Associate Director, Medical Writing (Clinical Development)

About the position

Axsome Therapeutics is seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols and clinical study reports. This is a key position within the Clinical Development Group with ample opportunity to make real impact. The medical writer reports to the Head of Clinical Development. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

Responsibilities

• Interprets, analyzes, and synthesizes complex clinical data and develops high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, and other documents in support of Clinical Development programs
• Attends strategic meetings as applicable
• Closely collaborates with, and applies strategic direction from, project leads, and biostatisticians in order to manage and prioritize assignments and ensure deliverables are completed per time and quality goals
• Previous experience with preparation and QC of clinical regulatory documents: Protocols, IBs, CSRs, Module 2 Summary Documents, Clinical Overviews and Agency Briefing Documents
• Develops documents for assigned programs in compliance with company standard operating procedures (SOPs)
• Participate in developing timelines, managing review/approval workflows, and QC/publication readiness
• Leads cross-functional teams to ensure team-wide agreement on documents content
• Oversees outsourced medical writings projects and the associated vendor(s), as applicable
• Ensures compliance and accountability for all regulatory documents prepared by the company.

Requirements

• Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 6 years relevant experience
• A strong working knowledge of pharmaceutical drug development and GxP principles is required
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Nice-to-haves

• Highly knowledgeable in 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 and easily understood documents
• Familiarity with the preparation of Statistical Analysis Plans and document data mapping
• Experience with programmed outputs of tables, figures and listings for analysis and communication of clinical data
• Ability to work collaboratively with and coordinate the efforts of team members to resolve comments and complete deliverables
• Excellent interpersonal skills and judgement that facilitates working with cross-functional executive leadership, and maintaining the security of proprietary information
• Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment
• Flexibility for adapting to rapidly changing deadlines and priorities
• Detail oriented
• Able to self-manage effort to maintain alignment with strategy and corporate goals

Benefits

• The anticipated salary range for this role is $170,000 - $185,000
• Annual bonus
• Significant equity
• Generous benefits package