Sr Medical Director
Integrated Resources Inc
Job Title: Sr Medical Director
Job Location: Alachua, FL
Job Duration: 6 Months (Possibilities of Extension) Job Summary:
Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
1. General Support:
Job Location: Alachua, FL
Job Duration: 6 Months (Possibilities of Extension) Job Summary:
- Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed.
- Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities.
- Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).
Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
1. General Support:
- Ensures tasks delegated to PVG are properly executed.
- Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.
- Adheres to client SOPs/directives and project specific WPDs for assigned projects.
- Adheres to Companies corporate policies and SOPs/WPDs.
- Provides medical consultation to team members and answer all study related medical questions.
- Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
- Provides therapeutic training and protocol training on assigned studies, as requested.
- Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.
- Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
- Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
- Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
- Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.
- Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
- Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.
- MD or equivalent required.
- Active medical licensure preferred.
- Clinical experience in treating patients in the speciality or sub-speciality associated with the applicants training (comparable to 3 years).
- Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 3-5 years) in the industry.
- Direct experience in safety/Pharmacovigilance (comparable to 3 years).
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- Therapeutic expertise across one or more medical specialty or sub-specialties.
- Strong decision-making, problem solving, organizational skills and analytical skills.
- Excellent oral and written communication skills.
- Working knowledge of relevant safety databases (e.g. Medra).
- Flexibility to travel domestically and internationally.
- Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information.
- Proficiency in basic computer applications.
- Fluent in spoken and written English.
- Excellent interpersonal, influencing and team building skills.
- Understanding guidelines (FDA, ICH, EMA and GCP).
- Working knowledge of biostatistics, data management, and clinical operations procedures.
- Ability to act as a mentor/trainer to other staff.
Vacancy posted 2 days ago
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