Axsome Therapeutics Inc

Contract, US Medical Information and Review Specialist

United States

Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
BiopharmaceuticalIndustries

Requirements

Candidates must possess a Bachelor's degree in pharmacy or a scientific discipline, coupled with a minimum of 3 years of experience in medical information and medical review within the pharmaceutical industry. Required skills include in-depth knowledge of pharmaceutical industry codes and legislation relevant to medical information, expertise in drug information communication and management, and extensive knowledge of information retrieval, dissemination processes, medical information systems, and databases. Proficiency in Microsoft Office, excellent verbal and written communication skills, the ability to work independently and collaboratively in a fast-paced, matrixed team environment, strong analytical and problem-solving skills, and excellent planning, organization, and time management skills are also essential. An advanced degree (PharmD, PhD, Masters) is preferred.

Responsibilities

The Contractor, Medical Information and Review Specialist will provide second-line expertise for inquiries escalated from the medical information call center, conduct literature searches, and write custom responses. They will contribute to inquiry metric reports, generate standard response and FAQ documents, and suggest process improvements. Responsibilities also include reviewing commercial and medical materials for scientific and medical accuracy, ensuring adherence to regulatory requirements and SOPs, and interpreting medical literature for compliant communication. The role involves identifying potential business risks, attending medical congresses to answer questions, staying updated on industry developments, providing medical/scientific alerts, participating in meetings to promote medical information services, and contributing to allocated medical services projects.

Skills

Medical Information
Literature Search
Medical Review
Regulatory Compliance
Standard Operating Procedures (SOPs)
Biopharmaceutical
Medical Writing
Claim Substantiation
Data Robustness
Fair Balance

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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