Join our Regulatory Affairs department as a Scientific (Medical) Writing Lead. Position is in any EU country.
Si cree que es el candidato ideal para la siguiente oportunidad, envíe su solicitud después de leer la descripción completa.
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 coordinatejobtasks, define resources and informationrequiredfor the execution of the tasks
- Serve as the primary point of contact formedium -high complexityScientific Writingprojects
- Act as the leadwith respectto content and scientific strategy incomplex projects
- Development/ review/ updateof SOPs, Working Instructions, Job Descriptions 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
- Contributeto the preparation of financial proposals, service orders, and agreements
- Contributeto the Regulatory Affairsdepartmentbudget preparation
- Communicateand co-operatewithvendors, consultants,and key experts
- Serve as backup for other team members as required
Qualifications:
- MSc or higher degree in Medicine, Pharmacy, PublicHealthor Life Sciences
- PhDdegree is preferred but not essential
- At least5years experiencein medicalor scientificwriting
- Previousmentoring or line management experience is preferred
- Strong scientific background
- Fluency in native language and English
- In depthknowledgeof clinical developmentprocess, regulatory procedures,andrelevant 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. xqysrnh
- 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 insuranceAdditional health insurance
- Workplace establishment allowance (only fully home-based)
- Influenza vaccines
- Rewarding referral policy
- Remote work possibility & flexible working hours