Full-Time Executive Director, Medical Writing
MapLight Therapeutics is hiring a remote Full-Time Executive Director, Medical Writing. The career level for this job opening is Manager and is accepting USA based applicants remotely. Read complete job description before applying.
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MapLight Therapeutics
Job Title
Executive Director, Medical Writing
Posted
Career Level
Full-Time
Career Level
Manager
Locations Accepted
USA
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Job Details
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
What You’ll Do: Reporting to the VP, Regulatory Affairs, the Executive Director, Medical Writing will establish the function and oversee internal and external medical writing resourcing to support authoring needs. The Executive Director will lead writing strategy, drive document content and organization, develop and manage timelines, and identify relevant stakeholders to help drive our mission to set a new standard of care for brain disorders.
Responsibilities:
- Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables.
- Lead writing strategy, drive document content and organization, develop and manage timelines, and identify relevant stakeholders.
- Collaborate with subject matter experts on document development and review.
- Author or manage others in the preparation of clear and concise clinical, nonclinical and regulatory documents.
- Responsible for ensuring the accuracy and quality of submission-ready documents using established and effective writing processes
- Coach, develop, and support employees in function.
- Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov.
- Develop and implement document templates, style standards, reference library, reviewer guidelines, and quality control checklists.
- Ensures development and maintenance of relevant SOPs and internal best practices.
- Has flexibility to react rapidly to changing situations/environment.
- Will plan strategically, anticipate problems, and recommend process improvements to address current and future needs
Qualifications:
- Bachelor of Science with significant relevant writing experience, or Bachelor degree in English or communications with significant relevant science experience.
- Minimum of 10 years of relevant medical/regulatory writing experience in the pharmaceutical industry required.
- Minimum of 5 years of regulatory document project management experience with extensive experience in working with collaborative, cross-functional teams.
- Extensive knowledge of English grammar and American Medical Association (AMA) style guide.
- Demonstrated experience mentoring medical writers, managing project work, and supervising internal and external writers/vendors.
- Demonstrated track record of contribution to successful regulatory components used in filings e.g., IND/CTAs, NDA/BLA/MAAs.
- Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology.
- Advanced knowledge of US and international regulations, requirements and guidance associated with scientific publications or regulatory document preparation and submissions.
- Knowledge and expertise with Common Technical Document content templates, electronic document management systems and information technology.
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Executive Director, Medical Writing at MapLight Therapeutics is
13th of October 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
USA
] applicants. .
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