Scientific; Medical Writing Lead

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.

• Act as lead for the Scientific Writing team
• Coach, guide, and support team members
• Plan and coordinatejobtasks, define resources and informationrequiredfor the execution of the tasks
• Serve as the primary point of contact formedium
  -high complexity
  
  Scientific Writingprojects
• Act as the leadwith respectto content and scientific strategy incomplex projects
• Development/ review/ updateof SOPs, Working Instructions, Job Description s and etc.
• Write/review/assessa 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 contributioninaudits
• Contribute to the preparation of financial proposals, service orders, and agreements
• Contribute to the Regulatory Affairsdepartmentbudget preparation
• Communicate and co-operatewithvendors, consultants,and key experts
• Serve as backup for other team members as required

• MSc or higher degree in Medicine, Pharmacy, Public Healthor Life Sciences
• PhDdegree is preferred but not essential
• At least5years experience in medicalor scientificwriting
• Previousmentoring or line management experience is preferred
• Strong scientific background
• Fluency in native language and English
• In depthknowledgeof clinical development process, regulatory procedures,and relevant industry guidelines
• Good understanding of basic human anatomy and physiology
• Basic knowledge of biostatistics
• Scientific writing competency
• Good knowledge of MS Word, Excel, PowerPoint, Outlook, reference management software, etc.
• Continuous professional learning and development
• Attention to details
• Ability to prioritize and work to deadlines with high quality
• Ability to work independently and within the team

• International team and environment
• Professional growth and career opportunities
• Bonus based on annual performance
• Additional bonus system – Instant reward and Recognition program
• Personal accident and business trip insurance
  
  Additional health insurance
• Workplace establishment allowance (only fully home-based)
• Influenza vaccines
• Rewarding referral policy
• Remote work possibility & flexible working hours