Clinical Development Medical Writer Lead
hace 6 días
Company Overview
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.
About Us
We are an agile team driven to accelerate the delivery of therapies because we are passionate about changing lives.
Job Responsibilities
Mentor and lead less experienced medical writers on complex projects as necessary.
Act as lead for assigned writing projects.
Key Tasks
Develop or support various documents including but not limited to:
• Clinical study protocols and amendments;
• Clinical study reports;
• Patient narratives;
• Clinical development plans;
• IND submissions and annual reports;
• Integrated summary reports;
• NDA and CTD submissions;
• Investigator brochures;
• Clinical journal manuscripts;
• Abstracts;
• Client presentations.
Critical Skills
Identify and propose solutions to resolve issues and questions arising during the writing process.
Review statistical analysis plans and specifications for content grammar format and consistency.
Working Environment
Collaborate with department heads 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 teams providing comments on draft and final documents.
Requirements
Adhere to established regulatory standards including ICH-E3 guidelines Company Standard Operating Procedures client standards and approved templates when completing medical writing projects on time and on budget.
Perform online literature searches as applicable.
Maintain familiarity with current industry practices and regulatory requirements.
Benefits
$120,000 - $150,000 per year salary range based on experience location and qualifications.
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