- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals… more
- ThermoFisher Scientific (Allentown, PA)
- …communities depend on - now and in the future. ROLE: Regulatory Intelligence Manager LOCATION: Fully Remote, East Coast is highly preferred **Position Summary** The ... Regulatory Intelligence Manager will play a pivotal role in monitoring, analyzing,...changes, guidance documents, and policy trends across key markets ( FDA , EMA, PMDA, etc.) or stakeholders (EU Commission, ICH,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** Manager , Quality Assurance External Manufacturing is responsible for managing ... and the suppliers. + Ensure regulatory and contractual compliance in accordance to FDA , ISO 13485, ISO 9001, MDSAP, EUMDR, and applicable regulations. + Develops… more
- Edwards Lifesciences (Pittsburgh, PA)
- …journey. The primary objective of **the Outreach and Physician Education Program Manager ** is to execute Transcatheter Heart Valve's (THV's) vision to ensure the ... that are in need and meet the requirements for treatment. The **OPE Manager ** will support the Provider Engagement and Strategic Sales Programs Team, with an… more
- Sumitomo Pharma (Harrisburg, PA)
- …Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and ... project teams, as required. + Coordinate responses to ad...and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for… more
- Pfizer (Collegeville, PA)
- …the Clinical Development &Operations (CD&O) organization, the Senior Associate, eCOA Manager , Clinical Data Collection Strategies is responsible for assisting in the ... + Experience in eCOA study design + Demonstrated experience of project , vendor management + Practical experience interfacing and achieving concordance with… more
- Edwards Lifesciences (Harrisburg, PA)
- …lives. Join us and be part of our inspiring journey. The Senior Manager , Medical Writing oversees medical writing projects and team operations in compliance with ... Edwards criteria + Certification in related fields + Strong leadership in project and team management, including coaching and performance oversight. + Expertise in… more
- Dairy Farmers of America (New Wilmington, PA)
- …personnel (eg, electrical engineers, technicians, contractors) and funding to ensure the project or mission fulfills and meets the set objectives defined within the ... network communication, distribution switches * Knowledge of Federal Drug Administration ( FDA ), GMP, Occupational Safety and Health Administration (OSHA), and US… more
- Globus Medical, Inc. (Audubon, PA)
- …several stages of development (ie existing portfolio, near-term launch, pending FDA approval and new products). Supports product lifecycle management, product ... customers, vendors, peers, and leadership + Ability to lead cross-functional project teams + Proficient in procedures, clinical applications, and products; engages… more
- BD (Becton, Dickinson and Company) (Zelienople, PA)
- **Job Description Summary** Under the supervision of the Manufacturing Engineering Manager , the Manufacturing Engineer is responsible for supporting manufacturing by ... on projects and will plan, schedule, organize, and drive completion of project activities. The Manufacturing Engineer is responsible for supporting manufacturing by… more