Angela Russell Winnier, PhD and Julia Forjanic Klapproth, PhD / Clinical Development and Operations Medical Writing, Pfizer, New York City, NY; Trilogy Writing and Consulting (an lndegene Company), Frankfurt, Germany

Abstract

The AMWA Educational Workshop Leadership Development for Medical Writers is an annual conference offering aimed at equipping medical writers with critical leadership skills amid evolving landscapes. The workshop is designed to address the gap in training programs for medical writers that traditionally focus on technical skills by fostering the leadership qualities necessary to drive projects and effectively manage change within teams and organizations. Overall, the workshop aims to develop the ability to lead as a medical writer (either with or without official reporting line authority) and to inspire teams to achieve common goals and navigate organizational changes successfully. This initiative is vital in preparing medical writers to meet the dynamic demands of the industry and contribute significantly to their organizations’ success.

Overview

At AMWA’s 2019 Medical Writing & Communication Conference, the AMWA Executive Forum, which includes leaders from across the industry, committed to defining the value of medical writing. One purpose of that work was to provide information to our members about how to defend the role of the medical writer in their organizations. Part of this effort focused on surveys to regulators and medical writers about document quality and medical writing value.’·² Accompanying the survey publications, an article about how to optimize medical writing value was also prepared.3 1he survey data have been presented at previous meetings for both AMWA and Drug Information Association. This article summarizes the content of a leadership train-ing workshop that followed the optimizing value work-stream. Colleagues from 7 companies worked together to create this material (Pfizer, Bristol Myers Squibb, Parexel International, Jazz Pharmaceuticals, Janssen Research and Development, Trilogy Writing and Consulting, and Amgen; see Acknowledgments). The workshop has been part of the annual AMWA conference educational workshop offerings since 2023.

The need for this training arose from the recognition that, although we all agree that influential leadership and other soft skills are important for medical writers, most of our in-house training programs focus on bringing writers to the technical level required of the work. There was little training being offered to develop the leadership skills we know writers need for success. Until recently, we have done a lot of work to understand core competencies of medical writers, and most of the training programs have focused on the technical or knowledge-based skills considered as part of these core competencies.⁴•5 Soft skills like leadership skills have been underemphasized, yet we know from the surveys cited previously and personal experience that leadership is essential for medical writers to do their job well. In our article about how to optimize medical writing value, we looked at what employers were looking for in prospective medical writers. A review of job advertisements for medical writers found that the top soft skills sought were for leadership and team working.3 This correlates with what we learned that regulators value in medical writers and with what medical writers said they were most often valued for: leadership and collaboration skills.1•2 In a time of breakneck speed trans-formations in technology, leadership development is even more essential for those leading the charge for evaluation, implementation, and adoption of these tools.

The AMWA Leadership Development for Medical Writers Workshop offers a 3-hour interactive overview of the top leadership behaviors identified by tl1e Value of Medical Writing Workstream. Offered annually, the workshop aims to equip medical writers with essential leadership skills to drive projects and navigate organizational (including technological) change effectively within their teams and organizations.

The workshop begins by highlighting the significance of leadership in medical writing, especially as the industry faces rapid technological advancements. Key learning objectives include defining leadership skills necessary for managing change, identifying first steps for leadership training, understanding elements of a conducive training environment, and recognizing behaviors to become influential leaders. 1he workshop stresses the importance of effective communication, establishing authority and presence, and managing stakeholders during transitions (like during the adoption of a new technology tool). In the sections that follow, we will summarize the main topics covered by this educational offering.

Leadership Qualities and Characteristics

Leadership in medical writing is multifaceted. It involves guiding project teams through successful document crafting, review, and completion, leading process improvement teams to new technological solutions, and mentoring colleagues in skill development. Being a role model who can inspire teams to achieve their goals amid constant scope flux or other distractions is essential. Therefore, being a leader in medical writing is not just about being a people manager; it is also being able to lead our teams without official reporting line authority. Influencing others to work together to achieve a common goal is a superpower that our industry should be developing in parallel with the more technical skills that we typically emphasize in the development of our teammates.

