Scientific (Medical) Writing Lead
Biomapas
Posted: February 19, 2026
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Quick Summary
Join our Regulatory Affairs department as a Scientific (Medical) Writing Lead in Romania. As a Scientific Writing Lead, you will prepare clinical and regulatory documentation, lead team members, and coordinate scientific writing projects.
Required Skills
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 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