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    Regulatory Writing Mgr

    Amgen
    5+ years
    Not Disclosed
    Hyderabad
    10 Dec. 14, 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

    Here’s a refined description for the Global Regulatory Writing Manager role at Amgen:

    Position: Global Regulatory Writing Manager

    Department: Global Regulatory Affairs & Strategy (GRAAS)
    Reporting to: Jennifer Vande Weghe
    Location: [Insert location if provided]

    About Amgen

    At Amgen, we are dedicated to improving lives by merging biology with cutting-edge technology. For over 40 years, we’ve pioneered innovations in the biotechnology industry, helping millions of patients live healthier, fuller lives. Leveraging human genetic data, we continue to push the boundaries of science and technology to deliver transformative therapies globally.

    Role Overview

    As the Global Regulatory Writing Manager, you will author, manage, and gain approval for high-quality scientific and regulatory submission documents. This includes maintaining global regulatory compliance while collaborating with cross-functional teams. In this role, you may also lead product submission writing activities, mentor junior writers, and contribute to departmental initiatives.

    Key Responsibilities

    Regulatory Document Development:

    • Author a wide range of regulatory documents, including:
      • Clinical Study Reports (CSRs)
      • Investigator Brochures
      • Protocols and Protocol Amendments
      • eCTD Module 2 Clinical Summary Documents
      • Informed Consent Forms (ICFs)
      • Briefing Documents, Pediatric Investigation Plans, and more.
    • Conduct formal reviews and approvals, adhering to standard operating procedures (SOPs).
    • Manage writing activities for product submissions (e.g., NDAs, BLAs, supplemental applications) with supervision.

    Team Collaboration and Leadership:

    • Serve as the functional area lead on key product teams, such as Global Regulatory Teams, Evidence Generation Teams, and Label Working Groups.
    • Provide input to Global Regulatory Plans and team goals.
    • Work with contract and freelance writers when necessary.

    Mentorship and Process Development:

    • Train and mentor junior writers.
    • Participate in departmental and cross-departmental initiatives to improve processes and standards.

    Project and Time Management:

    • Generate and manage document timelines with team input.
    • Maintain up-to-date knowledge of regulatory writing requirements and technologies.

    Required Skills and Qualifications

    Educational Qualifications:

    • Doctorate degree, OR
    • Master’s degree with 3+ years of directly related experience, OR
    • Bachelor’s degree with 5+ years of directly related experience, OR
    • Associate’s degree with 10+ years of directly related experience, OR
    • High school diploma/GED with 12+ years of directly related experience.

    Experience:

    • Minimum 5 years of medical writing experience in the biotech or pharmaceutical industry.
    • Hands-on experience with regulatory documents in Regulatory Affairs, Research, or Development.

    Technical Skills:

    • Strong proficiency with Microsoft Office and regulatory document management systems.
    • In-depth understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines.
    • Familiarity with complex SOPs, guidance documents, and work instructions.

    Soft Skills:

    • Exceptional written and verbal communication skills with meticulous attention to detail.
    • Ability to lead in team environments requiring negotiation, persuasion, and collaboration.
    • Proven project management and time management abilities.
    • Self-motivated, results-driven, and innovative.

    Why Join Amgen?

    Amgen fosters a culture of innovation, diversity, and inclusion. As a Global Regulatory Writing Manager, you’ll be at the forefront of biotechnology, playing a vital role in advancing groundbreaking therapies that improve patient outcomes.

    Equal Opportunity Statement

    Amgen is an Equal Opportunity Employer, committed to diversity in the workplace. We ensure that individuals with disabilities are provided reasonable accommodations during the employment process.

    Apply today to make an impact!

    Let me know if you'd like any further customization!

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