Job Title:
Clinical Trials Disclosure Manager
Job Information:
Job ID: R-224180
Location: India – Hyderabad
Work Type: On-site
Date Posted: August 29, 2025
Category: Regulatory
Company: Amgen
About Amgen:
Amgen is a global leader in biotechnology, using cutting-edge science, human genetic data, and advanced technologies to fight the world’s toughest diseases. With a history spanning over 40 years, Amgen continues to discover, develop, manufacture, and deliver innovative medicines that improve the lives of millions of patients around the world.
Position Summary:
As a Clinical Trials Disclosure Manager, you will be responsible for overseeing the preparation and public disclosure of clinical regulatory documents, ensuring compliance with global transparency regulations. This includes data anonymization, redaction of commercially confidential information (CCI), and management of clinical trial disclosures across various public registries such as ClinicalTrials.gov and EU CTR.
You will lead cross-functional collaboration, manage timelines, and support continuous improvement in the trial disclosure process.
Key Responsibilities:
Document Preparation & Public Disclosure:
Lead the preparation and redaction/anonymization of clinical regulatory documents for public disclosure.
Ensure alignment with international regulations, company policies, and best practices.
Work closely with cross-functional teams to define and implement redaction strategies.
Regulatory Compliance & Submissions:
Manage the registration and results posting processes for:
US and EU clinical trial registries (e.g., ClinicalTrials.gov, EU CTR)
Ensure documents are reviewed, approved, and submission-ready.
Oversee the handoff for timely posting or submission to public databases.
Process Ownership & Project Management:
Serve as the Process Administrator for the Clinical Trial Registry System (CTRS):
Support active users, system access, issue resolution, and inquiries.
Lead project planning and coordination, ensuring internal and external deadlines are met.
Support trend analysis and contribute to continuous improvement initiatives.
Required Skills & Competencies:
Demonstrated ability to interpret complex data and apply it effectively.
Hands-on experience in:
Redaction/anonymization of clinical documents (e.g., EU CTR, HC PRCI)
Disclosure processes on public registries (e.g., ClinicalTrials.gov)
Strong project management and leadership skills.
Excellent communication skills, both verbal and written.
Self-motivated with proven multi-tasking, attention to detail, and problem-solving capabilities.
Ability to follow controlled processes and ensure document quality and compliance.
Capable of teaching, influencing, and negotiating within cross-functional teams.
Basic Qualifications (any one of the following):
Graduate degree with a minimum of 2 years of relevant experience in the pharmaceutical industry, OR
Bachelor’s degree with a minimum of 4 years of relevant pharmaceutical industry experience
Additional Required Experience:
At least 2 years of experience in preparing regulatory documents for public disclosure
Familiarity with international clinical transparency regulations and guidance:
Redaction of personal information and commercially confidential information
Global registry requirements and best practices
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer, committed to building a diverse and inclusive environment. All qualified applicants will receive consideration without regard to:
Race, color, religion, sex
Sexual orientation or gender identity
National origin, veteran status, or disability
Amgen provides reasonable accommodations for individuals with disabilities during the application and interview process, as well as for performing essential job functions.
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