- ThermoFisher Scientific (Allentown, PA)
- …Pharmacy or equivalent. 15+ years of cGMP experience in a global pharmaceutical industry. Experience with regulatory authorities from an auditing perspective ... with regulatory experience in a pharmaceutical GMP environment highly preferred. Experience with remediation, eg warning letters and consent decrees and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …Operations oversees the execution of field fleet logistics and pharmaceutical sample distribution. The role ensures vendor performance, operational reliability, ... and compliance while collaborating closely with the Field Strategy & Operations team to meet field force needs....not limited to oversight of distribution and inventory of pharmaceutical samples to field representatives. + Proactively engage with… more
- Lilly (Philadelphia, PA)
- …communication with senior management and across relevant functional areas. + Support regulatory strategy development and health authority interactions related to ... decision-making and host formal staged readiness reviews wherever applicable. + Support regulatory strategy development and health authority interactions as the… more
- Guidehouse (Philadelphia, PA)
- …Market Access team focuses on value, access, pricing and commercialization strategy projects for pharmaceutical , biotechnology, medical device, and diagnostics ... roles + Experience developing designing and executing value, pricing, and access strategy projects for pharmaceutical , biotech and medical device companies +… more
- Sumitomo Pharma (Harrisburg, PA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... . The Director, Patient & HUB Operations, Rare Disease will lead the strategy , development, and operation of the RETHYMIC CONNECT(R) patient support program & HUB… more
- Sumitomo Pharma (Harrisburg, PA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre-clinical research, Medical Affairs and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... and assist in the development and delivery of the overall Global Quality (GQ) strategy . + This position is responsible for ensuring internal and external sites are… more
- Prime Therapeutics (Harrisburg, PA)
- …Pharmacy Trade Relations - Remote **Job Description** The Sr Director, Pharmaceutical Trade Relations is responsible for managing Prime's Trade Relations program(s) ... and market access strategies and all related partner/customer relationships including pharmaceutical manufacturers, with specific emphasis on Medicare Part D and… more
- J&J Family of Companies (Horsham, PA)
- …Education, Operations, Brand Marketing and/or Sales Management). + Knowledge of pharmaceutical marketing including FDA regulatory and legal environment and ... of the way. Learn more at https://www.jnj.com/innovative-medicine This position within the Strategy & Operations team is part of the commercial organization at… more
- Merck (West Point, PA)
- …process demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP CMC sections of ... commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. It is the division's leader in sterile...filing. Reviews regulatory strategy and filing readiness and supports… more