Job Discription
Description
Serves as a senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory while serving as primary technical contact with the internal team and the client.
.Serves as peer reviewer on internal review team providing review comments on draft and final documents.
.Performs on-line clinical literature searches, as applicable.
.Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
.Completes required administrated tasks within the specified timeframes.
.Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).
Qualifications
.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 and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
.Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership 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.
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