Poster Presentations from #AMWA2022 Conference

A Toolkit to Define, Achieve, and Communicate Success

Poster Abstract
The medical writer’s role should be recognized as a scientific professional collaborating with the project teams and making valuable contributions to study planning and regulatory strategy. The value of a good medical writer extends well beyond drafting documents and polishing them to be submission ready, but these contributions often goes unrecognized. Hence, AMWA formed a task force that resulted in 3 separate subgroups to better establish and provide visibility to the value of medical writing.

This subgroup is focused on the measures of success and its drivers. Success can be measured by quality, speed, and productivity, all of which are difficult to quantify for a variety of reasons. There are always many collaborators and many factors outside of the medical writer’s control that impact the overall success of a project, and a successful medical writer makes major contributions to the team’s success. This subgroup aims to empower medical writers to manage expectations with respect to timelines, quality, and best practices. To meet this goal, we leveraged the knowledge and expertise of our team to identify the best practices for adhering to timelines, working with teams, and defining key metrics for assessing quality. We are translating these ideas and best practices into a toolkit that can be downloaded and used by individual medical writers to create and implement their own processes to reduce barriers, drive continuous improvement, and demonstrate and measure productivity. 

The toolkit will provide benchmarking for standard timelines with the steps needed to complete a document, strategies for meeting and accelerating timelines, a definition of quality along with how quality can be measured, best practices for reviewers, an articulation of the balance between speed and quality, and recommendations for how to gain better team engagement. The toolkit can serve as useful reference for developing processes and managing corporate expectations.

Be a Leader! Train a Leader! Developing Influential Leadership Skills in Medical Writing

Poster Abstract
Leadership for a project or a team in medical writing is defined by skills such as influence, effective communication, integrity, accountability, and positivity. The AMWA Value of Medical Writing subgroup is creating leadership training for medical writers and managers of writers that will be available in 2023. This workstream seeks to fill an unmet need for development of the leadership skill-set and other important soft, professional interpersonal skills required by a successful medical writer leading documents and/or leading people. The leadership training plan will have 3 focus areas: 1) defining leadership for medical writers, 2) creating/seeking a conducive environment for leadership development, and 3) identifying effective communication skills and project team management strategies that promote success. Examples, scenario practice, and other group activities will be utilized to demonstrate the learning objectives. This poster will highlight the content of this proposed training. Feedback from the AMWA community on the training plan will be solicited at the poster session.

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Empowering Medical Writers – Onwards and Upwards from the Ground-breaking Learnings from the 2021 AMWA Value of Medical Writing Workstream 

Poster Abstract
In 2021, an AMWA Working Group surveyed representatives from regulatory agencies to evaluate the effect of document quality on the regulatory review process, assess awareness among document reviewers of the contribution of medical writers to the quality of regulatory documents, and identify current strengths and opportunities to optimize document quality. These interactions resulted in a ground-breaking publication as part of the AMWA Value of Medical Writing initiative. The results showed that poor document quality impedes the reviewer’s ability to provide assessment, delays the drug approval process, and can even bias reviewers against other documents from the same applicant. Importantly, the work emphasized that medical writers increase the quality of documents, make the regulatory reviewer’s job easier, and are valued and respected by Regulatory Agencies. 

These publications were very well-received by the medical writing community, and AMWA has continued this work throughout the year with continued contact with Regulatory Agencies and the production of a toolkit to help medical writers to address these problems and deliver high quality, streamlined documents that make the scientific rationale clear. The toolkit aims to help medical writers to further improve document quality, and to help medical writing managers to develop and support their medical writers as leaders of document authoring teams.

This poster outlines the work of the Regulatory Authority Contact Working Group this year, and explains the process and production of the toolkit.

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