- Penn Medicine (Bala Cynwyd, PA)
- …shape our future each day. Are you living your life's work? Summary: + The Clinical Documentation Review Specialist is responsible for collaborating with ... appropriate quality patient care and positive patient outcomes. Responsibilities: + Documentation Improvement: Reviews clinical documentation for compliance… more
- Merck (West Point, PA)
- … supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders. + Works directly ... Product and Clinical Finished Goods). + Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as… more
- Penn Medicine (Bala Cynwyd, PA)
- …implements regulatory standards and processes, including improving and maintaining regulatory clinical documentation standards. The Specialist will ... facilitate survey readiness and monitor for ongoing clinical documentation compliance. The Specialist ...develop plans for sustaining the improvements and compliance. The Specialist coordinates documentation review for… more
- Merck (North Wales, PA)
- … Trials Regulation of the European Union). + Responding to internal and clinical review comments on public disclosures; amending disclosures as appropriate and ... & Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in… more
- Globus Medical, Inc. (Audubon, PA)
- …of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval… more
- West Pharmaceutical Services (Exton, PA)
- …, regulations, technical standards, guidance documents, test reports, clinical /medical terminology, technical product information, and complex documents. + ... Sr. Specialist , Regulatory Project Management (Evergreen Posting) Requisition ID:...regulatory affairs (RA) team's priorities. + Manage the preparation, review , and submission of complex global regulatory filings, information… more
- Catalent Pharma Solutions (Malvern, PA)
- **Enterprise Data Integrations Specialist ** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... Delivery (OSD) business unit. On site we have our state-of-the-art laboratory, clinical , and commercial manufacturing plant for oral dose forms in addition to… more
- Insight Global (Malvern, PA)
- …One of our large pharmaceutical clients is looking to hire a Sr Quality Specialist to join the EQ team. The individual will provide QA support for TAR-200 ... the specific tasks required on a daily basis by the position are: Support, review /pre- review , and/or approve the following - -Batch record review -Quarantine… more
- Endo International (Horsham, PA)
- …from the local, contract manufacturing, filling, and packaging facilities. Quality Documentation /Reports Review + Contributes to preparation and/or review ... and timely and accurate completion of reported events. Quality Documentation + Contributes to preparation and/or review ...Quality Documentation + Contributes to preparation and/or review of annual product review and updates… more
- Globus Medical, Inc. (Audubon, PA)
- …of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and ... their lives as quickly as possible. **Position Summary** **:** The Quality Assurance Specialist (QAS) will work within the Quality Assurance department to provide … more
- Globus Medical, Inc. (Audubon, PA)
- …of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and ... annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and… more
- University of Pennsylvania (Philadelphia, PA)
- …University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC ... Clinical Research Unit (CRU) is instrumental in the development...working closely with the CRU Regulatory coordinators to manage, review and initiate trials to ensure competitive activation and… more
- St. Luke's University Health Network (Sellersville, PA)
- …assisted treatment (MAT) options with the client and documents recommendations with clinical rationale, the client's reaction and the plan for referral to the ... staff, if appropriate. 6. In conjunction with the client and aftercare specialist , develops a comprehensive discharge plan that includes therapeutic treatment for… more