Director of Medical Writing

The Director of Medical Writing is a senior leadership role responsible for overseeing the strategic direction, management, and execution of medical writing activities across clinical, regulatory, and publication-related projects. This position will play a critical role in ensuring that all medical writing deliverables meet the highest standards of quality, scientific rigor, and regulatory compliance. The Director will lead a team of medical writers, collaborate with key stakeholders, and drive process improvements, all while contributing to the success of the company’s clinical and regulatory goals. 

• Leadership & Strategy: 
  • Develop and execute the strategic vision for the Medical Writing department, aligning with company objectives and industry standards.
  • Lead, mentor, and manage a team of medical writers and medical writing managers, fostering a high-performance culture and ensuring professional development and growth.
  • Work closely with senior leadership to ensure the medical writing team is resourced appropriately to meet project needs and timelines.
• Medical Writing Oversight: 
  • Oversee the preparation of all types of scientific and regulatory documents, including clinical study protocols, clinical study reports (CSRs), regulatory submissions (e.g., INDs, NDAs, BLAs), Investigator's Brochures, and other critical medical       communications.
  • Ensure that documents are scientifically accurate, clear, and compliant with regulatory guidelines, corporate style, and industry standards (e.g., ICH, GxP).
  • Review and approve major documents to ensure alignment with overall scientific and regulatory strategy.
• Cross-Functional Collaboration: 
  • Collaborate with clinical development, regulatory affairs, biostatistics, pharmacovigilance, and other internal stakeholders to ensure seamless development and delivery of high-quality medical writing documents.
  • Serve as the primary point of contact between the medical writing team and other functional departments for all major regulatory and clinical writing activities.
  • Provide expert medical writing input into the development of clinical development plans, regulatory submission strategies, and scientific communication strategies.
• Regulatory and Compliance Leadership: 
  • Ensure all medical writing deliverables comply with regulatory guidelines, ethical standards, and industry best practices.
  • Maintain a deep understanding of evolving regulatory requirements and ensure the medical writing team is aligned with current FDA, EMA, ICH, and other global regulatory expectations.
  • Support the preparation and submission of regulatory documents, including CTAs, INDs, NDAs, BLAs, and global health authority interactions.
• Quality Control & Process Improvement: 
  • Define and implement best practices and standard operating procedures (SOPs) for medical writing across the       organization.
  • Develop, maintain, and improve medical writing templates, checklists, and style guides to ensure consistency and quality.
  • Continuously assess and optimize the medical writing process to improve efficiency, reduce errors, and enhance document quality.
• Publications and Scientific Communications: 
  • Oversee the preparation of manuscripts, abstracts, posters, and presentations for peer-reviewed publications and scientific conferences.
  • Ensure alignment of publication strategies with clinical and regulatory goals and oversee manuscript development, submission, and publication timelines.
• Training & Development: 
  • Provide leadership in the recruitment, training, and development of medical writing staff to ensure a high level of competency and expertise.
  • Stay current with emerging trends, regulatory guidelines, and best practices in medical writing, and provide training to the team as needed.
• Budget & Resource Management: 
  • Manage the department’s budget, including allocating resources appropriately for ongoing projects and initiatives.
  • Ensure that projects are completed on time and within budget, making adjustments to team or resource allocation as necessary.

Qualifications

• Education: 
  • Advanced degree (PhD, MD, PharmD, MS, or equivalent) in a scientific discipline (e.g., life sciences, pharmacology, medical sciences) required.
• Experience: 
  • Minimum of 8-10 years of medical writing experience in the pharmaceutical, biotechnology, or healthcare industry, with at least 5 years in a leadership or senior management role.
  • Proven experience in overseeing complex regulatory submissions, clinical study documentation, and scientific publications.
  • In-depth knowledge of global regulatory requirements, ICH guidelines, GxP, and medical writing standards.
• Skills: 
  • Strong leadership and team management skills, with a demonstrated ability to build and mentor high-performing teams.
  • Excellent written and verbal communication skills, with the ability to convey complex scientific and regulatory information in a clear, concise, and accessible manner.
  • Strong project management skills with experience managing multiple projects, timelines, and resources.
  • Advanced knowledge of medical writing tools (e.g., Microsoft Word, EndNote, Reference Manager, Adobe Acrobat) and regulatory submission platforms.
• Certifications: 
  • Certification in Medical Writing (e.g., from the American Medical Writers Association or equivalent) is highly desirable but not required.

Additional Skills

• Strong understanding of clinical trial design, statistical analysis, and clinical data interpretation.
• Experience in managing publications, including working with authors, journals, and conference organizers.
• Ability to represent the company at meetings with regulatory agencies, health authorities, and scientific conferences.
• Proven ability to manage high-pressure situations and meet tight deadlines.