Associate Director, Medical Writing

About the role

The Associate Director leads the medical writing strategy for one or more therapeutic areas within Clinical Development, acting as a strategic partner to senior clinical leadership. The role covers the efficient preparation of high-quality, strategically aligned medical writing deliverables that support clinical development, clinical safety and regulatory requirements, and includes global responsibilities with potential for global reports, global team participation and interaction with regulatory agencies in multiple regions. It reports to the Director of Medical Writing.

Key responsibilities

• Maintain a strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinical Safety Physicians on the clinical development strategy and the medical writing services needed.
• Lead cross-functional teams to build a messaging strategy across a program of work, such as a clinical submission.
• Critique product strategies (e.g., submission plans) against business and regulatory needs and identify where new or alternative arguments are needed.
• Prepare medical writing deliverables on time and within budget, and forecast, budget and allocate resources.
• Manage Senior Medical Writers, coaching, training and mentoring them.
• Ensure consistent information and messages across all documents in a clinical program, from initial plans through study documents to regulatory submissions or publications.
• Analyse proposed plans, programs and studies for their ability to deliver accurate, compelling information to the regulatory authority.
• Develop and communicate best practices, SOPs, templates, style guides and content guides, and drive continual improvement of in-house medical writing.
• Support other CR&D and CSL groups, work with medical writing partners (CROs, vendors) and take part in bid defense, contract development and vendor governance.

Required profile

• Minimum of 8 years of medical writing experience in the biopharmaceutical industry or a contract research organization.
• Minimum of 3 years in a supervisory role.
• Post-graduate qualifications (PhD or MD preferred).
• Demonstrated track record in cross-functional, multicultural and international clinical trial teams.

Required skills

• Comprehensive understanding of the clinical development process and of medical writing processes, standards and issues.
• Prior experience with submissions in Common Technical Document (CTD) format.
• Knowledge of eTechnology related to regulatory submission (eCTD, EDMS, Life Cycle Management).
• Expert Microsoft Office skills, especially word processing, tables, spreadsheets, presentations, graphics and templates.
• Fluent English with mastery of grammar and punctuation.