Position Summary:
MannKind Corporation is seeking a detail-oriented and highly organized Medical Writer to join our team. The Medical Writer will provide advanced scientific writing expertise and ensure the successful preparation of high-quality documents including but not limited to study protocols, CSRs, DSURS, IB, safety narratives, publications and submission documents. This role involves providing medical writing support for multiple compounds and projects within multiple therapeutic areas, potentially interfacing with external groups, and serving as the scientific writing expert for the department.
Essential Duties and Job Functions:
- 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.
Knowledge, Experience and Skills:
- BS/BA +12 / MS/MBA 8-10, PhD 5+
- Degree in science or medical related field. Master’s or PhD preferred.
- 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.
