Medical Director

Medical Director

INC Research

Europe

A summary of duties you will be involved in as Medical Director

  • Manages subject safety and the scientific integrity of clinical trials;
  • Responsible for subject-safety and the scientific integrity of clinical trials;
  • Performs the duties of a Medical Monitor;
  • Provides 24-hour coverage for clinical trials;
  • Participates in bids, bid-defenses & feasibility assessments when requested;
  • Provides project-specific and therapeutic training to sponsors and Company staff as needed;
  • Works with the Drug Safety Department by providing medical input and oversight;
  • Works with Medical Writing/Regulatory in the preparation of a variety of documents as required;
  • Maintains in-depth knowledge of worldwide drug development regulations and Good Clinical Practice (GCP) guidelines;
  • Interacts with senior management, project management, and other departments as appropriate;
  • Provides clinical development and regulatory consulting advice both within Company and to clients as requested;
  • Locates and interacts with outside experts as necessary;
  • Provides feedback to management on quality issues within the clinical trial team;
  • Represents Company at scientific meetings as required;
  • Primary senior-level contact for customers;
  • Assumes line-management duties as needed.

Qualifications

To succeed in this role you will need the following skills/experience:

  • A doctoral-level degree in medicine and must have practiced medicine and have clinical research experience;
  • In-depth knowledge of FDA and worldwide drug-development regulations. Strong understanding of the use of medical terminology and of drug-names in multiple nations, cultures and environments;
  • In-depth knowledge of national and ICH Good Clinical Practice (GCP) guidelines;
  • Experience working in matrix-teams;
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment;
  • Skilled at presenting data to groups, and in the creation of effective documentary communication.

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INC Research     Multiple Countries     Clinical Research     Manager and Executive     Medical     Quality Assurance     Regulatory Affairs     5 Years+ Experience    

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