Medical Writer, Clinical Development

Overview

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and developing differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes.

We are seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols and clinical study reports. This key position is within the Clinical Development Group and offers ample opportunity to make real impact.

Based at Axsome’s HQ in New York City. The role requires onsite presence at least three days per week (Monday, Tuesday, Thursday). Remote candidates will not be considered.

• Interpret, analyze, and synthesize complex clinical data to develop high quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, and other support documents for Clinical Development programs.
• Attend strategic meetings as applicable.
• Collaborate closely with project leads and biostatisticians to manage and prioritize assignments, ensuring timely and high‑quality deliverables.
• Develop documents in compliance with company SOPs.
• Participate in developing timelines, managing review/approval workflows, and QC/publication readiness.
• Lead cross‑functional teams to ensure agreement on document content.
• Oversee outsourced medical writing projects and associated vendors where 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 6 years of relevant experience.
• Previous experience preparing and QC’ing clinical regulatory documents:
  Protocols, IBs, CSRs, Module 2 Summary Documents, Clinical Overviews, and Agency Briefing Documents.
• Strong knowledge of pharmaceutical drug development and GxP principles.
• Ability to work onsite Monday, Tuesday & Thursday. Remote work is not acceptable.

• 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 preparing Statistical Analysis Plans and data mapping.
• Experience with programmed outputs of tables, figures and listings for analysis and communication of clinical data.
• Strong collaborative skills to coordinate effort among team members and resolve comments efficiently.
• Excellent interpersonal skills and judgment to work with cross‑functional executive leadership while maintaining data security.
• Ability to manage/prioritize multiple projects under general supervision in a fast‑paced environment.
• Adaptability to rapidly changing deadlines and priorities.
• Exceptional attention to detail.
• Ability to self‑manage effort to stay aligned with strategy and corporate goals.

The anticipated salary range for this role is $140,000 - $175,000 per year. Salary offers will be based on experience, qualifications, internal equity and location. Axsome offers a competitive employment package including 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. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, 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 Therapeutics does not accept unsolicited resumes from recruiters or third‑party recruitment agencies and will not pay placement fees for unsolicited candidates. Only approved vendors explicitly invited to support a specific search may access our Applicant Tracking System.