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, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs 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. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This 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. We are unable to consider candidates who are looking for fully remote roles.  

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

• 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 / Qualifications  

• 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. We are unable to consider candidates who are looking for fully remote roles 

 Experience, Knowledge and Skills  

• Must be able to efficiently manage multiple projects.  

• Computer proficiency, knowledge of GCP and ICH guidelines and other industry regulations preferred 

• Must have good organizational skills, be a team player, function independently, and be able to interact comfortably with colleagues and external stakeholders 

• Comfortable multi-tasking in a fast-paced small company environment and able to adjust priorities as needed 

Salary & Benefits 

The anticipated salary range for this role is $60,000 - $70,000. 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. 

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, 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 Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.