Director, Medical Writing

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.

Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.

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
  
  

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
  
  

The starting base pay range for this position is $184,402.00 - $215,190.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 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 and some fun fringe perks!