- Merck & Co. (Rahway, NJ)
- …Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe ... product development and launches.Principal ResponsibilitiesLead and set direction for the device development strategy for multiple drug - device combination… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Medical Digital Health Lead, Sr . Director plays a pivotal role in closing care gaps through Medical digital innovation. This individual ... Medical Digital Health portfolio (eg, Software as a Medical Device ) This role will work in close collaboration with...medical risk & benefits analysis which are presented to senior leadership for discussion and funding decisions. + Develop… 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
- 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
- Merck (Rahway, NJ)
- …and inclusive work environment. **Essential Knowledge, Duties & Responsibilities for the Director Include:** + Sterile drug product development concepts, tools, ... and requirements for all dosage forms (liquid, lyo, drug - device combinations) + Review and approval of data and technical documents + Ability to recruit, select,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …performance and quality metrics and share with study team, Operations Program Lead, and Sr . Director for the compound, on regular basis and ensure actions are ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- AbbVie (Jersey City, NJ)
- …safety surveillance + Responsible for safety surveillance for pharmaceutical / biological / drug - device combined products + Lead and set the strategy for ... Job Description Purpose: Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and PST leads… 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
- Abbott (New York, NY)
- …products for treatment of vascular disease. Our extensive portfolio includes drug -eluting stents, bare metal stents, guide wires, balloon dilatation catheters, ... Account Manager will work with, and report to, the Regional Sales Director to identify/evaluate market opportunities, business potential, and to achieve annual sales… more
