Medical Advisor
9 hours ago
**Job Overview - Expressions of Interest**
As product and therapy area expert, the Medical Advisor exists to provide
non-promotional, medical support that helps to ensure the safe and effective use of products. The Medical Advisor achieves this through effective scientific interactions with external stakeholders, support for physicians wishing to
conduct investigator sponsored studies and/or participate in relevant
compassionate use programmes, and by providing medical and scientific
support for internal stakeholders.
The Medical Advisor ensures that they are at all times aware of the latest
medical, regulatory and scientific insights through appropriate scientific
exchange with external experts, attendance at key scientific meetings, literature review, and participation in internal cross-functional teams.
In addition, the Medical Advisor develops and implements medical strategic and operational plans in the designated therapy area and is the primary internal medical/scientific training resource. Finally, they are a principal Medical contact for external stakeholders such as physicians, pharmacists and patient organisations.
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 hours per day, 7 days per week to respond to urgent protocol
related issues at the investigative sites.
**Qualifications**
- Other Medical degree from an accredited and internationally recognized
medical school with a curriculum relevant to general medical education Req
- Other Specialty Board certification in relevant specialty area preferred Req
- 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 Req
- 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 coworkers, managers and clients
- Attention to details, flexibility and ability to provide advice on multiple assignments
- Current and valid country/state medical license or equivalent, from the country or region in which he/she resides and works Req
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