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.

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 proposals, service orders, and agreements
• ​Contribute to the Regulatory Affairs department budget preparation
• ​Communicate and co-operate with vendors, consultants, and key experts
• Serve as backup for other team members as required

Requirements

• ​MSc or higher degree in Medicine, Pharmacy, Public Health or Life Sciences
• ​PhD degree is preferred but not essential
• ​At least 5 years experience in medical or scientific writing
• ​Previous mentoring or line management experience is preferred
• ​Strong scientific background 
• ​Fluency in native language and English
• ​In depth knowledge of 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

Benefits

• 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