Medical Writer, Clinical Development

About this Role

Axsome Therapeutics is seeking a highly collaborative Medical Writer in New York City to draft, edit, and submit high‑quality, medically accurate documents including protocols, amendments, agency briefing books, and clinical study reports. This key position within the Clinical Development Group offers ample opportunity to make real impact.

This is an on‑site position that requires a presence at least three days per week. Candidates seeking fully remote work will not be considered.

• Interpret, analyze, and synthesize complex clinical data and develop high‑quality strategic scientific documents—including protocols, amendments, agency briefing books, clinical study reports, and other documents—in support of Clinical Development programs.
• Attend strategic meetings as applicable.
• Collaborate closely with project leads and biostatisticians to manage priorities and ensure deliverables are completed on time and to quality standards.
• Develop documents for assigned programs in compliance with company standard operating procedures.
• Participate in developing timelines, managing review/approval workflows, and ensuring QC/publication readiness.
• Lead cross‑functional teams to achieve agreement on document content.
• Oversee outsourced medical writing projects and associated vendors, as applicable.
• Ensure compliance and accountability for all regulatory documents prepared by the company.

• Advanced scientific or clinical degree (MD, PhD, or Pharm
  
  D) and a minimum of six years of relevant experience.
• Previous experience preparing and QC‑reviewing clinical regulatory documents such as protocols, IBs, CSRs, Module 2 summary documents, clinical overviews, and agency briefing documents.
• Strong working knowledge of pharmaceutical drug development and GxP principles.
• Ability to work on site Monday, Tuesday and Thursday; remote work is not an option.

• High knowledge of psychiatric and/or neurological disease areas is a plus.
• Track record of developing high‑quality scientific documents.
• Ability to interpret, analyze, and synthesize complex clinical data into compelling, easily understood documents.
• Familiarity with the preparation of Statistical Analysis Plans and data‑mapping documents.
• Experience with programmed outputs of tables, figures, and listings for analysis and communication of clinical data.
• Ability to collaborate and coordinate with team members to resolve comments and complete deliverables.
• Excellent interpersonal skills and judgment that facilitate working with cross‑functional executive leadership while maintaining the security of proprietary information.
• Ability to manage and prioritize multiple projects under general supervision in a fast‑paced environment.
• Flexibility to adapt rapidly to changing deadlines and priorities.
• Extremely detail oriented; able to self‑manage effort to align with strategy and corporate goals.

The anticipated salary range for this role is $140,000 – $175,000. Axsome offers a competitive employment package that includes an annual bonus, significant equity, and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. Axsome welcomes applicants of all qualified individuals regardless of race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Axsome does not accept unsolicited resumes from recruiters or third‑party agencies and will not pay placement fees for unsolicited applications. Only approved vendors who have been explicitly invited to support a specific search will receive access to our Applicant Tracking System.