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hace 2 semanas
Job Overview
We are seeking a highly skilled and experienced Senior Psychiatrist to join our team as a Medical Director - Global Advisor. In this role, you will provide medical expertise to all divisions of the company, providing guidance on clinical and scientific aspects of assigned projects.
Key Responsibilities:
- Serves as Global and Regional Medical Advisor on assigned projects.
- Provides medical support to investigative sites and project staff for protocol-related issues.
- Performs medical review of protocols, Investigative Drug Brochures (IDBs), and Case Report Forms (CRFs).
- Attends and presents at Investigator Meetings.
- Reviews and clarifies trial-related Adverse Events (AEs).
- Collaborates with Pharmacovigilance department for medical case review of Serious Adverse Events (SAEs) and Analysis of Similar Events (AOSE).
- Reviews adverse event coding and Clinical Study Reports (CSRs).
Requirements:
- Excellent communication, presentation, and interpersonal skills.
- Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
- Certification as a Psychiatrist (mandatory).
- 3-5 years of prior relevant experience in general clinical medicine.
- Previous clinical research experience as an investigator or in the Pharma, CRO, or Biotech industry is required.
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
- Strong Business Acumen.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.