- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may be… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Ensure program success by working cross functionally with R&D-Engineering, Marketing, Medical Affairs , Manufacturing, Quality and Regulatory Affairs . + ... Participate in intellectual property growth; submit patent applications and Invention Disclosure Records. + Works under general direction and independently determines or develops approach to solutions. + Adhere to Good Laboratory Practices, all relevant lab… more
- Vitalief (New Brunswick, NJ)
- …all functional areas within clinical research including: Study Start-Up & Regulatory Affairs (IRB/ethics submissions; Contract and budget negotiation, ... Feasibility assessments); Patient Recruitment & Enrollment; Clinical Operations / Study Coordination; Principal Investigator & Sub-Investigator Oversight; Data Management & Quality Assurance; Pharmacy / Investigational Product (IP) Management; and Laboratory… more
- Stryker (Mahwah, NJ)
- …records **What you need** **Required Qualifications** + Bachelor's degree in Regulatory Affairs , Engineering, Graphic Design, Technical Writing, or related ... teams and external partners to deliver high-quality documentation that meets global regulatory standards and enhances patient safety. To learn more about Stryker's… more
- Bristol Myers Squibb (Princeton, NJ)
- …Collaboration : Serve as the primary point of contact for internal (Medical Affairs , Development, Commercial, Regulatory Affairs , Legal, and Compliance) and ... Proven track record of successfully managing MAPs across a disease area. + Regulatory / Compliance Knowledge: In-depth knowledge of global and local regulations and… more
- Cardinal Health (Trenton, NJ)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. More specifically, this role serves the function to support… more
- J&J Family of Companies (Raritan, NJ)
- …including ensuring in-stream data quality from partners. + Work with colleagues in Regulatory Affairs to ensure that all relevant regulatory documents ... all assets within Heme, ensuring alignment with overall clinical development and regulatory activities. + Serve as the primary point of accountability for diagnostic… more
- Integra LifeSciences (Plainsboro, NJ)
- …from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs . + Project Management aimed to evaluate, analyze, ... technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct… more
- Robert Half Technology (Mahwah, NJ)
- Description We are looking for a dedicated Regulatory Affairs Quality Assurance Specialist to join our team in Mahwah, New Jersey. In this role, you will play a ... crucial part in managing document-related changes while ensuring compliance with regulatory standards for medical devices. This is a long-term contract position that… more
- AbbVie (Florham Park, NJ)
- …pharmaceutical brands and provide in-depth substantive advice to the Marketing, Medical Affairs , Market Access, and Regulatory Affairs departments concerning ... a broad range of legal, regulatory , and compliance issues. + Provide clear advice to business clients and senior legal management on core international and key markets' laws and regulations, focusing on areas of promotion, patient support, payer access,… more