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.Minimum requirement of a bachelor’s degree; Master's degree preferred3-5 years Medical Writing experience or other relevant pharmaceutical experience combined with scientific and regulatory knowledgeStrong 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 PRA
