Regulatory Writing Senior Manager

Amgen Inc.

3.6

(9)

Hyderabad, India

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-201960

    Position summary

    l area representative and lead on product teams

    • Manage, train and mentor medical writers

    • Manage the work of GRW staff

    • 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 guidance 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, as appropriate

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

    Basic Qualifications:

    • Doctorate degree and 2 years of Writing Regulatory or scientific submission/documents experience OR

    • Master's degree and 8 to 10 years of Writing Regulatory or scientific submission/documents experience OR

    • Bachelor's degree and 10 to 14 years of Writing Regulatory or scientific submission/documents experience OR

    • Diploma and 14 to 18 years of Writing Regulatory or scientific submission/documents experience

    Preferred Qualifications:

    • BS, MS or higher degree in biology, chemistry or other scientific discipline

    • Experience in writing clinical and regulatory documents

    • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment

    • Ability to analyze medical data and interpret its significance

    • Advanced knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance

    • Advanced 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, negotiating skills, and perseverance with a drive for results

    • Knowledge of management skills and supervising the work of others

    • Strong leadership in a team environment

    • Strong negotiator

    • Experience in mentoring, training, and directing others

    What you can expect of us

    As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

    In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

    Apply now

    for a career that defies imagination

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

    .

    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