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

About PTC Therapeutics

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Job Description Summary

As a member of the global medical services function, the Contractor, Medical Information and Review Specialist, provides a premium medical information service to support internal and external customers in North America. They will also review commercial and medical materials for scientific and medical accuracy, working cross-functionally with internal colleagues. They will support adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Essential Functions

Primary Duties/Responsibilities:

  • Provides second-line expertise for inquiries escalated from the medical information call center.
  • Conducts literature searches in response to unique medical inquiries and writes custom responses as needed.
  • Contributes towards inquiry metric reports for specified reporting period; highlighting trends and identifying needs and solutions as appropriate to help meet inquirer needs.
  • Ensures accuracy of reported information.
  • Generates enquiry “standard response” and “frequently asked questions” documents, incorporating local preferences when needed, whilst ensuring the core consistency of responses.
  • Suggests improvements to processes, systems and tools for sharing knowledge within medical services, and throughout the organization.
  • Member of medical and promotional review teams responsible for the review of claim substantiation; references for medical accuracy; data robustness; fair balance and scientific rigor.
  • Interprets medical literature to assist in the production of effective and compliant communication and promotional messages.
  • Identifies and informs management of any issues that may jeopardize PTC’s products or business.
  • Attends medical and scientific congresses and answering questions at medical booths.
  • Keeps abreast of developments (e.g. local legislation and regulations), new technology and the competitive environment.
  • Provides medical/scientific alerts to internal colleagues in a timely manner, following business or development relevant publications.
  • Participates in meetings to increase awareness of medical information services and available information.
  • Contributes to specific allocated medical services projects.

Knowledge/Skills/Abilities Required

Minimum Level of Education and Years of Relevant Work Experience:

  • Bachelor’s degree in pharmacy or scientific discipline.
  • Minimum of 3 years’ experience of medical information and medical review in the pharmaceutical industry.

Special Knowledge or Skills Needed and/or Licenses or Certificates Required:

  • In-depth working knowledge of relevant pharmaceutical industry codes and legislation relevant to medical information.
  • Demonstrated expertise in drug information communication and management.
  • Extensive knowledge of information retrieval and dissemination processes and medical information systems and databases.
  • Proficiency with Microsoft Office.
  • Excellent verbal and written communication skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills, including the ability to support and prioritize multiple projects.

Special Knowledge or Skills and/or Licenses or Certificates Preferred:

  • Advanced degree (Pharm D, PhD, Masters).

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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