Job Title:
Senior Associate – Regulatory Writing
Job Information:
Job ID: R-224177
Location: India – Hyderabad
Work Type: On-site
Date Posted: August 29, 2025
Category: Regulatory
Company: Amgen
About Amgen:
Amgen is a global biotechnology pioneer, committed to using science and innovation to address some of the world’s most serious diseases. With over 40 years of leadership, Amgen remains on the cutting edge of medical breakthroughs, applying human genetic data and advanced technologies to develop therapies that transform patients' lives.
Position Summary:
The Senior Associate – Regulatory Writing will play a critical role in ensuring clinical trial transparency through the preparation and public disclosure of regulatory documents. This includes data anonymization, redaction of commercially confidential information (CCI), and submissions to global clinical trial registries such as ClinicalTrials.gov.
The role involves cross-functional collaboration, project management, regulatory compliance, and support for system and process improvement initiatives.
Key Responsibilities:
Document Preparation & Disclosure:
Prepare clinical regulatory documents for public disclosure, including:
Anonymization of personal data
Redaction of commercially confidential information
Content preparation for public registries (e.g., ClinicalTrials.gov)
Ensure consistency and quality across all documents
Maintain submission readiness and hand off for timely posting
Cross-Functional Collaboration:
Work closely with stakeholders to define redaction and disclosure strategies
Lead review and approval of documents in alignment with internal SOPs
Communicate and escalate issues when needed
Process & System Management:
Maintain written redaction strategies for studies and products
Support trend analysis and participate in process improvement
Ensure execution of the clinical trial disclosure process per:
Regulatory guidelines
Amgen’s policies
SOPs and disclosure standards
System Administration & Reporting:
Serve as Process Administrator for the Clinical Trial Registry System (CTRS):
Support user access and issue resolution
Generate and manage:
Reports
Trackers
Portals
Disclosure metrics
Audit Support:
Assist in preparation for and support of clinical trial disclosure audits and inspections
Ensure documentation is audit-ready
Required Skills & Competencies:
Strong ability to understand and interpret clinical data
Attention to detail, multi-tasking, and follow-through
Experience working in controlled regulatory environments
Excellent verbal and written English communication
Ability to influence and negotiate with stakeholders
Project management skills, including workload prioritization
Effective problem-solving and decision-making abilities
Basic Qualifications:
Bachelor’s degree
Minimum of 2 years of experience preparing regulatory documents for public disclosure
Solid understanding of:
Clinical research processes
Clinical regulatory documentation
Working knowledge of clinical trial disclosure regulations, guidelines, and industry best practices
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer, committed to a diverse and inclusive workforce. All qualified applicants will be considered without regard to:
Race, color, religion
Sex, sexual orientation, gender identity
National origin, veteran status, or disability
Amgen will provide reasonable accommodations for individuals with disabilities throughout the hiring process and employment.
Apply Now:
Click Here to Apply
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