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Executive Director, Medical Writing

2 months ago

burlington, United States MapLight Therapeutics, Inc. Full time

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, including the identification, selection, and oversight of qualified full- or part-time medical writers, vendors, consultants, or contractors
  • 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
  • Independently author or manage others in the preparation of clear and concise clinical, nonclinical and regulatory documents and ensure consistency of messaging/content across all documents supporting regulatory submissions
  • Responsible for ensuring the accuracy and quality of submission-ready documents using established and effective writing processes
  • Coach, develop, and support employees in function
  • Oversight of team members to perform weekly literature searches
  • Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs
  • Develop and implement document templates, style standards, reference library, reviewer guidelines, and quality control checklists, to ensure consistent and high-quality deliverables
  • 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
  • Willing to travel for occasional in-person team meetings


Qualifications:

  • Bachelor of Science with significant relevant writing experience, or Bachelor degree in English or communications with significant relevant science experience
  • A relevant advanced degree (e.g. MS, PharmD, PhD, MD) is preferred
  • American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing
  • Minimum of 10 years of relevant medical/regulatory writing experience in the pharmaceutical industry required, or in a related area such as regulatory, clinical research, or product support/R&D
  • 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 and ability to advise teams regarding compliance with regulations
  • Knowledge and expertise with Common Technical Document content templates, electronic document management systems and information technology



MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment 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.