Alto Neuroscience is a clinical-stage biopharmaceutical company that integrates the biology of the patient into drug development to improve the lives of people with mental health conditions. Currently, there is no objective way to diagnose psychiatric illness, nor to identify which treatment is best for an individual patient. Treatment selection is presently done by trial-and-error as there are no tests that can inform these decisions. Through our AI-enabled biomarker platform, we combine rich sources of information on patients' brain activity and behavior to rapidly develop highly-effective medicines for targeted populations. We aim to replace today's trial-and-error clinical approach by aligning the right Alto drug with the right patient, redefining psychiatry at a time when the world needs it most. Come join us on our mission to re-imagine and re-engineer the treatment of mental illnesses!
Duties and Responsibilities
May include but not limited to the following:
- Under minimal supervision, writes and edits clinical study reports (CSR), protocols, informed consent forms (ICFs), and other clinical and regulatory documents including Investigator Brochures (IB) and annual reports.
- Assists with establishing and adhering to timelines for all assigned medical writing tasks
- Assists with the preparation of briefing documents, INDs, and other major submissions (BLAs, MAAs) as needed.
- Leads the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts.
- Provides QC support for clinical regulatory documents as needed (cross-checking data and verifying content from source documents).
- Reviews case report forms, statistical analysis plans, and data tables and listings for content and format.
- Participates in clinical project team meetings.
- Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards.
- Assists and/or leads the development of standard operating procedures to cover controlled clinical documentation such as protocols, ICFs, CSRs and IBs.
Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience.
- 3+ years' experience writing/editing clinical regulatory documents including clinical study reports
- Pharmaceutical industry experience and background a plus
- Excellent writing, editing, attention to detail and verbal communication skills
- Ability to critically analyze and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas
- Proficiency in Microsoft Word
- Familiarity with CTD, ICH, GCP and other standards
- Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment