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Clinical Trials Disclosure Manager

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Amgen

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Location:
India , Hyderabad

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Category:
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Contract Type:
Not provided

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Salary:

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Job Responsibility:

  • Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidance, and company requirements
  • Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting
  • Support trend analysis and continuous improvement initiatives
  • Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines

Requirements:

  • Graduate degree and 2 years of relevant work experience in the pharmaceutical industry
  • Bachelor’s degree, and 4 years relevant work experience in the pharmaceutical industry
  • Minimum of 2 years experience in preparation of regulatory documents for public disclosure
  • Familiarity with international regulations, guidance and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information
  • Experience understanding and interpreting data/information and its practical application
  • Working experience with redaction/anonymization of clinical trial documents e.g. for EU CTR, HC-PRCI
  • Working experience with disclosures on public registries e.g. ClinicalTrials.gov
  • Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
  • Good communication skills including excellent spoken and written English
  • Ability to follow controlled processes
  • Leadership skills, including ability to teach, negotiate and influence
  • Project management skills, including ability to prioritize work in order to meet required deadlines
  • Problem solving ability
  • Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution

Additional Information:

Job Posted:
February 13, 2026

Work Type:
On-site work
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