ICON
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Roles and Responsibilities
- 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.
Qualifications and Experience
- Minimum requirement of a bachelor’s degree; Master's degree preferred.
- 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.
