Director Medical Writing

Work Schedule

Environmental Conditions

Job Description

Position Responsibilities

• Lead writing team in document prototyping and preparation processes to ensure:

(i) coordination and efficient use of messages between internal development plans/protocols/storyboard, etc, CTN and (s)BLA/NDA documentation, and

(ii) appropriate prioritization of critical versus non-critical path activities.

• Apply Lean Strategy throughout filing storyboard, document strategy development, document authoring & review & comments resolution; Provide expertise and leadership in keeping up to date with global Lean Writing Strategy and guiding/training China Scientific Writer.
• Participate in Development Teams, Filing Teams, and relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.

• Drive the development and manage the implementation of regulatory documentation strategy to meet time and quality performance goals for filing regulatory dossiers as planned by Development Teams/Filing Teams.
• Coordinate documentation activities of multi-functional authors, reviewers, and approvers; manage the document review process to maximize speed and quality on behalf of the assigned Development Team(s).
• Ensure documentation strategy is integrated to support filings, approvals, and/or other regulatory commitments in China.
• Critically review regulatory documents, key data texts and displays during dossier prototype creation and facilitate reaching a consensus at key findings/ final document review meeting.
• Influence the assigned development team(s) in tracking milestone activities, proactively identify opportunities & risks and propose preventative/mitigation actions for writing team and cross-function team alignment & implementation, in terms of dossier documentation activities, particularly the ones with a potential to impact the dossier quality or timelines.
• In conjunction with the team members, manage and coordinate responses to dossier-related health authority questions.
• In conjunction with appropriate disciplines, identify and ensure management of external documentation support when required.
• Contribute to and able to lead the development and/or optimization of effective documentation processes, standards, and templates as China Scientific Writing representative; implement the processes to support goals of assigned development team(s) and ensure maintenance of documentation standards.
• Apply expertise in non-drug projects as needed (China R&D Salon speaker, etc)
• Perform QC review on clinical documents.

Experience Requirement

PhD/MD/ PharmD or MS in a relevant scientific discipline with approximately 10 years of pharmaceutical regulatory documentation. At least five major filings (BLA /NDA / MAA / J-NDA / China NDA), preferably in multiple therapeutic areas and a strong depth and breadth of knowledge of the submission process and significant experience in writing high-level summary documents for global registrations.

Key Competency Requirement

• Bilingual language efficiency - fluent in both Chinese & English regulatory writing
• Experience in development of documentation strategy and leading and mentoring a team of writers in support of major regulatory submissions (CTNs, (s)BLA/NDAs).
• Demonstrated strong writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (eg, briefing documents, CTD summary documents, responses, pediatric submission documents).
• Ability to analyze and interpret complex data from a broad range of scientific disciplines and adapt it to document development and process improvement.
• Demonstrated critical thinking and ability to challenge the status quo.
• Thorough understanding of global pharmaceutical drug development and requirements for documentation authoring supporting regulatory submissions.
• Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
• Working knowledge of a document management system and knowledge of the document publishing/e-CTD process
• Capable of advising the risk of filling based on the data and having other options to avoid or minimize them as an expert of scientific writer.
• Excellent organizational communication, facilitation, and interpersonal skills in a cross-functional team.
• Skills to appropriately manage CROs or vendors; to collaborate with partners as needed.