Director, Medical Writing

• Prepare and/or manage complex marketed and development programs at the portfolio level.
• Directly supervise Medical Writing program leads and respond to Medical Writing issues with internal cross-functional teams and external development partners.
• Contribute to the department’s long-term growth strategy.
• Ensure standard procedures are followed across and within projects.
• Synchronize project prioritization.
• Represent Medical Writing in meetings with governance committees, regulatory agencies, and external development partners.
• Maintain knowledge of evolving/emerging industry standards and establish medical writing best practices.
• Prepare clinical and regulatory documents and packages, including protocols and amendments, CSRs, IBs, INDs/CTAs, and submissions.
• Lead planning, development, and delivery of documents according to ICH guidelines, company SOPs, templates, and regulatory requirements.
• Support development and maintenance of SOPs and templates.
• Analyze and synthesize complex scientific information and ensure document scientific accuracy and consistency.
• Develop and integrate messaging and medical writing strategy across therapeutic areas and/or disease states.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Clinical Operations SMEs.
• Participate in regulatory submission planning, timelines, and document development.
• Manage and/or oversee in-house and contractor/vendor medical writers.
• Mentor junior writers and provide professional development guidance.
• Serve as Medical Writing liaison for one or more Functional Service Providers when needed.
• Provide mentoring and career development to direct reports.
• Review statistical analysis plans and clinical data reports incorporated into CSRs, IBs, and other data-related documents.
• Provide strategic input to TFL outputs to streamline TFL production.
• Lead departmental initiatives as necessary.

Requirements

• Minimum of BSc + 12 years’ experience in Medical Writing, or Advanced degree + 7 years’ experience in Medical Writing (pharmaceutical, biotechnology, or CRO setting)
• Experience with global regulatory submissions (e.g. BLA/NDA, MAA)
• Familiarity with eCTD format and relationships between documents
• Familiarity with ICH, FDA, and EMA guidelines and regulations, as well as public disclosure requirements for documents
• Proven experience authoring documents and leading teams through the authoring process
• Strong project management skills with the ability to prioritize and manage multiple projects in a fast-paced environment
• SME in MS Word
• Proficiency in document management systems (Veeva, SharePoint)
• Experience in managing and/or mentoring other medical writers or external vendors preferred
• Exceptional written and communication skills
• Experience working in a matrix environment and collaborating with clinical teams
• Strong regulatory writing experience
• Expert knowledge of global requirements related to clinical regulatory documentation supporting Phase 1-4 clinical development
• Demonstrated management, scientific, and customer-focused leadership skills

Core Competencies

Demonstrates extensive expertise in Medical Writing, including authoring clinical and regulatory documents in compliance with ICH, FDA, and EMA guidelines. Proven ability to lead teams, manage projects, and mentor junior writers while ensuring scientific accuracy and adherence to industry standards.

Highest-signal resume keywords

• Medical Writing Expertise
• Global Regulatory Submissions
• Project Management Skills
• MS Word Proficiency
• Document Management Systems

ATS Optimization Keywords

Hard Skills

• Medical Writing
• Clinical Document Preparation
• Regulatory Writing
• Document Authoring
• Project Prioritization
• Scientific Analysis
• ECTD Format Familiarity
• ICH Guidelines Knowledge
• FDA Regulations Knowledge
• EMA Guidelines Knowledge

Soft Skills

• Exceptional Written Communication
• Leadership Skills
• Mentoring Ability
• Collaboration Skills
• Customer-Focused Approach

Industry Keywords

• Pharmaceutical
• Biotechnology
• CRO
• Clinical Development
• Regulatory Affairs

Tools & Technologies

• Veeva
• SharePoint
• Document Management Systems