Medical Regulatory Clinician (Geneva or home-based)

Reference Number: 896351-W
Type of placement: Contract, 12 months
Location: CH, Romandie

Introduction:

Our client is a well-established non-profit drug research and development organisation who partners with private industry, public institutions, academia and NGOs to advance new treatments in disease-endemic countries.

With a remarkable achievement of bringing 8 new treatments to the market, the organisation also benefits from a rich pipeline of new potential drugs, which are being investigated through their numerous affiliates worldwide.

For their office in Geneva, we are looking for a Medical Regulatory Clinician for an initial 12-month contract.

Purpose:

Contribute to the successful creation of a submission dossier for the registration of a drug in infectious diseases.

Main Responsibilities:

  • Provide expert support for the review and finalization of the clinical overview (module 2.5) and clinical summaries (module 2.7) of the drug’s registration dossier;
  • Collect and review all the necessary documentation and clinical data to enable the creation of the submission dossier;
  • Provide input as required into labelling and risk management plan activities;
  • Contribute to review of clinical study reports;
  • Collaborate with cross-functional teams;
  • Provide other clinical / medical support as needed.

Qualifications and Experience:

  • MD (preferred) or higher scientific degree (PhD, PharmD);
  • At least 5 years of experience in Clinical Research;
  • Good knowledge of regulatory requirements for drug registration internationally;
  • Previous experience interacting with Health Authorities;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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