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Always Keeping a Ball in the Air: Project Management in Medical Writing

Medical Writing Publication Topics

Day & Time:
March 11, 8:30AM - 10:00AM

Room Number:
Ballroom Salon I


Always Keeping a Ball in the Air: Project Management in Medical Writing

Robin Whitsell
Whitsell Innovations, Inc., United States

The authoring of regulatory and publication documents require organizing the interdependencies of deliverables and establishing timelines. A delay in one deliverable can easily result in significant downstream effects that may ultimately delay submission and impact the overall business plan. The medical writer must effectively build relationships between team members and manage the overall process by setting timelines and leading individuals to succeed in their tasks. Project management tools can help facilitate this communication, manage timelines, and identify rate-limiting steps to minimize delays.

In this session, we will present ideas on:
Identify how medical writers are integrated into companies and recognize the key interactions with other functional areas (eg, statistics, pharmacology, data management, clinical, operations, etc). Discuss best practices of how in-house medical writers and external writing support are coordinated.
Discuss different project management models used in industry. Identify different medical writing tools (Gantt charts, metrics, work flow diagrams, etc) and describe best practices in project management in medical writing. Do team dynamics determine which tool/approach to select?
Recognize how to be a more impactful as a leader/project manager. Medical writers are often project managers who are forced to lead with various levels of influence and authority over their teams.

Learning Objective(s):
At the conclusion of this session, participants should be able to:
Discuss best practices for team implementation
Define tools, metrics, and how to apply these to specific teams
Describe how to maximize a team's impact through project management

Presentation(s) & Speaker(s):
Entering the Arena – Can I Tame the Lions? One Medical Writer’s Approach to Document Management in a Team Environment
Amy Holbrook, MS
Lead Medical Writer
Takeda Pharmaceuticals International Co., United States

Smoothing the Bumps in the Process Road: Effective Tools for Medical Writing Program Management
Cynthia Gates, PhD
Senior Medical Writer
Biogen Idec, United States

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