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
