Description
**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
