Biopharma company based in South SF focused in the areas of Immunology and Inflammation.
The Medical Writer applies project management skills to participate and/or lead in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
Draft and edit documents used in conducting and reporting the results of clinical studies, including investigator brochures and clinical study reports but may also include protocols, protocol amendments, and informed consent forms
Manage study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Provide peer review and editing support for other clinical / regulatory documents, such as safety reports, statistical analysis plans, PK/PD reports, and other study materials as needed
Assist in developing and reviewing standard processes and templates within Clinical Medical Writing
At least 6 years of medical or scientific writing experience as a primary job responsibility (10 years preferred), including at least 3 years as a clinical or regulatory medical writer in the pharmaceutical industry
Experience writing BLA/MAA submissions (Module 2 and 5 documents), IND/CTA submissions, investigator's brochures, periodic safety reports, and informed consent documents