1. Bachelor's degree required. Bachelor's degree in Science, English or Communications preferred.
2. 4-6 years relevant industry experience in medical writing or a related area such as clinical research, drug development, quality assurance/control, regulatory, report/submission publishing, or product support/R&D.
Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
3. 1 year project management experience in MWOs (Medical Writing Coordinating/Report Publishing and Documentation Specialists, Quality Control, and/or WP&S) or related area, including scheduling work and managing resources/workload (anticipated/unanticipated requests, time/resource management).
4. Experience managing employees preferred or demonstration of successful coaching/mentoring in a matrix environment. Ability to assist in the selection, building, management, oversight, resource planning/allocation of functional resources, leadership, development, and direction for direct staff.
5. Expert knowledge and application of global regulations, requirements and guidance associated with clinical regulatory document preparation and submissions and the ability to advise others regarding compliance with regulations and to apply towards the development and maintenance of business processes, job aids/tools, and training. Knowledge and expertise with Common Technical Document content templates.
6. Extensive experience in working with collaborative, internal/external cross-functional teams building effective working relationships with a leadership track record across all levels of the organization.
7. Excellent communication (oral, written, interpersonal, organizational), planning, execution, and team leadership skills. Superior attention to detail. Ability to influence current thinking and without direct authority. Developing strength in personal and technical leadership. Analytical/critical thinking and conflict management skills at operational and tactical levels.
8. Competent in the application of Medical Writing Operations business processes.
9. High degree of proficiency, skill, and knowledge in computer literacy (hardware and software)/technical skills (ability to apply towards process improvements/operational efficiencies/automation).
10. Proficient skills and knowledge in Microsoft Office Products (Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, Word) and Adobe in Windows operating system environment required. Proficient skills and knowledge in Microsoft document file formats (DocX) or other style file format tools, publishing software, and content management archival system(s) for eTMF/eSubmissions (Veeva Vault, CARA). Proficient skills and knowledge in reference management software (e.g., EndNote).