Job Information
Amgen Regulatory Operation Manager (including Writing Role) in Beijing, China
Job Summary
To author and gain approval of scientific and regulatory submission documents that comply with global regulatory standards.
To focus mainly on filing & submission of CTNs / MAAs / variations
Key Activities
Author the regulatory documents (With limited supervision):
Author regulatory submission documents, as assigned, mainly including, Briefing Documents, Responses to Questions, CSS of Protocol, China special addendum for eCTD Module 2 Clinical Summary Documents, and other regulatory documents
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
Serve as writing lead on product teams (e.g., China Product Team, China Regulatory Team)
May participate in training and mentoring of junior medical writers
May participate in departmental and cross-departmental initiatives, as appropriate
Generate document timelines, with team input
Keep abreast of relevant professional information and technology.
Filing and submission:
Lead submission in partnership with TA team
Coordinate and follow the dossier package preparation with CMC team and cross-functions
Analyze the gaps and needs for China RA in early phase submission
Arrange dossier package printing and binding to ensure the submission on time
Control the package filing strategy to facilitate simultaneous filing
Be responsible for managing the archiving dossiers, certificates and approval letters
Knowledge and Skills
Excellent written/oral communication skills and attention to detail in both English and Chinese
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
Local regulatory regulation knowledge
Good team player