- J&J Family of Companies (Spring House, PA)
- …and Device Development and Regulation, Presentation Design, Program Management, Regulatory Affairs Management, Relationship Building, Research Documents, ... manage complex clinical trials, ensuring compliance with departmental, company, and regulatory standards. This role contributes to the clinical development plan and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business development initiatives. **Job… more
- Sumitomo Pharma (Harrisburg, PA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- AmeriHealth Caritas (Philadelphia, PA)
- …leadership of Keystone First, including the daily operations of Medical Affairs , Operations, Information Services, Quality, Marketing Regulatory and Legislative ... including Operations, Information Systems, Quality, Marketing, Human Resources, Medical Affairs , Provider Contracting, Regulatory and Legislative Affairs… more
- Organon & Co. (Plymouth Meeting, PA)
- …of industry experience in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... three years of experience in project management. + Proficient with MS Project, MS Timeline, and all Office products. + A working understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management. + Worked… more
- University of Pennsylvania (Philadelphia, PA)
- …review proposals for compliance with sponsor and University policies and ensure Regulatory Affairs requirements are satisfied and that Conflict of Interest ... the year. This allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with family-whatever your personal needs… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …a technical leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to ensure integrated quality ... practices. **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA, EMA, PMDA) and internal standards. + Support… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …actions (CAPAs). + **Stakeholder Engagement** : Collaborate with Clinical Operations, Regulatory Affairs , Pharmacovigilance, and other functions to ensure ... of clinical trial data and ensuring patient safety by verifying adherence to regulatory requirements and internal standards. As a key member of the Global Quality… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …+ Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs , and technical operations to ensure alignment ... systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement**… more