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Regulatory Writing Sr Mgr

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 Regulatory Medical Writer


About the Job

At Amgen, we are committed to developing treatments that improve lives. In this vital role, you will prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards. You will lead efforts to write and review clinical and regulatory documents, ensuring high-quality deliverables throughout the clinical development process.


Main Responsibilities

  • Document Preparation & Oversight

    • Write and oversee the preparation of key regulatory documents, including:
      • Clinical Study Reports
      • Investigator Brochures
      • CTD Sections (e.g., Clinical Overview, Clinical Efficacy, Safety, Pharmacology, Biopharmaceutics)
      • Regulatory Submission Documents (e.g., RTQs, PIP, breakthrough therapy applications, orphan drug applications)
    • Manage the writing process for high-stakes regulatory documents in all phases of clinical development (Phase 1-4).
  • Team Leadership & Management

    • Manage, mentor, and train medical writers within the team.
    • Oversee the work of GRW staff, ensuring adherence to quality and timelines.
    • Assist with hiring, resourcing, and departmental governance activities.
    • Lead and represent functional areas on product teams, ensuring regulatory document quality at all stages of development.
  • Strategic Oversight

    • Develop and manage study timelines for regulatory documents and submissions.
    • Provide strategic direction on the regulatory submission strategy and timelines.
    • Collaborate with cross-departmental teams, participating in departmental and organizational initiatives.
  • Expert Guidance

    • Provide expert advice on document design, principles of medical writing, and regulatory compliance to both internal teams and product teams.
    • Ensure that all documents adhere to regulatory guidance and industry compliance standards.

What We Expect of You

We seek a dynamic and skilled professional who is detail-oriented, capable of leading teams, and adept at navigating complex regulatory landscapes. The ideal candidate will bring a blend of strong technical writing expertise and the ability to effectively manage teams and stakeholders.


Qualifications

Basic Qualifications:

  • Doctorate Degree + 2 years of regulatory or scientific writing experience, or
  • Master’s Degree + 8-10 years of regulatory or scientific writing experience, or
  • Bachelor’s Degree + 10-14 years of regulatory or scientific writing experience, or
  • Diploma + 14-18 years of regulatory or scientific writing experience.

Preferred Qualifications:

  • BS, MS, or higher degree in Biology, Chemistry, or other scientific disciplines.
  • Extensive experience in writing clinical and regulatory documents.
  • Expertise in scientific/technical writing, editing, and related regulatory guidance (e.g., ICH).
  • Strong leadership and team management skills.
  • Proficient in time/project management, negotiation, and collaboration.
  • Ability to interpret medical data and analyze its significance.
  • Advanced written and verbal communication skills with exceptional attention to detail.
  • Proven ability to mentor and train junior team members.

What You Can Expect from Us

At Amgen, we care for the professional and personal growth of our employees. Alongside competitive total rewards plans aligned with industry standards, we offer a collaborative culture and professional support every step of the way.


Ready to make a meaningful difference? Apply now for a career that defies imagination.

Visit us at careers.amgen.com.