MannKind Corporation
Associate Director, Medical Writer
MannKind Corporation, Westlake Village, California, United States, 91361
Join to apply for the
Associate Director, Medical Writer
role at
MannKind Corporation 1 day ago Be among the first 25 applicants Join to apply for the
Associate Director, Medical Writer
role at
MannKind Corporation Get AI-powered advice on this job and more exclusive features. This range is provided by MannKind Corporation. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $144,000.00/hr - $216,000.00/hr 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 you're looking to make a real impact in a fast-paced, purpose-driven biotech environment, MannKind is the place for you.
If you want to know about the requirements for this role, read on for all the relevant information.
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. 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.
Pay Range:
$144,000 - $216,000 per hourSeniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionHealth Care Provider IndustriesPharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at MannKind Corporation by 2x Get notified about new Associate Medical Director jobs in
Westlake Village, CA . Santa Monica, CA $225,000.00-$250,000.00 1 month ago Sweetwater Veterinary Clinic - Medical DirectorAssociate Director to Director, Statistical Programming Westlake Village, CA $180,000.00-$210,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Associate Director, Medical Writer
role at
MannKind Corporation 1 day ago Be among the first 25 applicants Join to apply for the
Associate Director, Medical Writer
role at
MannKind Corporation Get AI-powered advice on this job and more exclusive features. This range is provided by MannKind Corporation. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $144,000.00/hr - $216,000.00/hr 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 you're looking to make a real impact in a fast-paced, purpose-driven biotech environment, MannKind is the place for you.
If you want to know about the requirements for this role, read on for all the relevant information.
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. 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.
Pay Range:
$144,000 - $216,000 per hourSeniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionHealth Care Provider IndustriesPharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at MannKind Corporation by 2x Get notified about new Associate Medical Director jobs in
Westlake Village, CA . Santa Monica, CA $225,000.00-$250,000.00 1 month ago Sweetwater Veterinary Clinic - Medical DirectorAssociate Director to Director, Statistical Programming Westlake Village, CA $180,000.00-$210,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr