The role manages and conducts quality reviews to support delivery of accurate, compliant, and submission-ready documents prepared by authors in Medical Writing and other clinical groups. Documents include (but are not limited to) protocols, clinical study reports, disclosure documents, clinical summaries/overviews for marketing applications, briefing documents, regulatory responses and related correspondence and presentation materials.JOB RESPONSIBILITIES
- With minimal supervision, perform quality reviews and participate to quality projects in accordance with agreed upon timelines.
- Verify accuracy of document content using source documents including clinical regulatory documents (e.g., protocols, clinical study reports, CIOMS reports, clinical summaries/overviews) and data tables, figures, and listings.
- Verify internal consistency within a document and across related documents
- Verify uniformity and compliance of documents with internal and external standards (e.g., document templates, company style guide, publishing requirements).
- Record findings and identify appropriate corrections to address findings.
- Collaborate with document authors and other team members to resolve findings.
- Identify, communicate, and resolve issues impacting document timelines.
- Propose recommendations for process improvements that could reduce recurring errors in documents.
QUALIFICATIONS / SKILLS
- Participate in quality processes and process improvement initiatives.
- Contribute to the training of colleagues on quality standards and processes.
- At minimum Bachelor degree, preferably in a life science discipline. Advanced degree preferred.
- BS/BA +5 years, MS/MA +3 years of experience in document QC and/or medical writing in the pharmaceutical or biotech industry.
- Ability to work with minimal supervision. Ability to work well under pressure and adapt to change as needed.
- General understanding of medical terminology, clinical trials, and drug development process.
- Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
- High degree of fluency in written and spoken English.
- Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships.
- Proficiency with computer applications (e.g., Adobe Acrobat, MS Word, MS Excel, MS PowerPoint).
This role can be site or remote based.PHYSICAL/MENTAL REQUIREMENTS
n/aNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
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