Associate Director, Medical Writer

Essential Duties and Job Functions

• Cook up and drive the review, approval, and production of writing projects, arranging meetings with cross-functional teams.
• Ensure effective communication among project team members and contributors, holding them accountable to agreed-upon project dates.
• Lead strategic document preparation for INDs, NDAs, and briefing documents.
• Establish best practices, workflow infrastructure/templates, and standards to enhance consistency and quality across all regulatory and scientific documents.
• Oversee the development and finalization of high-quality, scientifically accurate, ICH-compliant documents, including clinical study protocols and reports, Investigator Brochures, Periodic Safety Updates, patient narratives, and manuscripts for peer-reviewed publications.
• Stay abreast of global regulatory requirements and guidelines (FDA, EMA, PMDA, ICH, etc.), ensuring company compliance and best practices.
• Partner with cross-functional teams, including clinical development, medical affairs, regulatory affairs, safety to ensure seamless integration of medical writing.
• Serve as the medical writer representative on project teams.
• Write and edit scientific, clinical, or abstracts, posters, presentations, digital enhancements, and manuscripts aligned with scientific narrative and objectives.
• Complete reviews, quality checks and approvals.
• Summarize results presented in graphical, tabular, and/or listing format.
• Interpret complex clinical data and convert it into clear, concise, and engaging scientific content for diverse audiences.

Knowledge, Experience and Skills

• BS/BA +12 / MS/MBA 8-10, PhD 5+
• Minimum of 7 years relevant industry experience in medical writing in sponsor/CRO setting or academia, or related areas such as quality, regulatory submissions, publications, clinical research, or product support/R&D.
• Knowledge of US and international regulations, requirements, and guidance associated with writing projects.
• Excellent written and oral communication skills, attention to detail, and ability to correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
• Extensive experience working with collaborative, cross-functional teams.
• Develop and/or update document templates, work instructions, style guides, and department-related processes (SOPs).
• Experience working on publications for multiple therapeutic areas, endocrinology and pulmonology preferred.
• Understanding of publication/scientific communication guidelines.
• Ability to provide strategic oversight while managing multiple priorities in a fast-paced environment.
• Deep understanding of ICH-GCP guidelines and other relevant regulatory requirements.
• Strategic thinker with strong execution skills.

Pay Range

$148,000 - $222,000 per year