PRIMARY ROLE

The Head of Medical Writing is a senior, hands-on leader responsible for the strategic direction, execution, and quality of all medical and regulatory writing activities across the company. This role combines deep individual contribution with oversight and management of contract medical writers and vendors. The ideal candidate is a seasoned medical writer who thrives in lean biotech environments, is comfortable owning critical documents end-to-end, and can scale writing operations as the pipeline grows.

WHAT YOU'LL DO

Medical & Regulatory Writing (Primary Responsibility)

• Serve as lead author for key clinical, regulatory, and scientific documents, including but not limited to:
  • Clinical Study Protocols and Amendments
  • Investigator’s Brochures (IBs)
  • Clinical Study Reports (CSRs)
  • IND/CTA modules and summaries
  • Briefing documents for regulatory interactions (FDA, EMA, etc.)
  • Development Safety Update Reports (DSURs)
  • Manuscripts, abstracts, and scientific publications as needed
• Translate complex clinical, statistical, and regulatory information into clear, accurate, and compliant documents
• Ensure consistency of scientific messaging and data interpretation across documents and programs
• Partner closely with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, and Safety to drive document development

Leadership & Oversight

• Build, manage, and mentor a network of contract medical writers and vendors
• Provide clear scopes of work, timelines, templates, and expectations for outsourced writing
• Review, edit, and quality-control deliverables from external writers to ensure scientific accuracy, clarity, and regulatory compliance
• Act as the final quality owner for all medical writing outputs
• Identify opportunities to improve efficiency, quality, and scalability of medical writing processes

Strategy & Process Development

• Define and maintain medical writing standards, templates, style guides, and SOPs
• Develop document timelines aligned with clinical and regulatory milestones
• Contribute to regulatory and clinical development strategy from a writing and content perspective
• Support inspection readiness and respond to regulatory questions related to written submissions

LOCATION

On-site - Mountain View, CA

SALARY RANGE

$170K-$190K

*depending on qualifications and experience level

QUALIFICATIONS

Required Skills

• Advanced degree in a scientific or medical discipline (PhD, MD, PharmD, or MS with extensive experience)
• 10+ years of medical writing experience in biotech, pharma, or CRO settings
• Proven experience as lead author for major regulatory documents
• (eg, INDs, CSRs, IBs)
• Ability to manage and review contract medical writers
• Strong understanding of ICH guidelines, GCP, and global regulatory requirements
• Exceptional writing, editing, and organizational skills
• Ability to work independently in a fast-paced, resource-lean biotech environment

PREFERRED SKILLS

• Experience in early-stage to mid-stage biotech companies
• Experience supporting regulatory agency interactions (FDA, EMA)
• Publication strategy and manuscript development experience
• Therapeutic area expertise relevant to the company’s pipeline
• Prior experience scaling medical writing operations

WHY ALTO

At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics.

Alto Neuroscience is an equal-opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.

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