Job Description

Description JOB SUMMARY 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. JOB RESPONSIBILITIES Mentors and leads less experienced medical writers on complex projects, as necessary. Acts as lead for assigned writing projects. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Compiles, writes, and edits medical writing deliverables including operating guidance documents, SOPs, training guides, etc., and serves as a medical writer within and across departments with minimal supervision. Ability to create process maps from provided technical material or from client inputs. Hands on experience of using MS Visio or similar tools. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. . Serves as peer reviewer on internal review team providing review comments on draft and final documents. Adheres to established regulatory standards 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. . Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing. Maintains awareness 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 . 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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