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
