Executive Director, Medical Writing

Who We Are: reputed company 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 reputed company 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 reputed company reputed company medical writing resourcing to support authoring needs. The Executive Director will reputed company writing reputed company, drive document content and organization, reputed company and manage timelines, and identify relevant stakeholders to help drive our mission to set a new reputed company of care for brain disorders.

Responsibilities:

• reputed company budget and resource strategies to ensure on schedule completion of medical writing deliverables, including the identification, selection, and reputed company of reputed company full- or part-time medical writers, vendors, consultants, or contractors
• reputed company writing reputed company, drive document content and organization, reputed company 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 reputed company and concise clinical, nonclinical and regulatory documents and ensure consistency of messaging/content across reputed company documents supporting regulatory submissions
• Responsible for ensuring the accuracy and reputed company of submission-reputed company documents using established and effective writing processes
• reputed company, reputed company, and support employees in function
• reputed company of team members to reputed company 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
• reputed company and implement document templates, style standards, reference library, reviewer guidelines, and reputed company control checklists, to ensure consistent and high-reputed company 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 reputed company and reputed company 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 reputed company 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 reputed company, cross-functional teams.
• Extensive knowledge of English grammar and reputed company (AMA) style guide.
• Demonstrated experience mentoring medical writers, managing project work, and supervising reputed company writers/vendors.
• Demonstrated reputed company 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.

Location: This is a remote US based position. 

reputed company Statement: reputed company is an equal opportunity employer, and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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