Disclosure Analyst – Clinical Trial Data & Transparency
Jobs for Humanity · Pennsylvania
Job description
About the role
The Medical Writing & Disclosure department seeks an experienced professional to lead clinical trial data registration, results posting, redaction, and external data sharing, ensuring compliance with global regulations and company policies.
Key responsibilities
- Oversee clinical trial data registration, results postings, lay summary authoring, informed consent documents, and redaction operations.
- Manage a team of up to 60+ medical writers and specialists, including flex staff, to deliver all disclosure activities.
- Handle external requests for clinical data, review metrics, and drive process improvements.
- Serve as the primary contact for external transparency inquiries and collaborate with Legal, Communications, and Compliance.
Required profile
- 10+ years of biotech/pharmaceutical industry experience.
- Proven people‑management skills with ability to lead large, cross‑functional teams.
- Strong relationships with internal stakeholders such as OCMO, Legal, Compliance, GRA, and Communications.
- Experience working with oncology and vaccine confidence business areas.
Required skills
- Project management focused on quality and efficiency.
- Deep understanding of global regulations for clinical trial disclosure (FDAAA, EudraCT, etc.).
- Excellent written and oral communication, presentation, and public‑relations abilities.
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Published 2 weeks ago
Expires 1 month from now
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Jobs for Humanity
Pennsylvania
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