San Rafael, California | Contract
The Medical Writer applies advanced documentation preparation and document project management skills to lead the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
- Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
- Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’ s brochures and periodic safety reports (PSURs, DSURs, etc.)
- May provide peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
- Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
- Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
- Works effectively with cross-functional groups
- Other tasks as assigned.
Strong preference for this individual to be onsite. Remote candidates will be considered but must be willing to travel to the office as needed.