Executive Director, Medical Writing

Join MapLight Therapeutics: Executive Director, Medical Writing

Are you a seasoned medical writing leader passionate about transforming the lives of individuals with central nervous system disorders? MapLight Therapeutics, a pioneering clinical-stage biotech company, is seeking a highly skilled and motivated Executive Director, Medical Writing to lead our medical writing function.

About MapLight Therapeutics

At MapLight Therapeutics, we’re dedicated to discovering and developing innovative therapies for brain disorders. We leverage cutting-edge technologies, including optogenetics, in vivo physiology, and spatial transcriptomics, to identify novel drug targets and advance effective treatments that address unmet needs in psychiatric care. We strive to set a new standard for how brain disorders are treated.

The Opportunity: Executive Director, Medical Writing

As the Executive Director, Medical Writing, you will report directly to the VP, Regulatory Affairs, and be instrumental in establishing and overseeing our internal and external medical writing resources. You will be responsible for leading the medical writing strategy, driving document content and organization, managing timelines, and collaborating with key stakeholders to achieve our mission.

Key Responsibilities

• Develop and manage budget and resource strategies for timely completion of medical writing deliverables, including the selection and oversight of medical writers (full-time, part-time, vendors, consultants, and contractors).
• Lead the writing strategy, driving document content and organization, developing and managing timelines, and engaging relevant stakeholders.
• Independently author or manage the preparation of clear, concise, and accurate clinical, nonclinical, and regulatory documents, ensuring consistency across all regulatory submissions.
• Ensure the accuracy and quality of submission-ready documents through established and effective writing processes.
• Coach, develop, and support the growth of team members.
• Oversee team members in performing weekly literature searches.
• Manage clinical trial transparency and disclosures, including results posting on ClinicalTrials.gov, EudraCT, and similar databases, in collaboration with Regulatory Affairs.
• Develop and implement document templates, style standards, reference libraries, reviewer guidelines, and quality control checklists for consistent, high-quality deliverables.
• Ensure the development and maintenance of relevant SOPs and internal best practices.
• Demonstrate flexibility to adapt to changing situations, proactively plan, anticipate problems, and recommend process improvements to address current and future needs.
• Attend occasional in-person team meetings (travel required).

Qualifications

• Bachelor of Science (B.S.) with significant relevant writing experience, or a Bachelor’s degree in English or Communications with substantial relevant science experience.
• A relevant advanced degree (e.g., MS, PharmD, PhD, MD) is strongly preferred.
• American Medical Writing Association (AMWA) certification or other relevant certifications are a plus, particularly with a focus on Pharmaceutical Writing.
• A minimum of 10 years of relevant medical/regulatory writing experience within the pharmaceutical industry or in a related field such as regulatory affairs, clinical research, or product support/R&D is required.
• At least 5 years of regulatory document project management experience, including extensive experience collaborating with cross-functional teams.
• Exceptional knowledge of English grammar and the American Medical Association (AMA) style guide.
• Proven experience mentoring medical writers, managing project work, and supervising both internal and external writers/vendors.
• Demonstrated track record of contributing to successful regulatory filings (e.g., IND/CTAs, NDA/BLA/MAAs).
• Solid understanding of drug development, clinical research, study design, biostatistics, regulatory affairs, and medical terminology.
• Advanced knowledge of US and international regulations, requirements, and guidance related to scientific publications and regulatory document preparation/submissions.
• Expertise in Common Technical Document (CTD) content templates, electronic document management systems, and information technology.

Location & Equal Opportunity

This is a remote, US-based position offering flexibility and work-life balance.

MapLight Therapeutics is an equal opportunity employer committed to creating an inclusive and diverse work environment. We consider all qualified applicants without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.