Job Title: Writing
Location: Hyderabad, India (On-Site)
Job ID: R-224177
Date Posted: August 29, 2025
Category: Regulatory
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and improve people’s lives. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients. A pioneer in biotechnology for over 40 years, Amgen continues to push the boundaries of science using cutting-edge technology and human genetic data.
Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information.
Prepare documents for public registries (e.g., ClinicalTrials.gov).
Collaborate with cross-functional stakeholders to define redaction strategies, ensure review and approval, and prepare documents for timely submission or posting.
Maintain consistent quality across documents and ensure submission readiness.
Communicate with team members and stakeholders to resolve issues and escalate as needed.
Document and maintain written redaction strategies for studies and products.
Support trend analysis and continuous process improvement.
Execute clinical trial disclosure business processes in compliance with regulations, Amgen policies, SOPs, and guidance documents.
Serve as a tactical point of contact for assigned responsibilities and maintain documentation.
Assist with trial disclosure audits and inspections.
Act as Process Administrator for CTRS, supporting active users, system access, inquiries, and issue resolution.
Generate and manage reports, trackers, portals, and metrics.
Strong ability to understand and interpret data and apply it practically.
Self-motivated with excellent multitasking, attention to detail, and follow-through.
Ability to follow controlled processes and maintain compliance.
Excellent written and spoken English communication skills.
Strong stakeholder communication and negotiation skills.
Project management skills, including prioritizing work to meet deadlines.
Strong problem-solving ability.
Bachelor’s degree.
Minimum 2 years of experience preparing regulatory documents for public disclosure.
Understanding of clinical research and clinical regulatory documents.
Working knowledge of clinical trial disclosure regulations, guidelines, and best practices.
Amgen is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Reasonable accommodations are available for individuals with disabilities to participate in the job application or interview process, perform essential job functions, and access other employment benefits. Contact Amgen to request accommodation.
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