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About the Role

Axsome Therapeutics is seeking an Associate, TMF Documentation to support clinical document filing and management of Trial Master Files (TMFs), ensuring they are current and inspection-ready.

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, with a preference for 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.

Skills

• TMF Documentation
• Clinical Document Filing
• Trial Master Files (TMFs)
• Standard Operating Procedures (SOPs)
• Regulatory Guidelines
• TMF Structure
• TMF Study Trackers
• ICH/GCP guidelines
• Electronic Trial Master File System
• TMF Reference Model
• Written Communication
• Oral Communication

Location

• New York City

Work Type

• On-site (at least three days per week)

Experience Level

• Associate
• 6 months - 1 year relevant experience

Education Level

• Bachelor's degree

Salary/Compensations

• $60,000 - $70,000

Benefits

• Annual bonus
• Significant equity
• Generous benefits package

About the Company

• Axsome Therapeutics is a biopharmaceutical company focused on treating 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.
• For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

Equal Opportunity

• 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.