Ophthalmology Medical Monitor/SME (Project-Based) - Remote
- 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
- 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
Recommended Jobs
Scientist/Senior Scientist for Pharmacology
Biocytogen Boston Corp is seeking a highly motivated and versatile Pharmacology Scientist to support both in vivo and in vitro preclinical research services in the fields of immunology, immuno-…
Assistant Manager
Job Description Job Description Overview Drive Success as an Assistant Manager at Our High-Energy Convenience Store! From customer service to operations, are you ready to be the steady han…
Lead Software Engineer: Advanced Design Tools (ADT) Design System Integration Developer and Engineer for NexGen Hot Gas Path Design
Job Description Summary At GE Aerospace, we're inventing the future of flight-lifting people up and bringing them home safely. Whether it's manufacturing components for our GE9X engines, driving i…
Gastroenterology Physician
Job Opportunity: Gastroenterologist (Locums) Location(s): Southborough, Worcester, and Marlborough, Massachusetts Start Date: November 1, 2025 (target; credentialing + days) Coverage Need…
Part Time Staff Accountant
: Why We're Here We believe heartfelt, human connections make people's lives better. Especially the people who work here. Our founder, Bill Kimpton rebelled against impersonal, generic hospi…
Freelance Recruiter - Up To $11,000 Per Placement
Company: RECXCHANGE Job Type: Monthly Salary: $3000 - $11000 per month
CEO Executive Assistant
: Position Summary: Under minimal supervision, the CEO Executive Assistant provides a wide variety of assistance to the President and CEO. Performs duties requiring expert level secretarial and a…
Sales Representative - Fintech
For our external partner company, we are seeking a self-driven Sales Representative with expertise in the fintech industry to play a key role in driving revenue and building lasting client relation…
Sr. Customer Service Representative
Responsibilities for the Senior Customer Service Representative include: daily interaction with internal and external customers, assistance with consumer inquiries and disputes, maintenance of inte…
Facility Attendant (Housekeeping) - Per diem, Day Shift
Facility Attendant - Whittier Rehab Hospital - Bradford Per diem, Day Shift Shifts: 7:00a - 3:30p Pay Rate : $16.00-$18.00 per hour ESSENTIAL: Cleaning of assigned patient rooms an…