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481 Amgen Jobs

Director Global Regulatory Writing

10-15 years

Hyderabad / Secunderabad

1 vacancy

Director Global Regulatory Writing

Amgen

posted 26d ago

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Director Global Regulatory Writing




Live

What you will do

Lets do this. Lets change the world. In this vital role you will oversee the regulatory writing staff and projects within one or more therapeutic areas.
  • Prepare and oversee the review and approval of scientific and regulatory submission documents.
  • Serve as functional area lead on product teams.
  • Maintain key business relationships with cross-functional product team members and appropriate management staff across the Amgen R&D organization.
  • Provide expertise and guidance on document design and principles of good medical writing to individual staff, the department, product teams, and other functional areas.
  • Supervise, train, coach, and mentor regulatory writers.
  • Oversee the work of contract writers and CROs assigned to program documents.
  • Manage and implement day-to-day departmental activities and operations, including hiring; resourcing projects; leading or participating in cross-functional process development, training, and oversight; business process ownership; and meeting management.
  • Assist executive leadership with resource and budget planning and other department management activities, as needed.
  • What we expect of you

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

    Required experience includes:

    Doctorate degree and 4 years of directly related experience

    OR

    Masters degree and 8 years of directly related experience

    OR

    Bachelors degree and 10 years of directly related experience

    The successful candidate will have the following skills:
  • Experience reading, understanding, and applying regulations to constantly changing environment
  • Proven leader in a team environment which requires motivation, negotiation, persuasion, collaboration, and analytical judgment
  • Expertise in analyzing scientific data and interpreting its significance in practical applications
  • Excellent written/oral communication skills and attention to detail
  • Superior time and project management skills
  • Self-starter demonstrating perseverance with a drive for results
  • Strong management and supervisory skills with previous experience developing and delegating to direct reports
  • Advanced knowledge of scientific writing and editing and a detailed knowledge of the clinical development process for new compounds
  • Advanced knowledge of related regulatory/industry considerations and guidelines, compliance issues, and/or issues affecting scientific discovery
  • Advanced understanding and application of principles, concepts, theories and standards of scientific/technical field
  • Recognized as a functional-area/subject-matter expert within defined subject area
  • Applies expert knowledge and broad understanding of multiple disciplines to achieve efficiencies
  • Understands the core business process and purpose of the functional area in Amgen's commercialization process




  • Thrive

    What you can expect of us

    As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

  • Employment Type: Full Time, Permanent

    Read full job description

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    What people at Amgen are saying

    Director salary at Amgen

    reported by 3 employees with 16-23 years exp.
    ₹50 L/yr - ₹100 L/yr
    41% more than the average Director Salary in India
    View more details

    What Amgen employees are saying about work life

    based on 10 employees
    63%
    86%
    60%
    50%
    Flexible timing
    Monday to Friday
    No travel
    Night Shift
    View more insights

    Amgen Benefits

    Submitted by Company
    Health Insurance
    Child care
    Education Assistance
    Employee volunteer program and company matching donation program
    Flexible work environment
    Competitive base pay and annual bonus opportunities
    Submitted by Employees
    Health Insurance
    International Relocation
    Child care
    Gymnasium
    Cafeteria
    Work From Home +6 more
    View more benefits

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