- 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
- Pfizer (Collegeville, PA)
- …conduct, and analysis. They work closely with other functions such as regulatory affairs, pharmacovigilance, biostatistics, and medical affairs to ensure that the ... clinical development program meets the scientific, ethical, and regulatory standards. They also provides medical expertise and guidance to the clinical operations… more
- Philips (New Kensington, PA)
- …and inspections related to C&R requests, aids in strategy development, oversee regulatory inquiry responses, and reviews these responses to ensure compliance with ... the process, including complaint handling, engineering change orders, kit suppliers, regulatory submissions, and field deployments. + Provides pertinent feedback and… more
- J&J Family of Companies (West Chester, PA)
- …closely with R&D Teams and life-cycle management, including management of regulatory documents, critical evaluation of clinical risk and input regarding potential ... the Innovation leaders: Global Strategic Marketing, New Business Development, R&D, Regulatory , Clinical, Quality, & Supply Chain leveraging deep medical expertise.… more
- Humana (Harrisburg, PA)
- …both ASC 740 and SSAP 101, supporting our financial integrity and regulatory obligations. The ideal candidate will bring deep technical expertise, strong leadership, ... (ETR) forecasting and analysis process. + Partner with external auditors and regulatory bodies to support audits and examinations. + Ensure appropriate internal… 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
- Saint-Gobain (Malvern, PA)
- …Products and Chemicals North American products sites. + Provide regulatory and Hazard Communication support to fulfill requests/inquiries for Construction ... ensure that the company's manufactured products' SDS and labeling reflect current regulatory requirements. + Maintain up to date knowledge of country and… more
- PNC (Pittsburgh, PA)
- …policies and procedures accurately reflect current laws, rules, other regulatory requirements and management intent. Independently challenges analyses, reviews and ... and Sanctions risk and internal controls. Researches AML and Sanctions regulatory developments. Assists, as appropriate, in updating or implementing new/enhanced… more
- Guthrie (Sayre, PA)
- …across core domains: + Clinical Research Operations in compliance and in regulatory areas. + Supports research and scholarly activities related to Graduate Medical ... + Minimum 3-5 years of direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the FDA, NIH, or HHS. + Minimum 5 years of… more
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