Medical Writing Review Senior Specialist (Remote)
Posted 2025-08-15
Remote, USA
Full Time
Immediate Start
About the position
The Medical Writing Operations Senior Specialist is responsible for conducting in-depth quality control (QC) reviews of moderately complex clinical and regulatory documents across various therapeutic areas. This role provides QC expertise to the Medical Writing Operations team and supports Medical Writing Scientists in preparing high-quality, compliant documents by utilizing essential tools and technologies.
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
The Medical Writing Operations Senior Specialist is responsible for conducting in-depth quality control (QC) reviews of moderately complex clinical and regulatory documents across various therapeutic areas. This role provides QC expertise to the Medical Writing Operations team and supports Medical Writing Scientists in preparing high-quality, compliant documents by utilizing essential tools and technologies.
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