Medical Director

Medical Director

Syneos Health

Home Based, Poland

Summary:

Interacts with senior management, customers, and project teams to ensure the safety of subjects in clinical trials; ensures the scientific integrity of the clinical portions of clinical trials; provides medical input to clinical programs; provides clinical development and regulatory consulting advice as needed. Performs the duties of a Medical Monitor.

Essential Functions:

  • 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.

Requirements:

  • 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;
  • Computer and word-processing skills, including the use of spreadsheets, e-mails and smart-phones;
  • Experience working in matrix-teams;
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment;
  • Effective organizational and interpersonal skills;
  • Skilled at presenting data to groups, and in the creation of effective documentary communication;
  • Customer-focused with a disciplined approach to work with excellent verbal communication and language skills;
  • Fluency in written and spoken English.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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