Medical Writing Review Senior Specialist (Remote)

About the position Responsibilities • Independently performs content, editing, and formatting QC of moderately complex regulatory and clinical study documents, including complex CSRs, protocols, Investigator Brochures, and Module 2 summaries. • Ensures QC reviewed documents comply with MWS Style guide and templates. • Troubleshoots MWS processes, tools, and technologies, serving as a subject matter expert. • Uses electronic document management systems (EDMS) to retrieve QC sources and track document dependencies. • Assists MW Scientists with the collection and maintenance of literature references in Endnote. • Contributes to MWS initiatives related to QC, document development, or process improvement. • Works cross-functionally to communicate responsibilities and track deliverables for complex CSR Appendices. Requirements • A minimum of 4 years of relevant work experience in review and QC of complex clinical and regulatory documents. • Advanced proficiency with Microsoft Office (Word, PowerPoint, Excel) and the use of templates. • Expertise using Endnote for citation management. • Experience with in-house style guide standards for editing and formatting. • Working knowledge of clinical development and regulatory affairs documentation. • Experience retrieving and filing documents within an electronic document management system. • Excellent interpersonal, verbal, and written skills with the ability to effectively manage stakeholders. • Conscientious, self-motivated, organized, and able to independently manage multiple projects with aggressive timelines. Nice-to-haves • Experience in a remote work environment. • Ability to solve routine problems with limited supervision and adapt to new work requests with minimal instruction. Benefits • Medical, dental, and vision benefits • Generous paid time off, including a week-long company shutdown in the Summer and Winter • Educational assistance programs including student loan repayment • Generous commuting subsidy • Matching charitable donations • 401(k) plan • Annual bonus and equity awards Apply tot his job Apply To this Job