Description

Medical Writer I

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. 
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Job responsibilities
•    Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision. 
•    Develops or supports, a variety of documents that include but not limited to:
     o    Clinical study protocols and clinical study protocol amendments;
     o    Clinical study reports;
     o    Patient narratives;
     o    Investigator brochures. 
•    Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required. 
•    Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. 

•    Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. 
•    Performs on-line clinical literature searches, as applicable. 
•    Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills. 
•    Is aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. 
•    Completes required administrated tasks within the specified timeframes. 
•    Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

What we’re looking for
•    Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
•    Extensive knowledge of English grammar with a familiarity with AMA style guide. 
•    Understanding of FDA and ICH regulations and guidelines strongly preferred. 
•    Demonstrated effective presentation, proofreading, and interpersonal, skills and ensure a team-oriented approach. 
•    Strong proficiency in Word, Excel, PowerPoint, email, and Internet. 
•    Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. 

Apply : https://incresearch.taleo.net/careersection/ex/jobdetail.ftl?job=21004337&lang=en&src=SNS-10160