Medical Writer cum Project Manager

Responsibilities:

·        Proposal writing including methodology and quotations aspects

·        Verification of the proposals

·        Write study protocols and reports

·        Communicate scientific understanding to internal and external clients

·        Organise and ensure the follow-up and management of the ongoing clinical research and epidemiological projects.

·        Management of the project and the documents necessary for the client.

·        Manage regulatory issues before the project starts

·        Coordinate the study and manage its timeline

·        Manage and train the internal and external project participants (data-manager, fieldwork…)

·        Client relations and provision of follow-up

·        Information exchange with all participants in order to reach project objectives with the best cost and  liability conditions

Requirements:

Qualifications & Experience

·        A medical / life sciences degree and preferably a PhD

·        Agency or related healthcare or pharmaceutical industry experience in medical writing

·        Knowledge of statistics and data management

·        Knowledge of clinical research GCP and ICH

Competencies

·        Excellent writing and editorial skills

·        Ability to effectively analyze and research information

·        Able to work as part of a multifunctional team

·        Able to express scientific understanding creatively and flexibly to internal and external clients

·        Proficient in using Word, PowerPoint

·        Multitasking and flexible

·        Willing to travel where necessary

·        Independent

·        Detailed and organized