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Regulatory Writing Mgr

12+ years
Not Disclosed
10 Jan. 18, 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

Global Regulatory Writing Manager
Location: India - Hyderabad
Work Location Type: On Site
Date Posted: Jan. 10, 2025
Job ID: R-202309


About Amgen

Amgen is a pioneer in biotechnology, committed to discovering, developing, manufacturing, and delivering innovative medicines to combat the world’s toughest diseases. With over 40 years of excellence, Amgen leverages cutting-edge technology and human genetic data to improve lives.


Role Overview

As a Global Regulatory Writing Manager, you will be responsible for authoring and gaining approval for scientific and regulatory submission documents adhering to global standards. This role includes managing writing activities for product submissions, providing input to product teams, mentoring junior writers, and participating in departmental initiatives.


Roles & Responsibilities

  • Author regulatory documents such as Clinical Study Reports, Investigator Brochures, eCTD Module 2 Clinical Summaries, and other critical submission documents.
  • Review and approve authored documents in compliance with standard operating procedures.
  • Manage regulatory writing activities for product submissions, including NDAs and BLAs.
  • Serve as a functional area lead on cross-functional product teams.
  • Provide input for Global Regulatory Plans and team goals.
  • Mentor junior writers and collaborate with freelance writers.
  • Generate and maintain document timelines with input from relevant teams.
  • Stay updated on professional developments and relevant technologies.

Qualifications

Basic Qualifications:

  • Doctorate degree OR
  • Master’s degree with 3 years of related experience OR
  • Bachelor’s degree with 5 years of related experience OR
  • Associate’s degree with 10 years of related experience OR
  • High school diploma / GED with 12 years of related experience.

Preferred Qualifications:

  • Experience with regulatory documents in Regulatory Affairs, Research, or Development.
  • 5+ years of medical writing experience in the Biotech/Pharmaceutical industry.
  • Proficiency with Microsoft Office and advanced knowledge of scientific/technical writing.
  • Strong understanding of ICH and GCP guidelines.
  • Effective time management, leadership, and communication skills.
  • A self-motivated individual with excellent attention to detail.

Amgen’s Commitment

Amgen is an Equal Opportunity Employer. Accommodations are available for individuals with disabilities during the application or interview process and for essential job functions.