Scientific (Medical) Writing Lead

Job description

Join our Regulatory Affairs department as a Scientific (Medical) Writing Lead . Position is in any EU country. ​ Scientific Writing Lead ​prepares clinical and regulatory documentation as a hands-on medical writer, leads and supports the Scientific Writing team operationally and coordinates scientific writing projects. Role responsibilities: - Act as lead for the Scientific Writing team - Coach, guide, and support team members - Plan and coordinate job tasks, define resources and information required for the execution of the tasks - Serve as the primary point of contact for medium - high complexity Scientific Writing projects - ​​Act as the lead with respect to content and scientific strategy in complex projects - ​Development / review / update of SOPs, Working Instructions, Job Descriptions and etc. - ​Write/review/assess a range of scientific documents - ​Assess documents for marketing authorisation of medicinal products, clinical studies, other biomedical research to make conclusions and recommendations - Contribute to the development of regulatory strategy & clinical research program - Participation and contribution in audits - ​Contribute to the preparation of financial propos...