- Cardinal Health (Harrisburg, PA)
- …hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas, ... of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs. **Responsibilities:** + Collaborate across multiple functions and… more
- Merck (West Point, PA)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make ... strong relationships with internal stakeholders, including commercialization, quality, analytical, regulatory , manufacturing, and Supply Chain to facilitate effective technical… more
- Cytel (Harrisburg, PA)
- …model-informed drug development), to provide strategic advice to define optimal regulatory , clinical and/or market access pathways and promote faster patient access ... recognized thought leader and strategic advisor in the areas of optimal regulatory , clinical development and/or market access pathways and quantitative strategies to… more
- Teva Pharmaceuticals (West Chester, PA)
- …assays. This role requires close collaboration with cross-functional teams to support regulatory submissions. This role reports to the head (Senior Director) of ... teams in a professional and positive manner. + Deep working knowledge of regulatory guidance and quality standards; experience authoring and reviewing regulatory … more
- J&J Family of Companies (Spring House, PA)
- …with the Compound Development Team (CDTL) and project management, global regulatory affairs, clinical pharmacology, health economics, and the disease area leader ... evaluation and develops the strategy and the content for regulatory documents. + Works with senior clinical staff, establishes...- External** + An MD is required; Advanced degree ( PhD ) is a plus. + A minimum of 2… more
- Lilly (Philadelphia, PA)
- …and ensure retest and expirations dates can support clinical development and regulatory objectives & timelines + Maintain oversight of precursor and reference ... development, validation and stability reports and analytical sections in global regulatory dossiers and support responses to information requests from health… more
- Organon & Co. (Plymouth Meeting, PA)
- …objectives. + Collaborate with cross-functional teams, including clinical development, regulatory affairs, marketing and sales, to ensure alignment of medical ... medical expertise and strategic guidance to support product development, regulatory submissions, and commercialization efforts. + Support business development… more
- J&J Family of Companies (Malvern, PA)
- …for working with teams in the preparation of technical documents and regulatory submissions, participating in review, and contributing to development of strategies ... for all analytical topics including method development, control strategy and regulatory filings supporting FIH through commercial licensure. + Leading the… more
- PNC (Pittsburgh, PA)
- …programs to support the business(es) in managing risk while meeting business and regulatory expectations. + Oversees the timely and proper execution of the risk ... Communications, Industry Knowledge, Internal Controls, Operational Risk, Organizational Governance, Regulatory Environment - Financial Services **Work Experience** Roles at… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …for assigned areas. Knowledge and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay abreast of the latest ... and real-world evidence, US and global commercial teams, market access, and regulatory affairs, to ensure integrated global strategies and cohesive medical affairs… more