Medical Regulatory Clinician (Geneva or home-based)
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.
Contribute to the successful creation of a submission dossier for the registration of a drug in infectious diseases.
- 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.