The workshop outlines essential qualities that define a good leader, which are especially pertinent when managing any new change, whether related to new regulatory guidance, business restructuring, or technology adoption:

• Integrity: leaders must have strong moral principles and honesty to build trust during transitions.
• Vision: leaders should have a clear vision of the goals a team is working toward and how to achieve those.
• Positive attitude: essential for creating a sense of pur-pose and building morale.
• Sense of humor: helps teams to bond and handle the stress associated with projects they work on together.
• Communication: effective leaders are solid communicators who can articulate the benefits and challenges of their common purpose.
• Inspiration: leaders must inspire their team to embrace and excel on the mission they have been assigned.

For example, as medical writers face technological changes, their leadership in this transition is crucial. They must have a clear vision of how technology can improve their team’s performance, communicate effectively about the benefits and challenges of new technologies, and inspire their teams to embrace these advancements.

Creating (and Finding!) The Stretch Challenges That Lead to Growth

Managers play a crucial role in fostering a supportive envi-ronment that inspires leadership development. They must encourage transparency, provide learning opportunities, and support their teams in overcoming challenges associated with their roles.

A fantastic book by Liz Wiseman walks through the accidental behaviors of leaders that may stunt the growth of emerging leaders.6 This book introduces the concept of “multipliers” and “accidental diminishers” in management. In the workshop, we highlight how to be a multiplier, that is, a leader who optimizes their team’s potential by trusting that teammates will figure it out if given room to do so. Many well-meaning managers jump to rescue rather than enable their team. In doing so, they unknowingly become accidental diminishers; this behavior leads to dependence on the manager, weakening problem-solving skills and independence. In the workshop, we challenge people managers to give their teammates a “mission impossible” task that will stretch them, offering learning and development along the path. We similarly challenge writers, as they grow their leadership muscles, to seek and accept such impossible-sounding tasks. After all, growth and discomfort often coexist! Encouraging and seeking growth through stretch challenges and proposing those intriguing questions lead to a culture of courage and curiosity. Learning to tap into the team’s natural giftedness is also a way for a group to exceed expectations.

Safe Training Environments, Generalized Training, and Effective Communication

In the workshop, we emphasize the need for a safe environ-ment in which team members feel comfortable taking risks and learning from mistakes. Leaders should share their own mistakes to create a culture of transparency. This is particularly important in our current age of artificial intelligence transformation as we explore, experiment, and implement supportive technologies and associated behavioral and process changes.

The value of offering generalized training is also high-lighted, referencing David Epstein’s book Range: Why Generalists Triumph in a Specialized World.7 Regulatory writers are trained as generalists; they have gained experience across drug development phases and document types and are better equipped to apply their skills flexibly to new situations, leading to creative problem-solving and influential leadership.

In addition to developing these skills through on-the-job experience, formal training of people in leadership roles can expedite their development by making them aware of common leadership mistakes and giving them tools and ideas to overcome these. Effective training programs that encourage broad experiences and stretch goals are linked to higher employee satisfaction.3 Robust mentoring programs supporting the growth of new leaders, especially as they adapt to changing regulatory requirements and technological advancements, are essential. We recognize that not all organizations can offer the same level of training, but making people aware of the core tenets of good leadership concepts can aid anyone who needs to apply these ideas, and we encourage participants to build in and apply these ideas when applicable in their professional endeavors.

Finally, effective communication is key, particularly during times of major change. Leaders should share their passion, plans, and appreciation with their teams. The workshop highlights the importance of active listening, providing constructive feedback, and using humor to build rapport and ease flexible adoption of changing environmental conditions.

