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Writing, managing, leading: the multifaceted role of a successful medical writer

It’s readily apparent that medical writers charged with preparing dossiers for submission to regulatory authorities must be excellent communicators. But what’s less obvious is the degree to which other skills determine the success of the effort; project management expertise and leadership qualities are vital assets in medical writers. 

 

Preparing a regulatory submission involves managing a multi-disciplinary team, setting clear goals, creating and adhering to a critical project schedule, and meeting quality standards. Much rests on how the medical writing team sets and shares a direction, plans tasks, coordinates multiple fast-moving activities, and resolves differences – all in addition to how they communicate an asset’s safety, efficacy, and suitability. 

The ideal skillset

To excel, medical writers must demonstrate, beyond superior communication abilities:

  • Attention to detail
  • Creativity
  • Project and time management expertise
  • Proficiency with various software programs

The medical writing function can, of course, be outsourced to a partner employing specialists in the area. Indeed, from a recent webinar on the topic, we learned that approximately a third of the audience currently outsources medical writing, while another nine percent were exploring that as an option. Let’s review some of the most essential leadership qualities and practices that sponsors should expect from their medical writers, whether from in-house staff or a partner’s team.

Developing the project plan

Medical writers’ work begins long before the first key stroke. They must convene a kick-off meeting to train all involved on their role, explain the tasks ahead, and clarify the standards expected. They must then develop a project plan with input from all key stakeholders to define the scope of the project, assign responsibilities, and lay out a detailed timeline. The plan should include a storyboard of the key messages to be conveyed and a checklist that maps out who will provide what information for each module of the dossier. 

Setting expectations and building consensus 

Medical writers must brief reviewers at the onset of the project, ensuring that they share a common understanding of what is expected of them - not only in terms of how and when they will be called upon, but also in terms of the types of comments they should provide. Will their focus be on scientific accuracy, compliance, or formatting? 

Providing regular updates

The entire, cross-functional submission team should continue to meet regularly over the course of the project to discuss the status of each component and identify issues proactively. Such regular check-in points allow all writers to stay informed, the leader to check on the progress of co-authors, and team members to share helpful tips and tricks.

Resolving conflicting comments 

Addressing conflicting or non-consolidated comments from reviewers is typically one of the greatest and most time-consuming challenges medical writers face. By holding and facilitating structured comments resolution meetings (CRMs) (with mandatory attendance), the writing team can gain clarity on comments and seek alignment from reviewers.  As a last step, reviewers should be gathered at a signature meeting to document their final approval. 

Maintaining control of quality 

Medical writers should be aiming for consistency in the terminology used in the dossier, the standards applied, and the information that flows from one document to the next. Such consistency is, in fact, the key driver in reducing errors and ensuring compliance with regulatory expectations. Effective methodologies for controlling quality include enlisting a team of reviewers who have not been involved in drafting the document, employing industry software for quality checks, and dispensing style guides, cheat sheets, and customised checklists to those reviewing and validating the documents.

Shortening the timeline

Without cutting corners or sacrificing quality, the preparation timeline can be as short as possible when medical writers practice a few “tricks of the trade” to keep the process moving efficiently. While this is far from an exhaustive list, much time can be saved by:

  • Developing shell documents upfront that contain all of the necessary sections, minus any final study results. In this way, a great deal of approved text can be “locked down” so that it will not be revisited and revised in future review cycles
  • Conducting quality control on a rolling basis as portions of the work reach maturity rather than waiting for the final stages when all components are done
  • Using authoring and editing tools to support collaboration, document management, and the flow of information between modules. 

As they usher a submission package through the various stages of compilation, review, quality control, editing, and completion, medical writing teams must have strong leaders who can set the direction for the project, ensure alignment across diverse stakeholders, promote transparency, and ensure accountability for meeting deadlines and quality standards. Through a combination of careful planning and ongoing project management, medical writers can minimise the risk of queries from regulators and delays in the document’s preparation and approval.

Ultimately, it is the combination of scientific expertise, project leadership, and proactive communication that empowers medical writers to deliver high quality submissions on time, with confidence, and with fewer regulatory hurdles.

 

For more information on ICON’s comprehensive medical writing solutions, visit ICONplc.com/medicalwriting. 

Contact us to discover how our expertise can flexibly support your needs across all major areas.

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