Associate Director, Medical Writer
- Westlake Village, CA
- $144,000-216,000 per year
- Permanent
- Full-time
- Coordinate and lead the review, approval, and production of writing projects, arranging and driving review meetings with cross-functional teams.
- Ensure effective communication among project team members and contributors, holding them accountable to agreed-upon project dates.
- Leads 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.
- Lead and oversee medical writing project timelines, ensuring alignment with broader corporate milestones.
- 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.
- Degree in science or medical related field. Master's or PhD preferred.
- Minimum of 5 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.