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Associate, TMF Documentation at Axsome Therapeutics - ApplyBlast

Associate, TMF Documentation

Axsome Therapeutics

2 months ago

3.1 on Glassdoor

New York, New York, United States

Hybrid

Full Time

Junior

0 applicants

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About this role

The Associate, TMF Documentation supports clinical document filing and management of Trial Master Files (TMFs) at Axsome Therapeutics' New York headquarters. The role ensures TMFs are current, inspection‑ready, and aligned with SOPs and regulatory guidelines, working closely with the Clinical Study Team.

Responsibilities

Review and maintain study-specific TMFs according to SOPs and regulations
Collect, review, and index essential documents following the TMF structure
Ensure TMFs are inspection‑ready and support audit/inspection activities

Skills

Qualifications

Bachelor's degree

About Axsome Therapeutics

axsome.com

Headquarters

New York, New York, United States

Company Size

201-500 employees

Founded

2012

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Axsome Therapeutics is a biopharmaceutical company focused on developing novel therapies for central nervous system (CNS) conditions that have limited treatment options. Its pipeline and commercial programs include candidates such as AXS-05, AXS-12 and AXS-14, addressing disorders including major depressive disorder, Alzheimer’s disease agitation, migraine, narcolepsy and fibromyalgia. Axsome emphasizes innovative mechanisms of action and rigorous clinical development to deliver meaningful improvements in patient outcomes. The company is headquartered in New York City and advances programs through regulatory engagement and commercialization efforts.