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Regulatory Writing Senior Manager

14-18 years
Not Disclosed
10 Dec. 3, 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

Job Title: Senior Medical Writer – Regulatory Submissions
Location: Flexible (Remote/On-Site Opportunities)
Employment Type: Full-Time


About Amgen

At Amgen, we’re inspired by our mission to serve patients and driven by innovation. For more than 40 years, we’ve been a leader in biotechnology, leveraging cutting-edge science and genetic data to develop life-changing medicines. Join a collaborative, science-focused culture where your contributions help shape the future of healthcare.


What You Will Do

Let’s do this. Let’s change the world.

As a Senior Medical Writer, you’ll be responsible for preparing and managing regulatory submission documents that meet global regulatory standards. You’ll play a vital role in ensuring the quality and timely delivery of documents for products across all phases of development, while mentoring team members and contributing to organizational initiatives.

Key Responsibilities:

  • Document Preparation & Oversight:
    Prepare and oversee the preparation of regulatory submission documents, including:

    • Clinical study reports (CSRs) and Investigator Brochures
    • CTD sections: Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overviews, etc.
    • Briefing documents, white papers, breakthrough therapy applications, orphan drug applications
  • Project Management:

    • Manage study timelines for regulatory documents
    • Oversee regulatory submission strategy and ensure adherence to project plans
  • Leadership & Mentorship:

    • Act as a functional lead on product teams
    • Train, mentor, and manage medical writers
    • Assist in hiring, resource allocation, and departmental governance
  • Quality Assurance:

    • Ensure the quality and consistency of submission documents across all stages of development
    • Provide expertise and guidance on document design and best practices
  • Collaboration & Initiative:

    • Participate in departmental and cross-departmental initiatives
    • Contribute to meetings and strategic discussions

What We Expect of You

We value diverse perspectives and skills. For this role, we’re seeking an experienced professional with the following 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 in writing regulatory or scientific submission documents OR
  • Bachelor’s degree with 10-14 years of experience in writing regulatory or scientific submission documents OR
  • Diploma with 14-18 years of experience in writing regulatory or scientific submission documents

Preferred Qualifications:

  • Degree in biology, chemistry, or a related scientific discipline (BS, MS, or higher)
  • Advanced knowledge of regulatory guidelines (e.g., ICH) and compliance standards
  • Strong expertise in writing clinical and regulatory documents
  • Proven ability to analyze medical data and interpret its significance
  • Excellent written and verbal communication skills with attention to detail
  • Proficiency in time and project management, with strong leadership and negotiation skills
  • Experience managing and mentoring team members
  • A collaborative mindset with the ability to navigate complex team dynamics

What You Can Expect of Us

At Amgen, we prioritize your personal and professional growth. From competitive benefits to a supportive, inclusive culture, we’re here to help you thrive.

Benefits Include:

  • Comprehensive health, dental, and vision plans
  • Generous retirement and savings plans with company contributions
  • Paid time off, including company-wide shutdowns
  • Career development programs and mentorship opportunities
  • Flexible work models to support work-life balance

Apply Now

For a career that defies imagination, join us at Amgen. Together, we’ll transform lives—including your own.

Visit careers.amgen.com to apply.


Amgen is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Reasonable accommodations are available for individuals with disabilities throughout the hiring process.