Medical Writer creating impactful documentation for clinical studies and regulatory submissions. Collaborating with internal teams and ensuring clarity and compliance in scientific communications.
About the role
- Medical Writer I ensuring data integrity and quality checks for clinical documents in a biopharmaceutical company. Collaborating with medical writing teams and participating in stakeholder meetings.
Responsibilities
- Conducts data integrity reviews of assigned documents to ensure accuracy and consistency across text, tables, and figures
- Cross-checks scientific content against cited references
- Verifies correct interpretation of scientific data from referenced sources
- Ensures all statements are appropriately source annotated
- Participates in internal and client-facing meetings
- Monitors timelines and budgets for assigned projects
- Serves as a member of the medical writing team for projects
- Provides feedback to the lead medical writer
- Copyedits assigned documents
- Manages assigned projects according to medical writing standard operating procedures
Requirements
- min 1 year of MW experience
- experience in data and content QC review
- experience reviewing extracts, manuscripts, posters, and figure/table outputs (scientific QC)
- strong knowledge of relevant guidelines
- good understanding of deliverables and data QC processes
- familiarity with FDA, EU, and other relevant guidelines
- Bachelor's degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience
- Proficiency in Microsoft Office Suite
Benefits
- Professional development opportunities
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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