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Regulatory Writing Mgr

10-12 years
Not Disclosed
10 Dec. 5, 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

This role at Amgen combines scientific excellence, collaborative teamwork, and the opportunity to contribute meaningfully to the development of treatments that serve patients globally. As a Medical Writer, you'll play a vital role in the preparation and oversight of key regulatory documents, while collaborating across functional teams and mentoring peers.


Join Amgen’s Mission of Serving Patients

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've been at the forefront of biotechnology, innovating treatments across Oncology, Inflammation, General Medicine, and Rare Disease.

With a collaborative, innovative, and science-based culture, Amgen is the place for those passionate about challenges and opportunities. Here, you can make a lasting impact on patients’ lives while transforming your career.


What You Will Do

Let’s change the world. In this vital role, you will author and gain approval for scientific and regulatory documents that meet global regulatory standards. You'll manage writing activities for submissions, collaborate with cross-functional teams, and mentor junior writers—all while contributing to departmental and cross-departmental initiatives.

Key Responsibilities

  • Author Key Regulatory Documents:
    Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, eCTD Module 2 summaries, Informed Consent Forms, Pediatric Investigation Plans, and more.
  • Document Management:
    Conduct reviews and approvals, ensuring adherence to SOPs and regulatory standards.
  • Project Oversight:
    Manage timelines, milestones, and team input for submission documents.
  • Cross-Functional Collaboration:
    Serve as the functional lead on product teams, providing regulatory input and contributing to strategic goals.
  • Mentorship and Development:
    Train junior writers and collaborate with contractors or freelance writers.
  • Continuous Learning:
    Stay updated on professional advancements and technological tools to enhance the quality and efficiency of deliverables.

What We Expect of You

We embrace diverse backgrounds, recognizing that unique contributions drive our shared success.

Basic Qualifications

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

Preferred Qualifications

Functional Skills

  • Proficiency with Microsoft Office and regulatory tools.
  • Extensive knowledge of ICH and Good Clinical Practice (GCP) guidelines.
  • Strong understanding of the clinical development lifecycle.

Soft Skills

  • Exceptional communication and attention to detail.
  • Leadership and team collaboration skills.
  • Excellent time management and organizational abilities.
  • A self-starter attitude with a drive to achieve results.

What You Can Expect of Us

At Amgen, we care deeply about your professional and personal growth. Alongside our commitment to innovation, we support you with:

  • Competitive and comprehensive Total Rewards Plans aligned with industry standards.
  • A collaborative and inclusive culture that values your contributions.
  • Continuous learning and career development opportunities.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and ensures that individuals with disabilities are provided reasonable accommodations for the job application process, interviews, essential job functions, and access to benefits.


Apply Now
Ready to transform lives—yours and others’? Join us at careers.amgen.com.

Objects in your future are closer than they appear.
Join Amgen.