Technical Writer- Life Sciences
Covance's BioAnalytical lab is seeking a Life Sciences Technical Writer for their Early Development- BioAnalytical, Chantilly, VA site. 3-4 years of study coordinator experience required, nonclinical preferred.
Responsibilities:
– Drafts protocols, sample analysis outlines (SAOs), amendments and study schedules as appropriate, using proposal outline or client-supplied information.
– Reviews study compliance against protocol, SOP, and regulatory agency guidelines.
– Develops new report formats as needed, including client specific formatting.
– Drives process improvement to increase the efficiency of daily/routine procedures, reporting methods, and departmental practices.
– Serves as the primary contact in communication and interaction with other departments and clients as applicable.
– Updates and maintains project tracking systems as appropriate. Provides input on new technologies, system changes, and enhancements.
– Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, including scheduling and leading meetings as required.
– Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
– Assists in interpreting and evaluating data for reports.
– Maintains well documented, organized, and up-to-date study files including study schedule, protocol, and correspondence, as applicable.
– Reviews QAU report audits and submits audit responses for approval as appropriate.
– Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
– Drives report productions through finalization, including archival of data as appropriate.
– Prepares for, participates in and learns to host routine client visits.
– Manages data transfer to clients as requested.
– Monitors and schedules study phases in coordination with SD/PI.
– Trains and mentors less experienced staff in all aspects of the study coordination position.
– Assists SD/PI in monitoring the financial status of ongoing studies, as appropriate.
– Assists in development of departmental policies, procedures, and training manuals.
– Develops an area of expertise within the department, serves as a resource by providing individual and group training and written instructions.
– Backs up Study Coordination Supervisor by leading team meetings and taking minutes as appropriate.
– Performs other related duties as assigned.
Requirements:
Education/Qualifications
– Bachelor of Science (BS) degree in science.
– Experience may be substituted for education.
– Efficient use of word processing software, database, spreadsheet, and specialized software.
– Proficient in concise writing; writing should require little or no external review or edit.
– Adherence to grammar, punctuation, composition, and spelling according to company standard conventions.
– Experience on a variety of studies performed in the department and exposure to a diverse client base.
– Knowledge of regulatory agency guidelines. Experience
– Four years of Study Coordinator or related experience.
– Excellent communication, presentation, and interpersonal skills.
– Excellent attention to detail.
– Efficient in prioritizing and managing time.
