Scientific (Medical) Writing Lead - Remote

Overview

Join our Regulatory Affairs department as a Scientific (Medical) Writing Lead. Position is in any EU country.

In Short

• 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, 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

Requirements

• Experience in scientific writing
• Knowledge of regulatory affairs and clinical research
• Strong leadership and team management skills
• Ability to coordinate complex projects
• Excellent communication skills
• Experience in writing SOPs and other regulatory documents
• Strong analytical skills
• Ability to work under pressure and meet deadlines
• Experience in budget preparation and financial proposals
• Familiarity with audits and compliance processes

Benefits

• Opportunity to lead a team in a dynamic environment
• Engagement in meaningful projects in the medical field
• Professional development opportunities
• Collaboration with experts and vendors
• Flexible working arrangements