Act as lead medical writer on clinical study reports, clinical study protocols, clinical development plans, informed consent forms, investigator brochures, patient narratives, and annual reports. Prepare documents in accordance with SOPs, guidelines, and customer requirements. Identify project needs, track project timelines, and implement client requests. Participate in both internal and external project team meetings and work directly with the customer on medical/technical writing issues.

Direct GLP preclinical toxicology studies with high-level attention to detail. Communicate clearly with client to implement study plan; write study protocols and procedures. Coordinate technical activities during study conduct by effectively communicating instructions and providing prompt decision-making. Write standard operating procedures and create data collection forms. Provide progress reports to clients during study conduct; answer all questions or issues that arise. Prepare written final study report for client by creating data tables and figures, summarizing data from statistical reports, and incorporating Quality Assurance Unit and client comments. Perform all other administrative study duties (e.g., maintain/track internal finances, organize subcontractors, review in life data, ship samples, order supplies, archive study materials, etc.).

Coordinated GLP preclinical safety pharmacology studies in conjunction with Study Directors. Communicated with clients to schedule new studies and write study protocols. Responsible for precise implementation of study tasks on schedule and according to protocol and overseeing technical staff. Conducted detailed review of in-life data—made corrections and requested missing documentation. Wrote draft study report for client; incorporated and edited/condensed peer review and client comments and finalized reports according to deadline. Worked with Quality Assurance Unit to resolve audit findings. Coordinated mailing of bulk test article, dose analysis samples, toxicokinetic samples, etc. Archived study materials following project finalization.

Trained and developed direct reports in all aspects of report writing process—the use of templates, data table generation, materials/methods preparation, and results compilation and formatting. Reviewed and edited reports written by direct reports—proofread/edited text, verified data vs. results, ensured compliance with internal style guide, protocol and regulatory guidelines. Provided continual support on data- and study-related issues, and assistance with grammar, punctuation, word processing, graph/figure generation and report publishing. Oversaw study scheduling and managed projects assigned to direct reports; prioritized work. Collaborated directly with clients to revise draft reports, resolve audits and finalize projects on schedule. Performed other supervisory duties including mentoring and evaluating work performance of direct reports, setting work schedule/priorities, managing report templates, conducting yearly reviews, etc.

Functioned as lead full-time writer for preclinical general toxicology and safety pharmacology studies. Managed multiple projects while maintaining high output and superb attention to detail. Wrote reports in accordance with internal style guides and regulatory guidelines. Generated data tables and figures; prepared materials/methods sections from in-life study records. Interpreted data tables/statistical output and wrote detailed results of each study. Served as initial quality control of in-life data and oversaw correction of any data issues. Reviewed initial draft report with the Study Director to ensure correct interpretation prior to peer review. Managed all aspects of the report finalization process to assure incorporation of peer review, Quality Assurance Unit audit findings and client comments. Worked successfully in fast-paced environment (wrote/mailed 3 to 5 reports per week). Published and printed reports; checked copy and mailed reports to clients.

Served as lead inhalation technician on preclinical acute, subchronic and reproductive toxicology studies. Assembled exposure atmosphere generation systems based on route of exposure and test article characteristics; monitored systems during study conduct. Maintained records in accordance with Good Laboratory Practices. Wrote report appendices detailing exposure methods/results.