Guide to controlling risks in medical writing reviews

Dr. Laura Oberthur-Johnson

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Spot risks early, cut the comment chaos and stick to timelines.

When it comes to managing document reviews effectively, medical writers are often the unseen guardians of process integrity. Their role is critical—not just in ensuring document quality, but also in mitigating risks, maintaining compliance and streamlining workflows. However, the challenges of juggling comment chaos, tight timelines and resource constraints are monumental without a structured approach.

Key responsibilities of document process guardianship

Discover the key responsibilities involved in document process guardianship, ensuring accuracy, compliance and efficient management.

Managing risk to prevent costly mistakes

Learn how effective risk management can help you avoid costly mistakes and protect your business.

How to keep timelines on track and foster accountability

Learn effective strategies to keep project timelines on track and promote accountability within your team.

Leveraging technology to unify teams and streamline review cycles

Streamline teamwork and simplify review cycles with innovative technology solutions.

Transforming document development

This guide provides actionable strategies for medical writers and leaders to transform their approach to document development. By emphasizing document process guardianship, we outline how to embed preventative measures into your workflows and improve collaboration through centralized tools.

Along the way, you'll learn to tackle some of the most common hurdles in document reviews, mitigate risks and safeguard both quality and compliance.

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About the author

Laura brings over 20 years of expertise in medical writing, spanning scientific, regulatory, and real-world projects. She notably spent more than ten years leading medical writing teams at PPD, a global CRO.

Her passion lies in finding smarter, more collaborative ways to enhance team workflows, mitigate risks and deliver precision-driven results.

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Download the guide now

Download the guide now to streamline your document development process, enhance collaboration, and ensure quality and compliance every step of the way.