[Remote] CMLR and Marketing Operations Coordinator at Axsome Therapeutics Inc

United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Bachelor’s degree in life sciences, marketing, communications, or related field
3+ years of experience in US pharmaceutical or biotech industry
Familiarity with FDA promotional guidelines and US regulatory standards
Experience with Veeva Vault PromoMats or similar content management systems
Strong organizational and project management skills
Excellent communication and interpersonal abilities
Ability to work independently and collaboratively across US-based teams
Ability to manage multiple projects simultaneously
Experience supporting US commercial and medical teams
Knowledge of PhRMA Code and OPDP regulations
Prior experience with digital asset management, omnichannel content review, and marketing analytics platforms (e.g., Veeva Vault PromoMats, Salesforce, Adobe)
Experience working in a small but fast-growing, entrepreneurial environment

Responsibilities

Coordinate the end-to-end CMLR review process for promotional and medical materials
Schedule and facilitate CMLR meetings, distribute agendas, and capture decisions and action items
Manage submission timelines and approvals using Veeva Vault PromoMats or similar systems
Ensure version control and compliance with FDA regulations and PTC SOPs
Partner with US-based stakeholders to resolve review issues and ensure timely approvals
Maintain audit-ready documentation and support inspection readiness activities
Track performance metrics and assist in preparing campaign reports and dashboards
Support execution of US marketing campaigns and tactics across digital and print fulfillment channels
Assist in managing marketing calendars, timelines, and deliverables
Coordinate with vendors and agencies for asset development, trafficking, and deployment
Maintain marketing asset libraries and ensure proper tagging, archiving, and versioning
Ensure alignment between marketing execution and CMLR-approved content

Skills

Axsome Therapeutics Inc

Develops therapies for CNS disorders

About Axsome Therapeutics Inc

Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.

New York City, New YorkHeadquarters

2012Year Founded

$430.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Performance Bonus

Company Equity

Risks

Increased competition from companies like Compass Pathways in the CNS market.

Potential delays in AXS-07 launch amid growing market anticipation.

Departure of key personnel like Lori Englebert may impact strategic direction.

Differentiation

Axsome focuses on CNS disorders with limited current treatment options.

AXS-05, an NMDA receptor antagonist, targets major depressive disorder and treatment-resistant depression.

Axsome's balanced portfolio includes both clinical and research stage products.

Upsides

FDA's fast-tracking of CNS treatments could expedite Axsome's drug approvals.

Increased investment in CNS R&D drives innovation, benefiting Axsome's pipeline.

Growing personalized medicine trend offers Axsome opportunities for tailored therapies.

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