- Merck (West Point, PA)
- …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 (West Point, PA)
- **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
- Taiho Oncology (Princeton, NJ)
- …to transforming the landscape of cancer treatment and improving patients' lives. As a Senior Director , Biomarkers and CDx Development, you will play a pivotal ... Sr . Director , Biomarker & Companion Diagnostic...companion diagnostic/assay development. + Extensive knowledge of the oncology drug development and device development process in… more
- Merck (West Point, PA)
- …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
- Merck (West Point, PA)
- …Our company is seeking a highly motivated candidate for the position of Director , Vaccine Drug Product Development. Vaccine Drug Product Development ... The Director will report to the Executive Director of Vaccine Drug Product Development, have...operational/ regulatory requirements for all dosage forms (liquid, lyo, drug - device combinations) + Review and approval of… 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
- 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