James Johnson
Certified Clinical Research Professional with experience in Regulatory, PMO/CRO, Transparency, and Promotional in Pharma/Biologics
- Role
- Regulatory Publisher Sr Assoc Consultant at Red Nucleus
- Location
- Wayne, PA, US
- LinkedIn followers
- 500 followers
About James Johnson
Experienced pharmaceutical professional with a varied background within the entire product lifecycle: grounded in clinical infrastructure, drug development programs, business partnering and product marketing initiatives. Demonstrated ability to operate independently with single accountability decision making, or to thrive while working on cross-functional teams, facilitating group consensus. Adept at coordinating with external and internal business partners to meet business objectives, and on-time deliverables, while managing repeatable processes, and computer systems, tracking, and improvements required for daily operations. Comfortable with Healthcare Professional (HCP) interactions. My direct drug development experience includes IND (Investigational New Drug) Phase I, II, IV and at all project stages (feasibility, start-up, maintenance, and closure including archiving). Therapeutic exposure includes dermatology and internal medicine, including cardiovascular, endocrine, respiratory, gastroenterology, infection, and inflammation.
Experience
Regulatory Publisher Sr Assoc Consultant
Jul 2023 — Present · US
Perform quality checking of regulatory documents and submissions to the FDA, while ensuring compliance with submission ready standards. Contributed to the supplemental Biologic license application (sBLA) for a new sponsor client in a large oncology program.
Education
Cedarville University
BA, Elementary Education
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