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Associate, Regulatory Writing

1-2 years
Not Disclosed
10 May 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

Location: India – Hyderabad (On Site)
Job ID: R-210834
Date Posted: April 3, 2025
Category: Regulatory


Job Summary

The Associate, Regulatory Writing will assist in preparing, formatting, and reviewing regulatory and clinical documents to ensure compliance with Amgen’s submission standards. This role supports document readiness for regulatory submissions by maintaining quality, consistency, and professional formatting, while working closely with cross-functional teams.


Key Responsibilities

  • Perform quality control (QC) checks on regulatory documents (e.g., layout, data consistency, referencing, formatting)

  • Ensure formatting aligns with Amgen’s submission readiness guidelines

  • Coordinate document collection and ensure documents are publishing-ready

  • Support noncomplex document development (e.g., Clinical Study Reports, Protocols, Risk Management Plans)

  • Participate in cross-functional reviews and timeline tracking

  • Attend meetings with writers and team members to support document progress

  • Maintain reference libraries across therapeutic areas

  • Use Amgen’s document tools and adhere to SOPs and style guides


Documents in Scope Include

  • Clinical Study Reports (CSRs)

  • Observational Research Study Reports

  • Investigator’s Brochures

  • Local Risk Management Plans

  • Informed Consent Forms (ICFs)

  • Protocols and Amendments

  • Plain Language Summaries


Basic Qualifications

  • Bachelor’s degree in Science from an accredited institution


Preferred Qualifications

  • 1–2 years of experience in document formatting, QC, and coordination in pharma/biotech

  • Exposure to scientific and medical content

  • Familiarity with statistical and medical communication principles

  • Proficient in Microsoft Office, SharePoint, and document management systems

  • Excellent attention to detail, communication skills, and problem-solving ability

  • Able to multi-task, manage deadlines, and work independently and within teams