Regulatory Writing Manager

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-28920
Amgen is seeking a Regulatory Writing Manager. This role will be based on our main corporate campus in Thousand Oaks, CA or could be managed as a remote work assignment.
Job responsibilities include:
Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards
Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 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 (e.g., RTQs, PIP, white papers, breakthrough therapy applications, orphan drug applications)
Manage 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 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
Basic Qualifications
Doctorate degree
Master's degree and 3 years of Writing Regulatory or scientific submission/documents experience
Bachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experience
Associate's degree and 10 years of Writing Regulatory or scientific submission/documents experience
High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience
Preferred Qualifications
MS or higher degree in biology, chemistry or other scientific discipline
5+ years of experience in writing clinical and regulatory documents
Ability to effectively operate in an environment that involves 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 (e.g., 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
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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