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Regulatory Writing Senior Manager

14-18 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: BS/MS 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

This opportunity at Amgen for a Regulatory Medical Writer or equivalent role emphasizes leadership in developing high-quality regulatory submission documents and guiding teams through complex medical writing processes for clinical and regulatory submissions. The position offers a chance to directly impact global regulatory success while mentoring and managing a team of medical writers.


Roles & Responsibilities

Document Preparation and Oversight

  • Author or oversee the creation of high-quality regulatory submission documents adhering to global standards.
  • Prepare clinical study reports and Investigator Brochures for all clinical development phases (1–4).
  • Write Common Technical Document (CTD) sections such as:
    • Summary of Clinical Efficacy
    • Summary of Clinical Safety
    • Summary of Clinical Pharmacology
    • Summary of Biopharmaceutics
    • Clinical Overview
    • Table of All Studies
    • Safety narratives and briefing documents
  • Develop additional regulatory submissions, including RTQs, PIPs, white papers, and orphan drug or breakthrough therapy applications.

Project and Team Management

  • Manage study timelines for regulatory submissions and contribute to regulatory submission strategy.
  • Act as a functional lead on product teams, representing the medical writing function.
  • Supervise, train, and mentor medical writers while managing the work of the Global Regulatory Writing (GRW) team.
  • Assist in hiring, resource allocation, and departmental governance.

Quality Assurance and Expertise

  • Ensure document quality across all development stages.
  • Provide strategic guidance on document design and medical writing best practices to teams.
  • Contribute to departmental meetings and initiatives to foster innovation and collaboration.

Qualifications

Basic Qualifications

  • Doctorate degree with 2+ years of experience in writing regulatory or scientific submission documents; OR
  • Master’s degree with 8–10 years of experience; OR
  • Bachelor’s degree with 10–14 years of experience; OR
  • Diploma with 14–18 years of experience.

Preferred Qualifications

  • Advanced degree in biology, chemistry, or a related scientific discipline.
  • Proven experience in clinical and regulatory writing.
  • Deep understanding of ICH guidelines and other regulatory standards.
  • Strong analytical skills for interpreting medical data.
  • Advanced communication and attention to detail.
  • Leadership experience, including mentoring and team development.
  • Proficiency in project and time management, negotiation, and collaboration.
  • Expertise in supervising teams and leading in cross-functional environments.

What Amgen Offers

Amgen supports career growth and well-being through competitive benefits, a collaborative culture, and comprehensive Total Rewards Plans aligned with industry standards.


How to Apply

For those ready to lead and shape the future of regulatory submissions, apply now at careers.amgen.com.

Join Amgen, where your work changes lives.