(https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Global Clinical ... division Global Customer Excellence, Global Commercial Excellence and Clinical Affairs senior leadership. + Ensures strategic alliances with physicians, key opinion… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global drug development and ... + Preferred experience includes reviewing, authoring, or managing components of both drug and device regulatory submissions. + Understands and interprets… more
- Integra LifeSciences (Princeton, NJ)
- …and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical ... patient outcomes and set new standards of care. **SUMMARY DESCRIPTION** The Director , Supplier Controls is the Compliance Master Plan (CMP) Quality Management System… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …on the east coast time zone. ASD's comprehensive laboratory services help drive drug development programs forward. Our purpose is to meet our clients' needs by: ... with key clients, including developing relationships with key leaders at senior levels across various disciplines including Procurement, R&D and Clinical… more
- OPEN Health (Parsippany, NJ)
- Senior Medical Writer, Medical Communications Job Summary Our Senior Medical Writers work as part of a multidisciplinary team (including medical director , ... and other materials requiring sound clinical judgment and excellent writing skills. Senior Medical Writers work on multiple projects simultaneously and manage their… more