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Global Regulatory Writing Manager

10-12 years
Not Disclosed
10 Dec. 3, 2024
Job Description
Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD 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: Regulatory Medical Writer


About the Job

Amgen is at the forefront of biotechnology, driving innovation for over 40 years. In this pivotal role as a Regulatory Medical Writer, you will discover, develop, manufacture, and deliver cutting-edge medicines to help millions of patients. Your work will help shape the regulatory landscape of life-changing therapies through the preparation of key submission documents that comply with global standards.


Main Responsibilities

  • Document Preparation & Authoring

    • Author regulatory submission documents, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Informed Consent Forms, Clinical Overview Addenda, Pediatric Investigation Plans, and eCTD Module 2 Clinical Summary Documents.
    • Review and ensure approval of authored documents following standard operating procedures.
  • Regulatory Submission & Strategy

    • Manage regulatory writing activities for new drug applications (NDAs) and supplemental drug applications (sNDAs) or biologics license applications (BLAs), with considerable supervision.
    • Serve as a functional area lead on product teams such as Global Regulatory Teams and Safety Teams.
  • Collaboration & Mentorship

    • Foster key business relationships with cross-functional product team members.
    • Assist in the training and mentoring of more junior writers.
    • Participate in departmental and cross-departmental initiatives.
  • Document & Project Management

    • Generate document timelines with team input and ensure all deliverables are met on time.
    • Stay informed on relevant professional information and technological advancements.

What We Expect of You

We seek a motivated, results-oriented individual who can drive the preparation of high-quality regulatory documents while collaborating effectively with cross-functional teams. If you have a passion for scientific writing, project management, and regulatory processes, you will thrive in this role.


Qualifications

Basic Qualifications:

  • Doctorate degree, or
  • Master’s degree + 4-6 years of directly related experience, or
  • Bachelor’s degree + 6-8 years of directly related experience, or
  • Diploma + 10-12 years of directly related experience.

Preferred Qualifications:

  • Proficiency with Microsoft Office Programs and other word processing tools.
  • Significant experience in scientific/technical writing and editing.
  • In-depth knowledge of the clinical development process for new compounds.
  • Understanding and application of ICH and Good Clinical Practice (GCP) guidance.
  • Knowledge of relevant SOPs, guidance documents, and work instructions.

Soft Skills:

  • Excellent written and oral communication skills with a keen eye for detail.
  • Strong leadership abilities in a collaborative team environment.
  • Time and project management skills, with the ability to negotiate and collaborate across departments.
  • Self-starter with a strong drive to achieve results.

What You Can Expect from Us

At Amgen, your professional and personal growth is our priority. Alongside a competitive salary, you’ll benefit from comprehensive Total Rewards Plans and a supportive, collaborative work culture. We are committed to fostering an environment where you can thrive, grow, and make a real difference.


Ready to take the next step? Apply now for a career that defies imagination.

Visit us at careers.amgen.com.