Role Description

The Medical Officer has functional responsibility for medical monitoring of clinical trials, medical reviewing of activities and for broad spectrum of internal and external medical consulting, including, but not limited to, advising related to protocol development, preparation of medical strategy for feasibility studies, involvement in bid preparation and bid defense meetings, delivery of medical trainings for relevant stakeholders, professional engagement with external clinical experts, etc.

• Works directly with the Head of Pharmacovigilance and Medical Monitoring, managing both corporate and project related activities.
• Functions as a Medical Monitor leading clinical trial monitoring of safety and efficacy data for assigned protocols.
• Provides safety oversight throughout the lifecycle of the clinical study.
• Cooperates with Safety Monitors to implement safety management activities.
• Evaluates adverse events, serious adverse events (SAE), and other protocol defined safety events.
• Reviews IND/IDE safety reports, CIOMS safety reports, and other aggregate reports.
• Reviews and approves Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug coding.
• Reviews FDA MedWatch Alerts and recommends action for implementation by study teams.
• Provides medical input during development of protocol and associated documents.
• Advises study sponsor and study team on protocol development and design.
• Ensures the medical and scientific quality of safety sections of various documents.
• Develops appropriate study documents and project plans.
• Supports preparation of safety sections of clinical trial reports.
• Engages with safety oversight committees and consults with sponsors and investigators.
• Participates in safety oversight committee meetings and answers questions about safety monitoring.
• Reviews SOC Charter, safety reports, and meeting minutes.
• Participates in sponsor meetings and investigator training meetings.
• Interacts with pharmaceutical companies and other study partners.
• Cooperates with business development teams as medical expert.
• Acts as the internal medical consultant in broad spectrum of activities.
• Provides medical consultancy services as contracted with the client.
• Participates in corporate process improvement and quality assurance activities.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Medical Doctor MD, MBBS, MBBCh, or other equivalent degree.
• 2 years of working experience, preferably a combination of clinical practice and experience in pharmaceutical medicine.
• Demonstrated clinical medicine expertise through practice experience preferred.
• Excellent clinical judgement and ability to communicate complex clinical issues.
• Experience working with regulatory submissions.
• Expertise in safety and medical monitoring and serious adverse event reporting preferred.
• Demonstrated experience with or training in clinical trial data collection.
• Ability to work as a team member and function on a cross functional team.
• Capacity to provide leadership and creativity in the work environment.
• Excellent verbal and written communication skills.
• Fluent in English.
• May travel between corporate locations, offices of relevant regulatory authorities, and Client offices as needed.

Benefits

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment