MindMed · 4 days ago
Associate Director, Medical Writing
United States
Full-time
Remote
Senior Level, Lead/Staff
$169K/yr - $194K/yr
5+ years expDefinium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company focused on developing innovative treatments for brain health disorders. The Associate Director of Medical Writing will be responsible for authoring clinical and regulatory documents, performing quality checks, and supporting clinical study execution while collaborating with cross-functional teams.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Authors routine clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, investigator's brochures, and sections of regulatory submissions) in partnership with cross-functional team with oversight
Performs quality checks of documents and data files
Performs technical edits and formatting of documents, maintains templates, SOPs, Style Guides, and work instructions
Communicates proactively and efficiently within the MW team and across other functional areas
Supports clinical study execution through expert review of study-level documents authored by other functions (e.g., study deviations, study manuals, consent forms, analysis plans, data outputs)
Coordinates and leads document submission workflows (eg, kick-off meetings, roundtables, reviews, quality control (QC) and other content activities, approvals) by managing issues and facilitating resolutions
Works with project management to develop 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 conducts literature searches
Reviews clinical trial registry postings for assigned studies
Stays 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
Maintains effective working relationships with contractors, vendors, and partners
Qualification
Required
Experience and knowledge in the preparation of documentation supporting global regulatory submissions
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 skills
Initiative and creativity in solving routine problems for individual documents and 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 ability to work effectively with a variety of personnel including contract medical writers
Bachelor's degree
5+ years of experience writing clinical regulatory documents
Preferred
Experience with marketing applications is a plus, but not required
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 and some fun fringe perks!
Company
MindMed
MindMed provides psychedelic-inspired medicines and therapies for substance abuse disorders and other mental illnesses.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$673.82MKey Investors
K2 HealthVenturesCanaccord Genuity Group
2025-10-29Post Ipo Equity· $225M
2024-08-09Post Ipo Equity· $75M
2024-03-07Post Ipo Equity· $175M
Leadership Team
Robert Barrow
CEO
Daniel Karlin
Chief Medical Officer
Recent News
2026-01-12
2025-11-24
2025-11-08
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