Medical Writing Director

Summary

Join MindMed, a clinical-stage biopharmaceutical company, as a Medical Writer contributing to the development of novel treatments for brain health disorders. You will author and review clinical and regulatory documents, collaborating with cross-functional teams. This role requires extensive experience in medical writing, regulatory submissions, and a strong understanding of clinical research. A Bachelor's degree and 10+ years of relevant experience are essential. MindMed offers a competitive salary, comprehensive health benefits, 401(k) matching, flexible time off, and generous parental leave.

Requirements

• Experience and knowledge in the preparation documentation supporting global regulatory submissions. Experience with marketing applications is a plus, but not required
• Experience producing high-quality scientific/medical documents
• Ability to understand, analyze, interpret, and summarize clinical and scientific data
• Basic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
• Basic project management and organizational skills
• Initiative and creativity in solving routine problems for individual documents and in identifying process improvements within the Medical Writing department
• Attention to detail related to consistency, grammar, syntax, and scientific accuracy
• Basic computer skills related to word processing, templates, table/figure creation, and literature searches
• Knowledge and understanding of applicable US and global regulations and guidance
• Knowledge of eCTD content/format requirements
• Excellent verbal and written communication skills
• Strong organizational skills
• Strong interpersonal skills and the ability to work effectively with a variety of personnel including contract medical writers
• Bachelor's degree
• 10+ years of experience writing clinical regulatory documents

Responsibilities

• Authors routine clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, and investigator's brochures, and sections of regulatory submissions) in partnership with cross-functional team with oversight
• Supports clinical study execution through expert review of study-level documents authored by other functions (e.g., study deviations, analysis plans, data outputs)
• Coordinate and lead document roundtables, reviews, approvals, quality control (QC) and other document content issues and overall questions during the authoring process
• Develops timelines for documents and communicates with team members to maintain awareness of expectations, milestones, and deliverables
• Collaborates with cross-functional team to review study results
• Contributes scientific knowledge and analytical skills to the production of documents
• Participates in developing key messages for routine documents and conduct literature searches
• Reviews clinical trial registry postings for assigned studies
• Review and update style guide to ensure consistency across documents
• Stay current with respect to key global guidance documents, regulations, or directives
• Works effectively with an electronic document management system and related tools to develop clinical documents
• Maintain effective working relationships with contractors, vendors and partners

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave
• Employees in this role may be entitled to additional compensation, including bonus and equity