- Merck & Co. (Rahway, NJ)
- …leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production with respect to device ... applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director/ Associate Director/ Lead Regulatory Scientist/Sr. Manager ... related experience; including hands on related pharmaceutical or medical device /pharmaceutical combination product experience and actual regulatory experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …awareness of best practices for reproducible data science, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)- Ensure ... AI/ML deliverables- Contribute, with limited supervision, to documents submitted to regulatory or pricing authorities- Proactively identifies and manages risks in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert ... to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines. Responsible,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Head RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality ... Oncology and Specialty Medicine portfolios, in alignment with the business strategy. Lead the PV inspection management activities by ensuring readiness, compliance,… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Device Regulatory Lead ( Associate Director)** + Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global ... thought was possible. Ready to get started? **Main responsibilities** + Serve as Device Regulatory Lead on assigned project teams (early phase, late stage… more
- Merck (Rahway, NJ)
- …current in relevant worldwide regulatory guidance and standards. + Lead /support/oversee clinical supplies production with respect to device component ... lead cross-functional development teams within and external to Device Development. The incumbent must be able to work... Working Group to ensure full integration of the device development activities with the clinical, regulatory ,… more
- Sanofi Group (Bridgewater, NJ)
- …the job** The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs) for products in the Rare Disease, ... **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs** + Location: Bridgewater, NJ or Cambridge, MA **About… more
- Sanofi Group (Bridgewater, NJ)
- …the job** The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs ... **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About… more
- Novo Nordisk (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director/ Associate Director/ Lead Regulatory Scientist/Sr. Manager ... related experience; including hands on related pharmaceutical or medical device /pharmaceutical combination product experience and actual regulatory experience… more
- IQVIA (Queens County, NY)
- …to subject/patient recruitment and on time high quality data collection. The Clinical Lead provides leadership of the clinical team, in support of the project ... for Request for Proposals (RFPs). + Participate in bid defense preparations. Lead the Clinical delivery strategy at bid defense presentations in partnership with… more
- Novo Nordisk (Princeton, NJ)
- …preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Associate Director will ... high level strategic input into development plans, study designs, and regulatory submissions. Relationships The Associate Director, Medical Writing (ADMW)… more
- Integra LifeSciences (Plainsboro, NJ)
- …help improve outcomes. The ** Lead Quality Inspector** serves as a Lead Associate , Quality Inspector for the Plainsboro Manufacturing Site, Collagen ... Manufacturing Center (CMC). The lead associate is responsible for performing and/or...policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory … more
- Zimmer Biomet (New York, NY)
- …respected, empowered, and recognized. **What You Can Expect** The Program Associate Director will oversee lifecycle management business processes to enable the ... key functional areas - Research, Business Development, Finance, Clinical, Commercial, Legal and Regulatory . + Analyze the data related to the portfolio as owned by… more
- Guidehouse (New York, NY)
- …practice is an engine of innovation, helping pharmaceutical, biotech, medical device , and diagnostic companies develop custom solutions that tackle today's ... all levels, to deliver product planning, pricing, reimbursement, product commercialization, and regulatory and compliance solutions. Do you think you are up for the… more
- Kohler Co. (New York, NY)
- …Our mission is to build new digital businesses that empower consumers to lead healthier lives. We explore how familiar experiences can be enhanced and innovations ... a Quality Culture that will transform the company into a premier wellness device manufacturer. The ideal candidate will have demonstrated a successful track record… more
- Medtronic (New York, NY)
- …is assigned to the business unit. + Develop and maintain therapeutic and device operation knowledge; apply this knowledge to the development of well-written, clear, ... analyze literature search results + Address deficiencies and or answer questions from regulatory agencies as needed + Create and manage project schedule for each… more
- Terumo Medical Corporation (Somerset, NJ)
- …part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations ... by meeting all internal and external requirements. In this role, the associate will apply project management techniques to ensure projects are completed on-time… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Global Head RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality ... and Specialty Medicine portfolios, in alignment with the business strategy. + Lead the PV inspection management activities by ensuring readiness, compliance, and… more
