Senior Medical Writer
ICON
- United Kingdom
- Permanent
- Full-time
- Independently produces clinical and regulatory documents in collaboration with Principal Medical Writers . These documents may include clinical study level documents such as Clinical Study Protocols or Clinical Study Reports. This includes Phase 1 in patients to Phase 3 across multiple therapeutic areas.
- Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies.
- Acts as the primary contact for the study team in relation to the preparation and timelines (incl. planning) of assigned documents.
- Facilitates the review of the documents and ensures that documents are submission-ready and finally approved. When preparing documents you will be directly in contact with QC personnel and publishing specialists who support you in document preparation.
3-5 years Medical Writing experience or other relevant pharmaceutical experience combined with scientific and regulatory knowledge
Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured messages.
Proficient in independently writing several types of clinical/regulatory documents (mainly CSRs, Protocols) including leading creation, coordination of the authoring functions, facilitation of the review of the documents and ensuring that documents are submission-ready and finally approved.#LI-Remote