Medical Science Advisor

vor 4 Wochen

Zug, Zug, Schweiz PSI Vollzeit

Job Title: Medical Science Advisor

At PSI, we are seeking a Medical Science Advisor to provide medical input to global clinical studies and advise our teams and business partners on medical matters.

Responsibilities:

  • Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies, and third-party vendors on medical matters.
  • Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations.
  • Review and analysis of clinical data to ensure the safety of study participants in clinical studies.
  • Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments.
  • Address safety issues across the study from sites and the study team.
  • Review listings for coded events to verify Medical Dictionary for Regulatory activities.
  • Participate in bid defense meetings.
  • Assist in Pharmacovigilance activities.
  • Identify Program risks, and create and implement mitigation strategies with Clinical Operations.
  • Ability to organize and lead clinical development advisory boards and safety monitoring boards.
  • Ensure Study team compliance with FDA, EMEA, ICH, and GCP guidelines.
  • Review and sign off clinical documents with respect to medical relevance.

Qualifications:

  • Medical Doctor degree required.
  • Canada Board Certification in Gastroenterology required.
  • Experience as a practicing Gastroenterology (minimum of 10 years).
  • Full working proficiency in English.
  • Clinical Research experience preferred.
  • Proficiency with MS Office applications.
  • Communication, presentation, and analytical skills.
  • Problem-solving, team, and detail-oriented.

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