Effective Project Management for Regulatory Documents During the Document Process
Medical writers often bear the responsibility of juggling multiple writing regulatory writing projects simultaneously on a daily basis. Writing is top priority, but so is project management. In order to pave the path to a successful regulatory document, a medical writer must possess strong project management skills. This includes not only the management of document content, but also the management of the process, timelines, and people (multiple team members from a variety of functional areas). The following webinar series will focus on effective project management strategies for medical writers.
This webinar will focus on organization, communication, and process during the document process.
At the conclusion of this webinar, attendees will be able to
- Organize themselves and their teams during the document process
- Manage the timeline
- Know when to communicate and how
- Plan and lead strategic key result/content meetings
- Initiate productive document reviews and consolidate and resolve review comments
Learning Level: Basic, Intermediate
Content Area: Practical Skills, Regulatory
About the speaker: For over 12 years, Lynne Munno has been working in the pharmaceutical industry as a medical writer in a variety of therapeutic areas, working on clinical documents for regulatory agencies and investigators, among other audiences. Lynne is currently an Associate Director of Medical Writing at Deciphera, Pharmaceuticals. Prior to this, Lynne has held medical writing positions both in the pharmaceutical industry (Pharmacyclics [an AbbVie company], Sanofi, AVEO Oncology, and Alkermes) and in clinical research organizations (Quanticate and ORA, Inc.). Lynne is a graduate of the University of Connecticut (B.A. in English and Sociology), University of Massachusetts Dartmouth (M.A. in Professional and Technical Writing), and the University of Sciences in Philadelphia (M.S. in Biomedical Writing).