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Senior Associate – Regulatory Writing

2+ years
Not Disclosed
10 Sept. 2, 2025
Job Description
Job Type: Full Time Education: Bachelor’s degree Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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:

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