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Associate Regulatory Writing

1 year 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:

Associate Regulatory Writing


Job Details:

  • Job ID: R-224167

  • Location: India – Hyderabad

  • Work Type: On-site

  • Date Posted: August 29, 2025

  • Category: Regulatory

  • Company: Amgen


About Amgen:

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and improve patients’ lives. With over 40 years of biotechnology innovation, Amgen continues to lead with cutting-edge science and human genetic data to develop and deliver life-changing medicines globally.


Roles & Responsibilities:

  • Prepare clinical regulatory documents for public disclosure, including:

    • Anonymization of personal data

    • Redaction of commercially confidential information

  • Ensure consistent quality across documents, maintain submission readiness, and ensure timely submission or posting

  • Collaborate with team members to resolve problems and escalate issues as needed

  • Record and maintain written redaction strategies for studies and products

  • Manage timelines and coordinate work across the team

  • Execute clinical trial disclosure processes ensuring compliance with:

    • Regulatory requirements

    • Amgen policies

    • SOPs and guidance documents

  • Act as tactical point of contact for assigned responsibilities, complete assigned action items, and maintain documentation

  • Assist and support clinical trial disclosure audits and inspections

  • Serve as Process Administrator for the Clinical Trial Registry System (CTRS):

    • Support active users, manage system access, handle inquiries, and resolve issues

  • Generate and manage reports, trackers, portals, and metrics activities


Required Skills:

  • Ability to understand and interpret data/information and apply it practically

  • Self-motivated with strong multitasking, attention to detail, and follow-through

  • Ability to follow controlled processes

  • Excellent spoken and written English communication skills

  • Project management skills, including the ability to prioritize work to meet deadlines

  • Strong problem-solving ability


Basic Qualifications:

  • Bachelor’s degree

  • Minimum 1 year experience working with regulatory documents in a biotech/pharmaceutical environment

  • Familiarity with clinical research and clinical regulatory documents

  • Knowledge of clinical trial disclosure regulations, guidelines, and best practices


Preferred Qualifications:

  • Over 1 year experience preparing regulatory documents for public disclosure

  • Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), ClinicalTrials.gov, EudraCT, EU CTIS, and other registries

  • Experience with redaction/anonymization of clinical trial documents


Equal Opportunity Statement:

Amgen is an Equal Opportunity Employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Reasonable accommodations are provided to individuals with disabilities throughout the hiring process and employment. Please contact Amgen to request accommodations.


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