- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- Merck (North Wales, PA)
- … Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical ... and follow-up of regulatory applications and ensure quality and compliance across all documentation. +...content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory … more
- West Pharmaceutical Services (Exton, PA)
- …the Sr. Specialist ensures timely and high- quality execution of all regulatory deliverables and ensures compliance with West and government requirements. ... compliance information and data as required for regulatory compliance and submissions to North America,...all times + Able to comply with the company's quality policy at all times + Able to work… more
- Globus Medical, Inc. (Audubon, PA)
- …renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance . Monitors and ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- Merck (West Point, PA)
- …data management. Required Skills and Experience: + Knowledge of manufacturing, testing, quality , and supply chain processes from late clinical development ... + Familiarity with CMC operations and technology transfer from late clinical development to commercialization (manufacturing, testing, quality , supply). +… more
- Philips (Reedsville, PA)
- …recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and ... confirm compliance and traceability. + Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission… more
- Bausch + Lomb (Harrisburg, PA)
- …reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance , regulatory intelligence and change ... US and/or Canada + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical...to product development teams and give guidance on potential regulatory compliance issues + Point of contact… more
- Penn Medicine (Philadelphia, PA)
- …reporting and monitoring of all aspects pertaining to pharmacy payer audits and regulatory compliance . + The Ambulatory Regulatory Technician is responsible ... pharmacy locations insurance audit requests, as well as proactive audits and regulatory compliance . The Ambulatory Regulatory Technician services more… more
- Penn Medicine (Philadelphia, PA)
- …Provides ongoing continuing education and skill validation of clinical staff. Quality , Patient Safety, and Regulatory Affairs: Partnership with the Vice ... mission. The SCD also partners with each entity to ensure departmental compliance with Regulatory and Infection Prevention Guidelines The SCD will… more
- Sumitomo Pharma (Harrisburg, PA)
- …and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop and ... of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory... study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with… more
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