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
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
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
