Ophthalmology Medical Monitor/SME (Project-Based) - Remote

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

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

Role & Responsibilities

• 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

Job Requirements

• 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