- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The Position The Specialist, Regulatory Operations - Submissions supports the development of submission plans created ... submissions to FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal departments on … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(June through August) Preferred Skills: Interest in regulatory labeling operations and process optimization. Experience with project coordination or ... around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer 2026. This full-time… more
- Merck & Co. (Rahway, NJ)
- …Affairs Management, Regulatory Compliance , Regulatory Documents, Regulatory Labeling, Regulatory Operations , Regulatory Submissions, ... Job Description Associate Director, Regulatory Submissions Archive Operations - Location:...and implement user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal… more
- Merck & Co. (Rahway, NJ)
- …late clinical development through commercialization, with practical insight into how these operations generate CMC regulatory content Understanding of CMC ... operations , technology transfer, control strategy development, and regulatory authoring requirements that inform automated filing generation Hands-on experience… more
- ValSource, Inc. (Rahway, NJ)
- …and ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead ... Verifications and system walkdowns to confirm systems meet design and client specifications. Regulatory Compliance : Ensure compliance with all relevant … more
- Syner-G BioPharma Group (Boston, MA)
- …expertise to streamline operations , enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and deliver ... automation systems.Maritime facilities background (preferred).Familiarity with GMP environments and regulatory compliance (preferred).LEED certification, PE license, or… more
- Merck & Co. (Rahway, NJ)
- …Collaboration: Work closely with cross-functional teams (medical affairs, communications, regulatory , GEMs etc.) to ensure alignment and compliance ... Project Management, Innovation Projects, Knowledge Management, Leadership, Legal Compliance , Life Science, Medical Affairs, Medical Communications, Medical Knowledge,… more
- Formation Bio (New York, NY)
- …nursing, pharmacy, or a related field. Minimum of 10 years of clinical project management/clinical operations experience, including at least 5 years in a ... to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the… more
- Merck & Co. (Durham, NC)
- …team members in executing smaller improvement projects in their operational area- Represent Operations on project teams as needed- - Communication- Lead and ... Management Process, Manufacturing Processes, Manufacturing Quality Control, Operational Excellence, Operations Management, Organizational Compliance , Packaging Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance & Operations department brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance & Operations works closely across the organization to guide enterprise-wide...as well as Inflation Reduction Act ("IRA") processes and compliance activities for the Medicare Drug Negotiation Program. Ensures… more
