Job Information
Amgen Regulatory Writing Senior Manager in Beijing, China
Group Purpose
To prepare (author) scientific and regulatory submission documents that comply with global regulatory standards and local regulation requirements
To ensure to accelerate local pipeline readiness and simultaneous development and filing globally
Job Summary
Lead writing activities for complex product submissions
Provide writing area expertise
Train and mentor more junior writers
Key Activities
Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications / biologics license applications
Serve as regulatory writing area lead on product teams (e.g., China Product Team, Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for China Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead writing in local function and local/global cross-functional initiatives, as appropriate
Generate document timelines
Knowledge and Skills
Excellent written/oral communication skills and attention to detail in both English and Chinese
Strong knowledge of local regulatory regulation/HA requirements on submission documents
Proficiency with word processing and other Microsoft Office Programs
Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds
Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment
Ability to understand and follow complex standard operating procedures (SOP’s), guidance documents, and work instructions
Proficient time and project management skills
Self-starter with a drive and perseverance to achieve results
Good team player
Education & Experience (Basic)
Master degree
12 years industry working experience
8-10 years of directly related writing experience in Regulatory Affairs, Medical, Research, Development or related area
Pharmaceuticals or medical education background
Education & Experience (Preferred)
Doctor degree
Amgen
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