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This role is a project-based consulting opportunity to conduct medical monitoring on an as-needed basis. This is not a full-time position.

Roles & Responsibilities

• Responsible for medical monitoring tasks, which may include:
  • Eligibility review
  • Review of safety-related protocol‑related deviations
  • Review of safety data
  • Develop Medical Monitor Plan
  • Participation in medical monitoring and/or safety review meetings as needed
  • Medical management of queries
  • Medical coding review
  • Maintain records and logs
  • Medical review of study documents
• Provide medical input throughout the development process
• Provide medical input into the development and execution of study documents and plans, such as study protocol, IB, SMP, DMP, SAP, Lab manuals, etc.
• Provide significant expertise as primary medical reviewer of individual adverse event reports, clinical, and safety documents
• Lead safety activities on assigned product(s) that may include interactions with other functional groups inthecompany
• Responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations
• Responsible for strategies in monitoring and analysis of cumulative safety information
• Maintains significant knowledge of global and local regulations and guidance as they pertain to medical review and safety reporting

• Medical degree required (MD or equivalent)
• Specialty in Neurology or comparable experience in Neurology
• 5 or more yearsof clinical experience and/ or research experience required
• Relevant experience in medical monitoring and/or medical reviewer in pharmaceutical industry
• Excellent scientific writing skills
• Ability to understand clinical data
• Proficiency with MS Office applications
• Good communication skills
• Strong knowledge of current regulatory practices and domestic and international regulations