Senior Medical Writer: Complex Projects
hace 1 mes
About the Role
As a Senior Medical Writer at Syneos Health, Inc., you will be responsible for mentoring and leading less experienced medical writers on complex projects, as well as acting as lead for assigned writing projects. You will manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
Key Responsibilities
- Develop and support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, annual reports, integrated summary reports, NDA and eCTD submissions, investigator brochures, and clinical journal manuscripts and abstracts.
- Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as necessary.
- Review statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
- Serve as peer reviewer on internal review team providing review comments on draft and final documents.
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