- Pfizer (Collegeville, PA)
- …is up-to-date and integrated into key commercial systems. + **Data Accuracy and Compliance ** : Ensure that all data management processes comply with regulatory ... processes, ensuring smooth transitions and adoption by relevant teams. ** Compliance and Data Security** + **Data Compliance **...** : Ensure oncology data management processes adhere to regulatory guidelines such as HIPAA, GDPR, and other data… more
- Penn Medicine (Lancaster, PA)
- …variety of pharmacy records, to promote efficient operation of the pharmacy and regulatory compliance . + Answers telephone using appropriate etiquette by the ... with the dispensing, charging and delivery of medication to patients, in compliance with department policies and procedures that provide optimal pharmaceutical … more
- Merck (West Point, PA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... tools and framework for driving Go/No Go decisions on programs and rapid regulatory approvals + Foster collaboration within QP2 to achieve results, remove barriers… more
- Merck (West Point, PA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... analyses + Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory … more
- Merck (West Point, PA)
- …record of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. + Educational ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Cytel (Harrisburg, PA)
- …and a strong understanding of statistical programming within a biotech or pharmaceutical environment. The ideal candidate will contribute to the maintenance of ... Listings, and Figures (TLFs) using SAS. Familiarity with GxP standards for regulatory submissions is essential. + Develop and maintain open-source software platforms… more
- Merck (North Wales, PA)
- …on programs. + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics (monoclonal antibodies, antibody ... drug conjugates, T-cell engagers, bispecifics) in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical… more
- University of Pennsylvania (Philadelphia, PA)
- …reviews, amendments, and adverse event reporting. + Prepare and process all regulatory documentation with pharmaceutical companies and CROs. + Obtain the ... CVs and medical licenses, record of IRB certification and compliance ). + Resolve regulatory related queries with IRB, study sponsors and CROs. Qualifications… more
- Sanofi Group (Swiftwater, PA)
- …and bring hope to patients and their families. This position ensures Quality Compliance oversight with cGMP, Regulatory , and Internal requirements regarding the ... and approval for SOPs, SWIs, and Master Manufacturing Records to ensure compliance with cGMP, regulatory and internal requirements. + Interact successfully… more
- Merck (West Point, PA)
- …Description** Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Under the ... work, understood capacity of management systems, and maintaining and improving compliance within the work order management process. **Position Responsibilities:** +… more