Associate Director, Medical Writing
MindMed
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $168,762 - $194,140 per year
Job Level
About the role
- 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
Requirements
- Experience and knowledge in the preparation of 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 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
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!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical study protocolsclinical study reportsregulatory submissionsscientific/medical document preparationbiostatisticspharmacokineticseCTD content/format requirementsdata analysisliterature searchesdocument quality control
Soft Skills
attention to detailinitiativecreativityorganizational skillsinterpersonal skillscommunication skillsproblem-solvingcollaborationproject managementproactive communication