Influential Leaders Masters These Key Soft Skills

For writers to develop into influential leaders, whether on their project teams or on initiatives or as people managers, they need to increase their visibility and presence, even in virtual settings. In the workshop, we provide tips for effec-tive virtual communication and highlight the importance of being assertive, clear, and confident-all essential leadership behaviors when leading teams through change and those impossible-seeming challenges.

Understanding and managing stakeholders is critical for leadership success, whether working on a project or as a manager. We emphasize the importance of building relationships, understanding team members’ strengths, and aligning their work with the team’s goals in the context of new expectations or regulatory requirements or even the use of new technology. Being capable of reframing the challenge in question into opportunity, while also knowing and addressing the concerns of the team, is a superpower. Often, the writer can pivot the team from panic to peace. Establishing the influence to inspire that transformation is one of the topics emphasized in the workshop.

Ultimately, being capable of managing the room starts with managing ourselves. Self-awareness and emotional intelligence are essential for effective leadership. Emerging leaders learn to recognize and manage their emotions, understand others’ emotions, and practice self-care to maintain peak performance. A discussion of the elements of peak performance (spoiler: not just technical proficiency!) is provided in the workshop, with tips for maximizing success through key personal and professional habits.

The workshop concludes with a focus on the role of leaders as role models. We emphasize the importance of setting a positive example, respecting all contributions, and encouraging a healthy work-life balance. By empowering teams and fostering a supportive environment, leaders drive success and innovation in medical writing, including with the opportunities presented by new technologies.

Conclusion

In summary, having recognized that leadership and collab-oration are top soft skills sought by employers and valued by regulators, a leadership training concept was developed to better equip medical writers to meet this need. The AMWA Educational Workshop Leadership Development for Medical Writers provides insights into developing leadership skills for medical writers and offers advice for management styles and strategies to support this development. By embracing these principles, medical writers can enhance their professional growth and contribute significantly to the value of medical writing within the industry, especially as they manage transformative change.

Acknowledgment

Microsoft Copilot was used as a supportive technology for development of the outline and the abstract, based on the workshop content. Many thanks to the contributions in 2021-2022 from the following collaborators for the workshop materials (showing their organizational affiliations at the time of the collaboration): Angela Winnier,1 Renee Primus,2 Linda Yih,3 Amy Myers,4 Nika Matze,5 Julia Forjanic Klapproth,6 Amy Compton,7 and Karen Garman3 (!Clinical Development and Operations Medical Writing, Pfizer, New York City, NY, ²Global Scientific and Regulatory Documentation, Bristol Myers Squibb, Princeton, NJ, 3Medical Writing Services, Parexel International LLC, 4Medical Writing, Jazz Pharmaceuticals, Palo Alto, CA, 5Regulatory Medical Writing, Janssen Research & Development, Raritan, NJ, 6Trilogy Writing and Consulting, Frankfurt, Germany, 7Regulatory Writing, Amgen, Thousand Oaks, CA).

Author declaration and disclosures: The authors note no commercial associations that may pose a conflict of interest in relation to this article.

Author contact: angela.r.winnier@pfizer.com

References

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• 2. Harris D, Tyrrell C, Myers A, Carr C, Fink KL. Value of medical writing: the regulatory writer’s perspective. Am Med Writ Assoc J. 2021;36(4):152-158. doi:10.55752/ amwa.2021.85
• 3. Harris D, James LC, Klapproth JF, Bass B, Winnier AR. Optimizing the value of regulatory medical writers. Am Med Writ Assoc J. 2021;36(4):138-144. doi:10.55752/amwa.2021.82
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• 5. Clemow DB, Wagner B, Marshallsay C, et al. Medical writing competency model-section 2: knowledge, skills, abilities, and behaviors. Ther Innov Regul Sci. 2018;52(1):78-88.
• 6. Wiseman L. Multipliers, Revised and Updated: How the Best Leaders Make Everyone Smarter. HarperCollins; 2017.
• 7. Epstein D. Range: Why Generalists Triumph in a Specialized World. Riverhead Books; 2019.