Regulatory Writing Manager

Amgen Inc.

3.6

(9)

United States (Remote)

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-176931

    Position summary

    the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4)

    • Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives
    • Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications)
    • Lead study timelines for regulatory documents and regulatory submission strategy
    • Act as a functional area representative and lead on product teams
    • Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance
    • Ensure quality of regulatory submission documents at all stages of development
    • Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams
    • Participate in departmental meetings, as well as departmental and cross-departmental initiatives

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
    Basic Qualifications:

    Doctorate degree
    Or

    Master's degree and 3 years of Writing Regulatory or scientific submission/documents experience
    Or

    Bachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experience
    Or

    Associate's degree and 10 years of Writing Regulatory or scientific submission/documents experience
    Or

    High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience
    Preferred Qualifications:

    • Masters or higher degree in biology, chemistry, or other scientific field
    • 5+ years in writing clinical and regulatory documents
    • Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment
    • Ability to analyze medical data and interpret its significance
    • Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance
    • Strong written/oral communication skills and attention to detail
    • Understanding and application of principles, concepts, theories, and standards of scientific/technical field
    • Strong time and project management skills, engaging approach, and perseverance with a drive for results
    • Leadership skills and ability to guide and influence the work of others
    • Strong leadership in a collaborative team environment

    Thrive

    What you can expect of us

    As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

    Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

    • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
    • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
    • Stock-based long-term incentives
    • Award-winning time-off plans and bi-annual company-wide shutdowns
    • Flexible work models, including remote work arrangements, where possible

    Apply now

    for a career that defies imagination

    Objects in your future are closer than they appear. Join us.
    careers.amgen.com

    Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

    Salary Range
    113,860.00 USD - 139,338.00 USD

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging