Role Description
The Medical Advisor is a medical expert with general or specialized experience in clinical medicine. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts, and serve as a medical monitor for contracted projects. As appropriate, they may support Medical Directors.
Key Accountabilities
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Project Execution: Medical Monitoring Delivery & PV Support:
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With guidance, deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor.
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Participate actively in study planning with feasibility leaders and solution consultants.
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Participate in team project and investigator meetings.
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Provide training of study teams on TA indication and protocol (does not include any direct medical advice on patient care or management).
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Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study.
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Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc.
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Deliver medical monitoring activities according to MMP during the study conduct.
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Answer to site/study team questions relating to the study conduct or protocol.
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Review and sign off all data listings/tables, protocol deviations, datasets for medical accuracy/consistency.
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Deliver medical support to the project in close coordination with the Project Leader.
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Timely identifying risks and challenges, pro-actively proposing and/or delivering relevant actions contributing to the success of the study/project.
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Creating a sense of urgency on any matters pertaining to safety of study participants and scientific integrity of the study.
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Attend and support any audits or inspections pertaining to assigned studies.
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Participate in periodic rotas including night and weekend shifts for emergency medical contact.
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Provide medical input into PV workflows and projects and participate in safety processing for studies.
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Support regulatory safety reporting activities.
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Client Relationship Building & Engagement:
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Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities.
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Follow up satisfaction metrics pertaining to medical activities in assigned studies and propose/execution remediation plan in case of client dissatisfaction.
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Business Development:
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Support Business Development, balancing time devoted to this activity with billable tasks.
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Provide medical expertise/leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings.
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Provide support for marketing activities as requested.
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Share sponsor insights and experiences with peer and proposal teams.
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Medical Expertise:
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Provide medical expertise to clients across multiple channels and interactions.
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Input into protocol development.
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Medical review of various documents, which might be audited by clients and regulatory agencies.
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Provide medical expertise and training to other Parexel colleagues.
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Write clear, concise medical documents as appropriate.
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Participate in activities to raise, coordinate and promote Parexel medical expertise.
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Attend preparation and Bid pursuit meetings as appropriate.
Qualifications
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Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts.
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Client-focused approach to work.
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Excellent time management skills.
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Excellent verbal and written medical communication skills.
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Excellent standard of written and spoken English.
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A flexible attitude with respect to work assignments and new learning.
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Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
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Willingness to work in a matrix environment and to value the importance of teamwork.
Requirements
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Experience in clinical medicine (general or specialist qualifications) with a specialty in a therapeutic area.
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Clinical practice experience.
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A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred.
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Basic knowledge of the drug development process including drug safety.
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Experience in Pharmaceutical Medicine, preferred.
Education
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Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicine (residency, internship).