Associate Director/Director, Medical Writing (Clinical Development)

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role:

Axsome Therapeutics is seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols, clinical study reports, manuscripts, conference abstracts, and posters. This is a key position within CNS scientific communication with ample opportunity to make real impact. The medical writer reports to the Head of Clinical Development, with a dashed dotted line to the Medical Affairs/HEOR lead as applicable.

This role is based at Axsome's NYC HQ. 

Job Responsibilities and Duties include, but are not limited to, the following:

• Interpret complex data and develops high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, publications and other documents in support of Medical Affairs, RWE/HEOR and/or Clinical Development programs   
• Attends strategic meetings as applicable
• Closely collaborates with, and apply applies strategic direction from, project and publication leads, and biostatisticians in order to manage and prioritize assignments to ensure deliverables are completed per time and quality goals
• Previous experience with preparation and QC of various document types: core clinical documents (protocols, IBs, CSRs, etc.), Health Authority Submission documents (Agency Briefing Documents, eCTD Summary Documents, Orphan Drug Applications), etc is a plus
• Develops documents for assigned programs in compliance with company standard operating procedures (SOPs). (Previous experience with preparation and QC of various document types: core clinical documents (protocols, IBs, CSRs, etc.), Health Authority Submission documents (Agency Briefing Documents, eCTD Summary Documents, Orphan Drug Applications), etc is a plus)
• Develops documents for assigned programs in compliance with company standard operating procedures (SOPs)
  •    This may include developing timelines, review/approval workflow management, and/or QC/publication readiness
• Works with cross-functional internal teams to ensure wide acceptability of documents and consensus of content
• Oversees outsourced medical writings projects and the associated vendor(s), as applicable
• Critically analyzes, synthesizes, and presents complex information
• Drives Results
• Ensures Accountability

Requirements / Qualifications

• Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 5-8 years relevant experience
• A strong current working knowledge of the pharmaceutical environment is required
• Must be able to work on-site Monday, Tuesday and Thursday

Experience and Knowledge:

• Highly knowledgeable in the relevant disease areas
• Track record of developing high-quality scientific documents
• Ability to interpret, evaluate, and communicate (in a variety of formats and styles) complex scientific and clinical data
• Expertise in use of online and other data sources for literature searches and information
• General knowledge of the drug development and approval processes and GXP principles
• Ability to work with cross-functional executive leadership and exposure to sensitive information, necessitating considerable use of tact, diplomacy, discretion, and judgment
• Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables
• Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment
• Flexible and able to adapt to changing deadlines and priorities
• Excellent written, verbal, and interpersonal communication skills
• Highly attentive to detail
• Able to self-manage effort to maintain alignment with strategy and corporate goals

Salary and Benefits:

The anticipated salary range for this role is $170,000 - $185,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.