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Clinical Document Specialist
hace 3 semanas
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Job DescriptionThis position is responsible for the quality control review of clinical documents intended for submission to health authorities worldwide. The Senior Clinical Editor will copyedit/proofread, format, and verify data content in clinical documents in accordance with company SOPs and processes to ensure documents meet required standards. They may oversee the workload for editors, establishing schedules and interacting with cross-functional authors.
Key Responsibilities:- Perform QC review of documents (e.g., clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents) to ensure compliance with the Incyte Style Guide and submission standards.
- Verify data in documents against the source tables, figures, and listings and format tables according to Incyte standards.
- Copyedit/proofread clinical documents for grammar, style, and formatting according to AMA style guides.
- Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect source documents or data (e.g., SAS tables and listings).
The ideal candidate will possess excellent editing and communication skills, as well as experience working with clinical documents. Strong attention to detail and ability to work independently with minimal oversight are essential.
About UsSyneos Health is committed to developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
BenefitsWe offer a competitive salary range of $95,000 - $110,000 per year, depending on experience, plus benefits and opportunities for career growth and professional development.
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