Global Regulatory Writing Manager
Department: Global Regulatory Affairs & Strategy (GRAAS)
Role GCF: 5
Hiring Manager: Jennifer Vande Weghe
About Amgen
Amgen is a biotechnology leader dedicated to harnessing biology and technology to combat serious diseases. With over 40 years of pioneering innovation, Amgen is committed to discovering, developing, manufacturing, and delivering medicines that improve the lives of millions. Through the integration of technology and human genetic data, Amgen pushes the boundaries of medicine.
Role Description
The Global Regulatory Writing Manager will author and gain approval for regulatory submission documents, ensuring compliance with global regulatory standards. This role involves collaborating with cross-functional teams and potentially leading writing activities for product submissions, mentoring junior writers, and assisting with departmental tasks.
Roles & Responsibilities
Regulatory Document Authoring: Create regulatory submission documents such as:
Clinical Study Reports
Investigator Brochures
Responses to Questions
Protocols & Protocol Amendments
Informed Consent Forms
Clinical Overview Addenda
eCTD Module 2 Clinical Summary Documents
Briefing Documents
Pediatric Investigation Plans
Other regulatory documents as needed.
Document Review & Approval: Manage the formal review and approval of authored documents, ensuring compliance with SOPs.
Regulatory Writing Management: Under supervision, manage writing activities for product submissions, including new and supplemental drug applications/biologics license applications.
Functional Area Leadership: Serve as a functional area lead on product teams such as:
Global Regulatory Team
Evidence Generation Team
Global Safety Team
Label Working Group
Cross-functional Collaboration: Provide functional input for global regulatory planning and team goals.
Training & Mentoring: Help train and mentor junior writers and assist with cross-departmental initiatives.
Timeline Management: Create and manage document timelines with team input.
Stay Updated: Keep current on relevant professional information and technology.
Functional Skills
Proficiency with MS Office: Skilled in word processing and other Microsoft Office tools.
Scientific/Technical Writing: Extensive knowledge of scientific/technical writing and clinical development processes.
Regulatory Knowledge: Strong understanding of ICH and GCP guidance, SOPs, and work instructions.
Document Management: Capable of handling complex regulatory documents and adhering to global standards.
Soft Skills
Communication: Excellent written and oral communication skills with strong attention to detail.
Leadership: Ability to lead teams, negotiate, collaborate, and use analytical judgment.
Time Management: Proficient in time and project management skills.
Initiative: Self-starter with a strong drive to achieve results.
Basic Qualifications
Education:
Doctorate degree, OR
Master’s degree + 3 years of relevant experience, OR
Bachelor’s degree + 5 years of relevant experience, OR
Associate’s degree + 10 years of relevant experience, OR
High school diploma/GED + 12 years of relevant experience.
Experience:
5+ years in medical writing within the Biotech/Pharmaceutical industry, with experience in regulatory documents in Regulatory Affairs, Research, Development, or a related area.
Equal Opportunity Statement
Amgen is committed to equal opportunity and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. We also provide reasonable accommodations for individuals with disabilities during the application process, in job functions, and in receiving other benefits and privileges of employment.
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Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |North Carolina :
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Prague |Republic of Egypt :
Cairo |South Yorkshire :
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Leeds | Harlow | Salt Lake City | London | Maidenhead | Stirling | United Kingdom |Estonia :
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