Medical Director / Senior Medical Monitor (extensive oncology experience required)

Ergomed • Raleigh, NC

2d

About The Position

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. The Senior Medical Monitor within the ERGOMED Global Medical Affairs is responsible for providing medical monitoring and medical safety expertise to enable high quality and efficiency in the ERGOMED Global Medical Affairs and providing Medical Monitoring tasks including those of higher complexity. Provides leadership to the global medical function including medical monitoring. Collaborates with Global Medical Affairs Leadership on the ongoing development of the Department and contributes to the business plan at both the tactical and strategic levels. Directly and through subordinate staff, ensures the successful management of medical advisory and medical monitoring projects in compliance with federal regulations, ICH Guidelines, Good Clinical Practices (GCPs) and the Company’s Standard Operating Procedures (SOPs). Additionally, this position involves cross-functional communications, strategic planning, and participation in clients’ strategic decision-making, physician review, medical monitoring and critical interactions with scientific advisors. The Medical Director will assist the Head of Medical Affairs in educating, mentoring and developing Ergomed physicians to ensure their competence and confidence in developing their skills to become subject matter experts in medical monitoring. The role requires active monitoring of costs and project deliverables and interaction with the project managers, project directors and the Head of Medical Affairs. Additionally, the role must include the review and implementation of efficiency strategies whilst maintaining the highest quality of work.

Requirements

• Proven, efficient medical communication
• Highly organized, with strong interpersonal, presentational, and documentation skills
• Proven efficiency in timely delivery
• Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills
• In-depth knowledge of medical terminology and of GCP, ICH guidelines relevant to global drug safety and drug development process and regulations
• Good decision-making and problem resolution based on all relevant information.
• Strategic thinking, recognizing key issues and providing practical solutions
• Ability to work effectively in an environment characterized by tight timelines and changing priorities.
• Excellent Leadership skills

Responsibilities

• Provides all levels of medical monitoring activities including patient safety surveillance and integrity.
• Included in multi-cross-functional support to the project team in conducting clinical trials
• Could act as the main point of contact with the sponsor as a medical representative
• Coordination and delivery of trainings, supervision, and oversight of Medical Monitors
• Main point of contact and escalation for Medical Monitors
• Participation in the development and revision of Medical Monitoring SOPs
• Assists with the assignment, transitioning, and assimilation of individuals to work as Medical Advisors, Medical Monitors and Study Physicians on project.
• Interacts with other departments to ensure the required quality of service is provided to a sponsor

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 1,001-5,000 employees