About ICH

ICH is an international non-profit Association under Swiss law dedicated to promoting public health through worldwide harmonization to ensure that safe, effective, and high-quality medicines are developed, registered and maintained in the most resource-efficient manner. Harmonisation of technical and scientific requirements is achieved through the development of ICH Guidelines that are implemented by the regulatory authorities that are Members of ICH. Since its inception in 1990, ICH has gradually evolved to respond to the increasingly global face of pharmaceutical development and comprises currently 23 Members and 41 Observers from around the globe, and over 30 technical Working Groups (WGs). MedDRA is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans. It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale.

The MedDRA Steering Committee (SC) is the body responsible for overseeing MedDRA activities, including the Maintenance and Support Services Organisation (MSSO) operations and reports directly to the ICH Management Committee.

Position Summary

Playing a key role in supporting the MedDRA Manager to ensure seamless support for the activities of the MedDRA Steering Committee (SC), the Project Coordinator will take on increased responsibility by leading specific projects, focusing on meetings coordination, documentation management, and collaborating with third-parties.

Key responsibilities

• Support for MedDRA Steering Committee activities & MSSO Oversight Support:
- Support the implementation of the decisions made by the MedDRA SC.
- Contribute to the oversight of the MSSO, ensuring compliance with MedDRA SC decisions and adherence to ICH contractual requirements.
- Take the lead in managing MedDRA SC membership and related processes

• Meetings Coordination in partnership with the Meetings & Project Manager:
- Take the lead in organizing MedDRA SC meetings (both face-to-face and virtual), identifying and scheduling appropriate dates.
- Take notes, prepare and present documents.
- Monitor and report participant attendance during MedDRA SC meetings.

• Documentation Management and Digital Tools Management:
- Ensure proper organization of MedDRA-related files by maintaining a consistent file-naming convention and folder structure, particularly in relation to MedDRA SC meetings.
- Support the integration of digital tools and contribute to the development of a communication strategy for MedDRA activities.

• Support for ICH Collaborations and outreach activities:
- Provide coordination and assistance with ICH collaborations involving third parties, as well as outreach activities.

Candidate Profile

• Bachelor degree in Business Administration, International Affairs, Public Health or Public Policy
• 3-5 years’ proven experience in project coordination and process improvement
• Well organised with ability to effectively plan & coordinate multiple parallel activities
• Fluency in English (both written and oral), proficiency in French an asset
• Self-driven, hands-on approach, target driven and strong problem-solving skills
• Collaborative team player with open and flexible attitude combined with sound judgement and attention to details
• Proficiency MS-office, SharePoint, and Project Management tools
• Swiss based candidates with valid residency & work permit

Application

If qualifying for this opening, please apply by sending a detailed resume and motivation letter in English to the email address RH@ich.org. No recruitment agencies.