Senior Medical Writer
hace 4 días
Job Summary
As a Senior Medical Writer at Syneos Health, you will play a critical role in the development of clinical study protocols and reports. You will lead a team of medical writers and be responsible for managing medical writing activities associated with individual studies. Your expertise in regulatory compliance and medical writing will ensure that all documents meet the highest standards of quality and accuracy.
Key Responsibilities
- Mentor and lead less experienced medical writers on complex projects
- Act as lead for assigned writing projects
- Manage medical writing activities associated with individual studies
- Develop or support a variety of documents, including clinical study protocols, reports, and patient narratives
- Identify and propose solutions to resolve issues and questions arising during the writing process
- Review statistical analysis plans and table/figure/listing specifications for appropriate content and grammar
- Interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs
- Serve as peer reviewer on internal review team
- Adhere to established regulatory standards, including ICH-E3 guidelines
Requirements
- Strong expertise in medical writing and regulatory compliance
- Excellent leadership and communication skills
- Ability to work independently and as part of a team
- Strong analytical and problem-solving skills
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
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