Associate Director, Medical Writer
Associate Director, Medical Writer
Posted on :
03-06-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
03-06-2025
Job Description
At MannKind we are driven by a mission to give people control of their health and the freedom to live life. We develop therapeutic products and devices that address unmet needs in diabetes rare lung diseases and other chronic conditions. Our people are passionate forward-thinking and committed to improving patient lives. If youre looking to make a real impact in a fast-paced purpose-driven biotech environment MannKind is the place for you.
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:
- Degree in science or medical related field. Masters 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.
Required Experience:
Director
Employment Type
Full Time
Key Skills
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