Head of Medical Writing

Alto Neuroscience•Mountain View, CA

4d•$170,000 - $190,000•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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 companys pipeline
Prior experience scaling medical writing operations

Responsibilities

Serve as lead author for key clinical, regulatory, and scientific documents, including but not limited to: Clinical Study Protocols and Amendments Investigators 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
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
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