- Sanofi (Swiftwater, PA)
- …support production, quality control, and data management. Deliverable Accountability: Ensure compliance with GMP and regulatory standards (C&Q), including ... teams to ensure alignment of automation systems with production goals and regulatory requirements. Compliance & Risk Management: Ensure that all automation… more
- AdaptHealth LLC (Philadelphia, PA)
- …execution while developing expertise in control evaluation, risk assessment, and regulatory compliance frameworks. Essential Functions and Job Responsibilities ... risk management processes, and governance frameworks to ensure organizational compliance and operational efficiency. Key responsibilities include supporting Sarbanes-Oxley… more
- Larimar Therapeutics (Philadelphia, PA)
- …achieve timely and efficient program submissions and approval, while ensuring compliance with applicable global regulatory requirements Evaluates proposed ... consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to… more
- Sanofi (Swiftwater, PA)
- …responsibilities. Establishing an annual audit program of third-party facilities to assess compliance with applicable regulatory requirements (GMP / GDP) and ... Third Party Management Specialist, you will ensure the quality and compliance of our pharmaceutical third-party partnerships by evaluating, qualifying, and… more
- Advanced Technology Services (Northumberland, PA)
- …Responsibilities: - Promotes and adheres to the ATS safety culture. - Ensures compliance with regulatory requirements and ATS policies and procedures. - Partners ... with internal/external customer for engineered solutions to improve reliability and throughput. - Identifies opportunities for Capital Expenditures for equipment replacement (develops and communicates ROI). - Highly knowledgeable in operating systems, critical… more
- Merck & Co. (North Wales, PA)
- …the US improve patient experience, treatment adherence, and outcomes while maintaining compliance with the highest ethical and regulatory standards.- The ... cross-functionally with global and ex-U.S. commercial, medical, access, policy, and compliance stakeholders to ensure that Therapy Patient Programs (TPPs) outside of… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.-The incumbent is responsible for… more
- Merck & Co. (North Wales, PA)
- …quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.Be ... fitness.Act as a key collaborator with statistical programming, statistics, regulatory and other project stakeholders.Responsible for PreNDA-and PreBLA-meeting preparation,… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (Montgomery County, PA)
- …collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will ... as primary liaison with commercial, medical affairs, market access, legal/ compliance , pharmacovigilance, and external partners to ensure integrated program… more
