Regulatory Writing Senior Manager

Job Summary

• To prepare (author) scientific and regulatory submission documents that comply with global regulatory standards and China local regulation requirements.
• To accelerate China local pipeline readiness for simultaneous development and filing globally

Key Activities

• Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development
• 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 (eg, Responses to Questions, Pediatric Investigation Plans, breakthrough therapy applications, priority review application, etc)
• Conduct the review and approval process of authored documents, following applicable standard operating procedures.
• Manage study timelines for regulatory documents and regulatory submission strategy. Cooperate with cross-functional teams to align on the authoring strategy. Complete the assigned files of high quality within aligned timeline.
• Ability to independently work and ensure quality of regulatory submission documents at all stages of development
• Lead regulatory writing activities for complex product submissions as assigned, including new and supplemental drug applications / biologics license applications.
• Act as regulatory writer representative in product teams (e.g., China Product Team, Global Regulatory Team, Evidence Generation Team, etc)
• Provide expertise and guidance on document design and principles of good regulatory writing to the department and product teams
• Participate in departmental meetings, as well as local/global cross-functional initiatives, as appropriate
• Establish healthy collaborative relationship with study teams through daily work to accelerate China development.
• Supervise the work of contract and freelance writers and mentor junior medical writers when assigned.

Knowledge and Skills

• Experience in writing clinical and regulatory documents
• Ability to analyze medical data and interpret its significance
• Advanced written/oral communication skills and attention to detail in both English and Chinese
• Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds
• Advanced knowledge of related China local regulatory regulation and international regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance
• Ability to effectively operate and 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.
• 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
• Proficiency with word processing and other Microsoft Office Programs
• Proficient time and project management skills
• Good team player. Ability to build and maintain good relationship within working team

Education & Experience

• Doctor degree and 3-5 years of Writing Regulatory or scientific submission/documents experience OR
• Master’s degree and 8-10 years of Writing Regulatory or scientific submission/documents experience
• >10 years industry working experience
• Pharmaceuticals or medical education background