Job Description
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
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