- Merck (West Point, PA)
- …mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen ... challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors. Conducts options analysis and provides… more
- Merck (West Point, PA)
- …transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group ... process demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP CMC sections of filing.… more
- Penn Medicine (Philadelphia, PA)
- …provides strategic leadership and direction regarding clinical, financial, regulatory , quality, human resources, and patient/employee satisfaction aspects of ... appropriate manner to maintain thorough records in compliance with regulatory and insurance requirements. + Collect and manage outcome...Work or Counseling (Required) + Ph.D. Doctorate Degree in ( PhD or PsyD) (Preferred) + 5+ years Post graduate… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care Compliance. **Job Duties** ... CFR Part 803, 806, 820) + Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs) + Corrective Actions -… more
- Merck (West Point, PA)
- …global auditing team + Maintain up-to-date knowledge base with respect to emerging regulatory trends and changes in regulations and standards to incorporate into the ... + Provide updates to company stakeholders on GxP and regulatory trends as well as the auditing program's ability...GMP regulated environment + Expert knowledge of GMPs and regulatory requirements and expectations. + Strong technical background +… more
- Merck (West Point, PA)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... and interpretation of data. + Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and… more
- Merck (North Wales, PA)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Pfizer (Collegeville, PA)
- …supports other critical documents, eg, protocol amendments, investigator brochure, and regulatory documents. + Collaborate with Clinical Operations to ensure timely ... strategy and/or data, and may assist with authoring clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR). + Support and assists… more
- Pfizer (Collegeville, PA)
- …investigator brochures, clinical study reports, statistical analysis plan, and regulatory documents. + Provide leadership to early stage clinical scientists ... with other clinicians, statisticians, clinical pharmacologists, translational biologists and regulatory specialists. Meet regularly with the Pfizer Oncology group… more
- Merck (West Point, PA)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more