- Insmed Incorporated (San Diego, CA)
- …and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develops/provides input to product Benefit- ... time and in accordance with all relevant company and regulatory policies and procedures. In addition, the Senior...will be responsible globally for executing the safety and risk management activities. This individual is responsible for safety… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks Creatively advise ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director, Regulatory Affairs - Advertising & Promotion. Essential… more
- Genmab (Plainsboro, NJ)
- …and PMCs, etc. This responsibility will involve collaboration with a partner. Evaluate regulatory risk and recommend mitigation strategies to ensure optimal ... on the role for the assigned product Consult with senior management to develop and communicate regulatory ...request responses) as applicable, in markets within scope Drive compliance by providing guidance and advice to cross-functional teams… more
- Novo Nordisk Inc. (Durham, NC)
- …on shop floor Ability to support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues with little ... standards within the assigned process Provide coaching to Site regarding quality & compliance related activities Facilitate sharing of regulatory & compliance… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and… more
- Novo Nordisk Inc. (Durham, NC)
- …on shop floor Ability to support all processes & functions in Department Quality Risk Management Makes decisions on quality & compliance issues with little ... within the assigned process Provides coaching to Site regarding quality & compliance related activities Facilitates sharing of regulatory & compliance… more
- Formation Bio (New York, NY)
- …Oversee and perform batch record reviews to ensure accuracy, completeness, and compliance with regulatory requirements. Manage QA release of clinical trial ... execution of QA Audit Plans, Lead internal and external audits to assess compliance with regulatory requirements, track audit report responses, identify areas… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …laws and business tactics Champions a proactive approach to ethics and compliance , focusing on partnership, risk mitigation, prevention, and the advancement ... preferred A minimum of eight (8) years combined pharmaceutical, legal, regulatory , and compliance experience required OR a minimum of six (6) years' experience… more
- Novo Nordisk Inc. (Durham, NC)
- …Operate within compliance with a Quality Mindset that focuses on risk management & mitigation Implement effective Change Management Support Corporate, OFP, local ... process control systems to meet current & projected customer, business & regulatory requirements through the following activities: People Focus, Equipment Focus &… more
- Cytiva (Miami, FL)
- …Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance , and aligning with organizational quality ... about the Danaher Business System, which makes everything possible.As the Senior Manager, Site Quality you will collaborate closely with cross functional… more
