Job Description
Responsibilities:
Quality Reviews
- 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.
Special Assignments/Projects
- Participate in quality processes and process improvement initiatives.
- Contribute to the training of colleagues on quality standards and processes.
Qualifications/ Skills:
- Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
- 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).
Other Details
About Company
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