Regulatory Medical Writing Lead
3 days ago
We are seeking a highly experienced Senior Oncology Writer to join our medical writing team at Stemline Therapeutics. As a key member of our group, you will be responsible for planning, writing, reviewing, and editing clinical documents related to oncology drug development.
About the Role
The ideal candidate will have a strong background in regulatory medical writing, with a minimum of 5-10 years of experience in the field. You will work closely with cross-functional teams to develop and implement document strategies, ensuring consistency and logic throughout all projects. Your expertise will ensure that all documents adhere to regulatory standards and accurately reflect scientific data.
Key Responsibilities
- Coordinate and author complex clinical documents, including study protocols, clinical study reports, and IND submissions.
- Participate in document subteams and ensure effective planning and management of timelines for assigned documents.
- Develop and implement document strategies, collaborating with cross-functional teams to ensure consistency and logic throughout all projects.
- Review and edit documents as required, resolving issues and errors with team members to ensure timely completion and high quality.
Requirements
- A bachelor's degree in biological or clinical sciences; a graduate degree (Master's, PhD, PharmD, or MD) is preferred.
- Fluent in English with proven ability to write complex scientific documents effectively.
- A minimum of 5-10 years of relevant experience in regulatory medical writing.
Benefits
- Opportunity to work on cutting-edge oncology projects
- Collaborative and dynamic work environment
- Comprehensive benefits package
Estimated Salary: £90,000 - £120,000 per annum.
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