- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThe Quality Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Program Leadership and Technical ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all activities are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …address regulatory requirements, and shape product development strategies Regulatory Compliance : Ensure early commercialization strategies comply with ... regulatory guidelines and industry standards, working closely with regulatory affairs teams to address any compliance -related issues Commercialization… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enhance TA-specific customer experiences; building strong cross-functional relationships; ensuring compliance to Legal, Regulatory and industry standards; ... Best Practices: Maintains strong understanding of omnichannel best practices, Marketing and Regulatory /Legal aspects to ensure compliance with legal, quality and… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process changes/improvement.Partner with all stakeholders to implement process improvements.Assure regulatory compliance and technical feasibility of proposed ... recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Will utilize prior academic experience to optimize resource allocation, ensure regulatory compliance , and uphold rigorous scientific standards. Understanding ... Regulatory Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to include the USDA, FDA, CDC, and other similar… more
- Merck & Co. (North Wales, PA)
- …and medical education programsMinimum 18 months of experience in US and ex-US Regulatory , Compliance and Risk Management aspects and ability to lead contracting ... with select professional and medical societies) that are in alignment with regulatory body governance and country-specific guidance, with the objective to improve… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enhance TA-specific customer experiences; building strong cross-functional relationships; ensuring compliance to Legal, Regulatory and industry standards; ... Maintains strong understanding of omnichannel best practices, digital spaces, Marketing and Regulatory /Legal aspects to ensure compliance with legal, quality and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …use of resources to ensure attainment of unit, department and Company profitability goals Compliance and Regulatory : Ensure compliance with regulatory ... in all marketing materials and promotional activities. Work closely with legal, regulatory , and compliance teams to review and approve promotional materials,… more
- Eisai, Inc (Exton, PA)
- …CTAs) and agency communications (responses to questions) are prepared in compliance with the applicable regulatory requirements and scientific ... Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the… more
- Merck & Co. (Rahway, NJ)
- …technology selection, clinical evaluation, early combination product development, and regulatory compliance . Position Qualifications : Education Minimum ... science, preclinical and clinical research.In-depth knowledge of medical device development, regulatory requirements, and quality standards, with a knowledge of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of post-law school experience required- 4 or More Years experience in regulatory , compliance , and legal matters relating to investigational products, product ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …into actionable marketing strategies to guide customer experiences Understanding of regulatory , compliance , and ethical considerations in engaging with ... with Commercial Excellence and Innovation, Therapeutic Area/Brand leads, Sales, Medical/Legal/ Regulatory , and IT. Essential Functions Roadmap Coordination and Execution:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and approval workflows within the DAM system to maintain content integrity and compliance with regulatory requirements. Stay informed about emerging trends and ... actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… more
- Eisai, Inc (Fort Worth, TX)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines.Strong knowledge of key laws and regulations ... working with appropriate Health Care Providers. Complete ongoing clinical acumen and compliance training with goal of being expert level for customers. Achieve sales… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …More Years of post-law school experience required- 7 or More Years experience in regulatory , compliance , and legal matters relating to pricing and Market Access ... legal issues pertaining to assigned business areas. Work collaboratively with Compliance colleagues to develop and implement training to internal clients, partners… more
