Job Description

Quality Control & Quality Assurance

• Perform all quality control (QC) review types, including portable data format (PDF) publishing QC
• Maintain a daily QC tracker to capture details of all QC reviews performed by Medical Writing
• Coordinate with the Medical Affairs Coordinator to ensure all documentation (e.g., checklists, memos to file) relating to completed QC reviews are filed properly for audit trail purposes
• Participate in the development and timely update/revision of Quality Systems Documents, work instructions, business process descriptions and templates relating to QC for which Medical Writing is responsible

Departmental Support

• Set up cross-functional PSI reviews for all documents for which Medical Writing is responsible
• Perform tasks such as tracking appendices of a clinical study report; tracking preparation, review, and finalization of CSR safety narratives; or performing publishing (e.g., creating bookmarks and hyperlinks)
• Provide backup support to Medical Writing management, as needed

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Qualifications

• Relevant educational background, such as a Bachelor’s degree, or an equivalent combination of education, training, and experience that presents the required knowledge, skills, and abilities. Equivalency is defined as a minimum of a 2-year Associate’s degree in addition to 2 years of experience in quality control of medical, scientific, and/or technical documents.
• A minimum of 2 years of experience in quality control of documentation and data
• Prior pharmaceutical, biotechnology, or contract research organization experience is preferred
• Recent experience using advanced formatting tools in MS Word, specifically document formatting and/or correction using Microsoft Word styles and templates
• Experience editing documentation in Microsoft Word, Adobe PDF, and Microsoft Excel formats
• Familiar with Good Clinical Practice guidelines
• Demonstrated experience with PleaseReview, PerfectIt, and Adobe Acrobat DC is strongly preferred
• Demonstrated success working cross-functionally in a self-directed, remote working environment

Additional Information

All your information will be kept confidential according to EEO guidelines.