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    Regulatory Writing Senior Manager

    Amgen
    14-18 years
    Not Disclosed
    Hyderabad
    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 innovative treatments that improve lives. As a Senior Regulatory Medical Writer, you will play a crucial role in preparing and overseeing the creation of high-quality regulatory submission documents that comply with global regulatory standards. This includes writing and managing critical documents across all phases of clinical development, ensuring that Amgen continues to lead in the pharmaceutical industry.

    Main Responsibilities

    • Document Preparation & Oversight

      • Write or oversee the writing of clinical study reports, investigator brochures, and other essential regulatory documents (e.g., RTQs, PIP, breakthrough therapy applications, orphan drug applications).
      • Prepare CTD sections such as the Summary of Clinical Efficacy, Safety, Pharmacology, Biopharmaceutics, Clinical Overview, and Study Tables.
      • Manage the preparation of regulatory submissions for products in all clinical phases (Phase 1-4), including safety narratives and briefing documents.

    • Project and Team Leadership

      • Lead product teams and act as a functional area representative for regulatory submissions.
      • Manage, mentor, and train medical writers and GRW staff, ensuring their alignment with regulatory writing standards.
      • Oversee timelines and strategies for regulatory documents, ensuring they are delivered on time and meet the highest quality standards.

    • Quality Control & Expert Guidance

      • Ensure regulatory documents maintain high quality throughout all stages of development.
      • Provide guidance on document design, principles of medical writing, and ensure adherence to regulatory guidance (e.g., ICH).
      • Offer expertise to product teams and the department, ensuring documents meet regulatory requirements for submission.

    • Collaboration and Mentorship

      • Work closely with various departments to ensure regulatory submissions are aligned with company goals.
      • Support departmental initiatives and actively participate in cross-departmental projects.
      • Mentor junior writers and assist in hiring and resourcing therapeutic areas and project teams.

    What We Expect of You

    We are looking for a dynamic, results-driven professional who is passionate about contributing to the development of life-changing treatments. The ideal candidate will possess a blend of strong leadership and expert technical writing skills. You should be comfortable operating in a collaborative environment and be capable of managing multiple projects while maintaining high standards of quality.

    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.
    • In-depth knowledge of scientific/technical writing, editing, and regulatory guidance (e.g., ICH).
    • Ability to interpret medical data and analyze its significance.
    • Proven project management skills, with experience negotiating and collaborating in cross-functional teams.
    • Leadership experience in guiding teams and mentoring junior professionals.
    • Advanced written and verbal communication skills with strong attention to detail.

    What You Can Expect from Us

    At Amgen, we are committed to your professional and personal growth. Alongside competitive total rewards plans aligned with industry standards, we foster a collaborative and supportive culture to help you thrive.

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

    Visit us at careers.amgen.com.

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