[Hiring] Ophthalmology Medical Monitor/SME @MMS

Role Description

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

• 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 medical expertise to sponsors in the drug development process.
• 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 in the company.
• 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
• 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.

Qualifications

• Medical degree required (MD or equivalent)
• Specialty in Ophthalmology or comparable experience in Ophthalmology
• 5 or more years of clinical experience and/or research experience required
• Relevant experience in safety physician, safety committee membership, 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