Associate Director, Medical Writing - Remote

Overview

Definium Therapeutics, formerly known as Mind Medicine, 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.

In Short

• Authors routine clinical and regulatory documents in partnership with a cross-functional team.
• Performs quality checks of documents and data files.
• Performs technical edits and formatting of documents.
• Communicates proactively within the MW team and across other functional areas.
• Supports clinical study execution through expert review of study-level documents.
• Coordinates and leads document submission workflows.
• Works with project management to develop timelines for documents.
• Collaborates with cross-functional team to review study results.
• Contributes scientific knowledge and analytical skills to the production of documents.
• Stays current with respect to key global guidance documents, regulations, or directives.

Requirements

• 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, and regulatory requirements.
• Basic project management skills.
• Initiative and creativity in solving routine problems.
• Attention to detail related to consistency and scientific accuracy.
• Basic computer skills related to word processing and literature searches.
• Knowledge of applicable US and global regulations.
• Excellent verbal and written communication skills.

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!