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