Medical Advisor- Rheumatology

Job Overview

Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects. Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications inclusion/exclusion determinations and issues of patient safety and/or eligibility.

Essential Functions

• Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects.

• Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications inclusion/exclusion determinations and issues of patient safety and/or eligibility.

• May contribute to the medical review of the protocol Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).

• May provide therapeutic area/indication training for the project clinical team.

• Attends and may present at Investigator Meetings.

• Performs review and clarification of trial-related Adverse Events (AEs).

• May perform medical case review of Serious Adverse Events (SAEs) including review of case documentation and patient narrative in collaboration with the Pharmacovigilance department.

• May provide medical support for the Analysis of Similar Events (AOSE) in collaboration with or on behalf of Pharmacovigilance department.

• May perform medical review of adverse event coding.

• Performs review of the Clinical Study Report (CSR) and patient narratives.

• Attends Kick-Off meetings weekly team meetings and client meetings as needed or requested.

• Available 24/7 to respond urgent protocol -related questions from investigative sites in accordance with local labor laws.

Qualifications

• Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.

• Board Certified.

• Typically requires 3 - 5 years of prior relevant experience in general clinical medicine including experience in the requested applicable medical specialty area or equivalent combination of education training and experience.

• Current knowledge of medical scientific and clinical landscape in applicable therapeutic area.

• Good communication presentation and interpersonal skills including good command of English language (both written and spoken).

• Ability to establish and maintain effective working relationships with co-workers managers and clients.

• Attention to details flexibility and ability to provide advice on multiple assignments.

• Current or prior license to practice medicine.

• Clinical experience in the requested medical specialty.

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