Education and Related Experience
Manages outsourced medical writing projects, primarily clinical submission documents for the FDA and other regulatory authorities worldwide. This includes but is not limited to:
- Review of deliverables against quality and in-house standards.
- Coordination of development activities with the company Operations Team members.
- Issue resolution.
- Quality control of non-published and published deliverables.
- Vendor assessment and day-to-day vendor oversight.
- Project needs assessment (time and materials).
- Timeline management.
- Training of external vendors on company SOPs and business processes.
- Budgeting and contract management.
- Dispute resolution with vendors.
• Authors and/or edits key regulatory documents as needed, including but not limited to protocols, clinical study reports, investigator’s brochures, annual reports, briefing packages, and integrated data reports.
• Represents Medical Writing on project teams, including but not limited to attendance at team meetings, communication of project status and critical path issues, and provision of projected and actual dates to project management team for input into the timeline management system.
• Provides relevant and timely project information to the functional area head, ensuring that adequate coverage of medical writing needs is maintained in accordance with the company’s goals and objectives.
• Adheres to and helps maintain departmental SOPs and working practices, including the necessary model documents and style guidelines, for standardized processes and style expectations across projects.
• Provides backup support to other Medical Writing Managers.
• Solid knowledge of the clinical development process, good clinical practices, and the medical writing process.
• Solid understanding of the requirements of regulatory writing, including ICH guidelines.
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook) and Adobe Acrobat.
• Strong communication skills.
• Knowledge of how/when to apply organizational policy and/or procedures to a variety of situations.
Contact Edward if interested:
Edward A. Giorgi
Clinical Research Recruiter
Medical Staffinf Network Healthcare, LLC
5515 Security Lane, Suite 1109, Rockville, MD 20852
W: 301-945-9056 |C: 804-496-8886| F: 301-468-3485| firstname.lastname@example.org