- Organon & Co. (Plymouth Meeting, PA)
- …strategy. Additionally, cross-functional interactions with early clinical development, late- clinical development, regulatory affairs , safety and ... regulators, scientific leaders, and physicians, as needed. + Oversight and/or review non- clinical CTD modules, briefing books, or other regulatory communications… more
- Organon & Co. (Plymouth Meeting, PA)
- …work collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing ... Investigator Brochures, briefing books, IND subsections, submission modules and other regulatory documents. + Provide clinical pharmacology subject matter… more
- Pfizer (Collegeville, PA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational ... Experience working with and solid understanding of related disciplines, eg, Clinical Operations, Data Management, Safety, Biostatistics, Regulatory , Study… more
- CSL Behring (King Of Prussia, PA)
- Associate Director, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Associate Director, Corporate and External Affairs , R&D Portfolio will ... candidate will be responsible for driving communications for key pipeline milestones and clinical trials. They will serve as a strategic partner on R&D policy. They… more
- CSL Behring (King Of Prussia, PA)
- The Director, Medical Affairs Statistics will support product marketing by generation of scientifically valid evidence that goes beyond the product label. The ... and strategic partnering with key stakeholders for life-cycle-management (LCM) clinical trials initiated by the commercial organization; evaluate alternatives to… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Clinical Trial Coordinator (Sr. CTC) will be responsible for supporting ... the clinical project team during all stages of a ...and collection of study-specific documents required in the site's Regulatory Binder. + Assist in tracking study activies and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …areas. + Execute global internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates audit corrective actions ... and compliance for the design, manufacture, and service of clinical and research products. Primary Responsibilities: The Global Vice...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Organon & Co. (Plymouth Meeting, PA)
- …experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least three ... management. + Worked on programs in one or more phases of development (discovery, non- clinical , Phase 1, 2, 3, launch). + Worked effectively in a team setting as… more
- CSL Behring (King Of Prussia, PA)
- …Medical and Tender use cases) In close partnership with ABCIA Commercial, Medical Affairs , and Market Access teams to ensure solutions are aligned with strategic ... record of developing and deploying machine learning models in commercial or clinical contexts. Strong analytical and problem-solving skills, with the ability to… more
- PCI Pharma Services (Philadelphia, PA)
- …across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives ... properly followed and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions… more
