- CSL Behring (King Of Prussia, PA)
- …accelerate innovation and create greater impact for patients. With a streamlined, project -led structure and a focus on collaboration, we're building a future-ready ... meaningful difference worldwide. Could you be our next Senior Manager US Advertising and Promotion Lead? The job is...programming based on US Code of Federal Regulations and FDA implementing regulations and guidance. + Adhere to related… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and… more
- Wolters Kluwer (Philadelphia, PA)
- The **Principal SaMD Technical Program Manager ** plays a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This ... ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. They...dependencies. They provide oversight to various aspects of the project portfolio, coordinating meetings and project deliverable… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable for driving timely and high-quality data management deliverables ... supporting the Olympus portfolio. The Sr. Clinical Data Manager designs, develops, and maintains key data management deliverables used to collect, review, monitor,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- UPMC (Pittsburgh, PA)
- University of Pittsburgh Physicians is hiring a full-time Research Manager to assist the Hepatobiliary Surgery team. This position is located at the Kaufmann ... of their specific projects. + Routinely monitors all trials for compliance with FDA , UPMC and IRB compliance; promptly and effectively reports any issues to… more
- CSL Behring (King Of Prussia, PA)
- …is accelerating innovation to deliver greater impact for patients. With a project -led structure and a focus on collaboration, we're building a future-ready team ... GRA. With support, engaging with health authority (HA) in stationed country ( FDA or EMA), maintaining productive relationship with HA contacts and driving positive… more
- West Pharmaceutical Services (Williamsport, PA)
- Senior Quality Manager Requisition ID: 71560 Date: Nov 26, 2025 Location: Williamsport, PA, US Department: Quality Description: **_This is an onsite position ... Representative + Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner. + In accordance with US...processes preferred. + 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical… more
- Globus Medical, Inc. (Audubon, PA)
- …product literature, brochures, and all sales support information . Assists Group Manager and Project Engineer with creating sales, surgeon, and management ... their lives as quickly as possible. **Position Summary** **:** The Product Manager is responsible for supporting the Biologics Product Development team, designing,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Job Summary** The Manager , Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across ... quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA /ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and… more