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Session 3 Track 2: The Role of the Regulatory Submission Lead
Session Chair(s)
Elizabeth Brown, MS, PMP
Executive Director, Medical Writing & Disclosure
Merck & Co., Inc., United States
The importance of developing future medical writing (MW) leaders applies across all disciplines and roles within the profession, but strong leadership is of upmost necessity in the role of regulatory submission lead. The submission lead must not only have expertise in the clinical documents, agency regulations, and interpretation of scientific data, but also possess a strategic mindset and diverse skillset to successfully guide cross-functional teams.
In this session, a panel will discuss the role of the submission lead from various perspectives. The responsibilities of the role in leading teams through the regulatory submission process (eg, content development, consistent messaging, timeline stability, etc) will be reviewed. The impact of effective (and ineffective) submission leads on their teams’ ability to achieve on-target quality deliverables will be shared. The successful development of MWs to become effective and strategic submission leaders will be explored.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify the roles and responsibilities of the regulatory writing submission lead
- Recognize the qualities of an effective submission lead and the impact of ineffective leadership
- Develop writers to be successful at leading submissions
Speaker(s)
Speaker
Brenda Taylor, MS
Certara, United States
Director, Global Submissions
Speaker
Lisa Ambrosini Vadola, PhD, MA
Whitsell Innovations, Inc., United States
Manager, Medical Writing
Speaker
Sheryl Flores, PhD, MBA
Merck & Co., Inc., United States
Director, Vaccines Medical Writing Lead
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