Amgen UK is seeking a Clinical Trials Disclosure Manager to lead the preparation of clinical regulatory documents for public disclosure, ensuring compliance with applicable regulations and guidelines. The ideal candidate will have experience in data anonymization, project management, and regulatory document preparation within the pharmaceutical industry
Job Summary
The role involves leading the preparation of clinical regulatory documents for public disclosure while ensuring strict adherence to anonymization and redaction standards.
Candidates will collaborate with transparency teams and cross-functional stakeholders to define redaction strategies for US and EU registries like ClinicalTrials.gov.
Amgen seeks a self-motivated professional capable of managing projects, prioritizing work, and solving problems to meet critical internal and external deadlines.
Matching Summary
Match Score: 85
Amgen UK is seeking a Clinical Trials Disclosure Manager to lead the preparation of clinical regulatory documents for public disclosure, ensuring compliance with applicable regulations and guidelines. The ideal candidate will have experience in data anonymization, project management, and regulatory document preparation within the pharmaceutical industry.
Skills & Requirements
Must-have
Redaction of clinical trial documents
EU CTR and HC-PRCI compliance
Public registry disclosure experience
Anonymization of personal data
Cross-functional project coordination
Nice-to-have
Trend analysis and continuous improvement
Strong leadership and negotiation skills
Process administration for CTRS system
Excellent written and spoken English
Key Requirements
Graduate degree plus 2 years pharmaceutical experience OR Bachelor's plus 4 years
Minimum 2 years in regulatory document preparation for public disclosure
Familiarity with international clinical transparency regulations and guidance