- Pfizer (Collegeville, PA)
- …contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports ... understanding of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-Clinical, Pharmacology, Quality Assurance. + Experience… more
- Merck (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
- Penn Medicine (Philadelphia, PA)
- …laboratory policies, procedure manuals and specified documents required for review by regulatory agencies. Ensures that all employees are kept up to date with ... these changes.Assists the supervisor in specified activities that ensure laboratory compliance with all accreditation agencies. Compliance with Competency accreditation guidelines is a staff responsibility that must be completed annually. May function as the… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, Global ... will be responsible for the development and implementation of world-wide regulatory strategies for projects in their assigned therapeutic area portfolio.… more
- Pfizer (Collegeville, PA)
- …Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional ... team. Strategic Guidance, Clinical Insights & Interpretation + Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and… more
- Pfizer (Collegeville, PA)
- …Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional ... in as committee members in joint collaborations. + Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications,… more
- Merck (West Point, PA)
- …vaccine bioanalytical outsourcing, ensuring alignment with corporate objectives and regulatory requirements. The Senior Director will oversee a multidisciplinary ... teams, including research and development, regulated bioanalytical, clinical research, regulatory affairs, and quality assurance, to provide scientific leadership… more
- Merck (West Point, PA)
- …Description** **Brief Description** **of** **Position** The Imaging Lead (Sr. Principal Scientist ) works with Clinical Imaging Scientists to support clinical trial ... aspects of the use of imaging, and oversees the work of the Clinical Imaging Scientist to ensure that timelines and deliverables are met and of high quality. The… more
- Lilly (Philadelphia, PA)
- …site is centered around the radiochemistry mission and is currently less than 100 scientist and administrative/support staff on a site that is limited in size but ... to help grow safety culture, manage risk and ensure adherence to regulatory requirements and Lilly internal standards. Representing Lilly Philadelphia site radiation… more
- Merck (West Point, PA)
- …and close-out activities + Upon invoicing, verify project deliverables with initiating scientist or manager and document status in audit-compliant manner, prior to ... working relationships with external stakeholders (eg CROs, academic institutions, regulatory agencies, in-sourced scientific services suppliers) as defined to… more