Associate, TMF Documentation

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 develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish.

About the Role

Axsome Therapeutics is seeking an Associate, TMF Documentation who is responsible for supporting clinical document filing and management of Trial Master Files (TMFs). This role helps ensure TMFs are current and inspection-ready for internal and external entities. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week.

Responsibilities

• Work closely with the Clinical Study Team to assist in the review and maintenance of study-specific TMFs in accordance with Standard Operating Procedures (SOPs) and regulatory guidelines
• Collect, review and index essential documents in accordance with the TMF Structure
• Assist with the maintenance of TMF study trackers
• Provide updates at team meetings of relevant TMF findings and document status as needed
• Ensure TMFs are always inspection-ready
• Assist in preparation for and participates in internal or external audits/inspections
• Demonstrate technical and strategic knowledge of applicable regulatory requirements, including applicable specifications, SOPs and ICH/GCP guidelines
• Maintain knowledge of current industry best practices

Requirements

• Bachelor’s degree required. Preference to candidates with a life science or nursing degree
• Minimum 6 months - 1 year of relevant experience
• Experience with electronic trial master file system(s) including uploading, reviewing, QC, and approval of study required documents preferred
• Knowledge of TMF Reference Model preferred
• Excellent written and oral communication skills
• Ability to work on site Monday, Tuesday & Thursday

Pay

The anticipated salary range for this role is $60,000 - $70,000. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location.

Benefits

Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.