Job Description

Experienced Medical Writer with a strong career history of contributions to Medical Writing group, including involvement with best practices/tools/applications and surveillance of changes in Medical Writing norms per American Medical Writers Association guidelines. The Principal Medical Writer applies advanced knowledge within or across multiple disciplines and leads special projects while overseeing the on-the-job training aspects for all Medical Writers on the team. Serves as Medical Writer subject matter expert on Medical Writing tasks. Manage all project tasks for the department’s most complicated, urgent, high visibility, or challenging projects; lead CFT meetings to drive to resolution and project task completion. Propose and implement process improvements, including writing process improvement charters, identifying CFT members, obtaining stakeholder agreement, presenting recommendations to upper management, and executing steps to implement. Train team members on guides, templates, checklists and/or job tools, good writing practices and Medical Writing norms. Develop and maintain training strategy for team members and ensure team members are trained. Review training expectations and strategies with management to ensure adequate training completion as well as for alignment with team members’ development plans. Maintain the guides used to create instructions for use documents and associated DIV form used to document source documents used in labeling creation; implement current regulatory feedback, ensure guide is correct/accurate and reflects most current information. Lead CFT meetings to obtain agreement on changes with stakeholders. Participate on and present changes to Labeling Process Community. Maintain the best practice document and chapter templates used for outside-of-US submission document creation. Implement current regulatory feedback from country affiliate managers, ensure best practice is correct/accurate and reflects most current information. Participate on and present changes to IRIS Process Community. Maintain templates and checklists used for US submission document creation. Implement current regulatory feedback, ensure templates are correct/accurate and reflect most current information. Stay up-to-date on eSTAR versions and assess new versions for impact on templates and checklists. Maintain study record templates and user guides for study record creation. Implement current regulatory feedback, ensure templates and user guides are correct/accurate and reflect most current information. Create new templates/user guides as new study designs are created. Present changes to users. Maintain troubleshooting guide templates. Implement global service and support feedback.

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