Managing Resourcing for Your Regulatory Writing Team in the New Year

Resource planning is a critical process for organizations in the biopharma and medical device industries, particularly as they prepare for the challenges of the coming year. Efficient and effective resource planning ensures that regulatory teams are equipped with the right skills, tools, and personnel to sufficiently handle the ongoing demands of regulatory compliance and new product market launch activities.

In this blog post, we’ll explore the key resourcing considerations for regulatory writing teams to ensure organizations efficiently meet their goals and maintain high-quality standards.

1. Assessing Current and Future Workload of the Regulatory Team

Before diving into resourcing, it’s essential to assess both your current and projected workload. This involves looking at upcoming and ongoing clinical trials, regulatory submissions, and scientific publications, any changes in internal processes or requirements, as well as business acquisitions that may significantly affect scheduling and increase required deliverables.

Key Questions to Ask:

• Are there any anticipated increases in trial activity, significant manufacturing changes, regulatory filings, or new product launches?

• Are there any changes to the governing regulations or template updates that will need to be incorporated into the workflow for the coming year?

• Will you have bandwidth for unscheduled projects such as urgent regulatory agency requests, expedited submissions, or unanticipated regulatory feedback?

• What are the long-term needs for submission lifecycle management, publications, clinical safety reports, and other documents?

• Last of all, how much time is all of this expected to take?

By understanding the variables, you can better anticipate the demands on your team and whether there is a need for full-time, part-time, or freelance regulatory writers to augment your existing resources and determine if specialized skills (e.g., regulatory writing, scientific communication) will be required.

One thing to note. Submitting to regulatory bodies under pressure to meet year-end deadlines can lead a regulatory team into a dangerous cycle. Driven by corporate urgency, rushing a submission to meet these arbitrary timelines can not only compromises the quality and thoroughness of the application but can also result in being trapped in an annual submission cycle, wherein the holiday season becomes a period of constant pressure and rushed work. This not only strains the regulatory team but also increases the risk of errors, delays, and potential non-compliance, ultimately jeopardizing both product approval and the company's reputation.

2. Building a Flexible Regulatory Team

One of the top resourcing challenges in regulatory writing is the need for flexibility while maintaining quality. The demand for regulatory writing can fluctuate throughout the year, and specific expertise may be required on short notice. A flexible team, composed of both in-house and contract writers, can help ensure that you have the right skills available when needed.

Strategies for Building Flexibility:

• Trusted Contract Writers: Having a known pool of experienced regulatory writers you can rely on is essential. Contract writers can be brought on quickly for specific projects without long-term commitments and managed service providers like Global can reduce the need for extensive oversight of large teams.

• Cross-Training Teams: Ensuring that your in-house writers have the ability to handle various types of documents (e.g., regulatory writing, technical writing, manuscripts) helps distribute workloads evenly.

• Outsourcing Certain Functions: For high-volume or lower-priority tasks, outsourcing certain medical writing functions—like formatting, literature reviews, or basic editing—can free up your senior writers for more complex projects.

3. Adapting to New Technologies

The integration of advanced technologies in regulatory writing is accelerating and leveraging these tools effectively can help streamline operations. Whether it’s AI-powered writing assistants, automated formatting tools, regulatory information management systems, or project management software, adopting the right technologies can save time and reduce the risk of errors.

Technologies to Explore in 2025:

• AI and Machine Learning: Cutting edge AI can assist with initial drafts, literature reviews, and data extraction, enabling regulatory writers to focus on higher-level content creation and review. However, cutting-edge technology can bring new and often unknown challenges, some of which we will detail in a future blog post.

See how GxT’s RegWriter™ software performs End-to-End AI-augmented eCTD Module 3 and Regulatory Document Authoring and can help your team improve your authoring efficiency today

• Collaboration Tools: As remote and hybrid work environments continue to thrive, using project management software such as Asana, Smartsheet, Wrike, or Trello can help keep teams aligned and make sure deadlines are met. Collaborative authoring tools such as Veeva RIM, DocXTools, StartingPoint, Sharepoint, Egnyte, Box, and PleaseReview enable teams to work together efficiently and seamlessly on complex regulatory documents. .

• Data Analytics Software: Tools that analyze large datasets can assist medical writers in interpreting clinical trial results more effectively, improving the accuracy and clarity of their writing.

4. Investing in Continuous Training

The landscape of regulatory writing is constantly evolving. With changing regulatory requirements, new therapeutic areas, and emerging technologies, staying up to date is critical. Investing in ongoing professional development for your writing team ensures that they’re equipped with the latest knowledge and skills.

Training Opportunities to Consider:

• Regulatory Changes: Keep your team updated on evolving regulations and guidelines from agencies like the FDA or EMA, or harmonization bodies like ICH, which impact clinical trial reporting and submission documents.

• Scientific Advancements: Writers should stay informed about the latest developments in therapeutic areas and technologies relevant to your organization.

• Writing and Communication Skills: Encourage participation in workshops or courses on writing clarity, structure, and style, particularly for complex documents such as clinical study reports, Quality dossiers, or manuscripts.

See how GLOBAL's CER Essentials Course can improve your skills

5. Balancing Quality with Efficiency

In 2025, regulatory writing teams will continue to face the challenge of balancing high-quality output with the pressure to deliver on tight timelines. This often requires making trade-offs between thoroughness and speed.

Tips for Maintaining Quality While Enhancing Efficiency:

• Clear Documentation Standards: Establish clear, standardized templates and guidelines for different types of documents to streamline the writing process.

• Prioritize Core Projects: Not all tasks will have the same urgency or impact. Prioritize high-stakes or high-visibility projects while ensuring that less critical documents don’t compromise your team’s capacity.

• Review Processes: Implement an efficient review process that allows for thorough checks without missing deadlines.

• Set Appropriate Expectations: Knowing how much time a task or project should take is critical to ensure that team members are working efficiently. Set achievable deadlines and make sure team members are working on concurrent assignments to prevent delays in one project from stopping all progress.

6. Recruiting the Right Talent

As the demand for high quality regulatory writing continues to grow, attracting the right talent becomes even more crucial. The new year offers an opportunity to evaluate your current hiring strategy to ensure that you’re bringing in the right mix of expertise, whether that means hiring full-time employees, engaging freelancers, or working with comprehensive service providers.

Talent Acquisition Strategies:

• Targeted Recruitment: Focus on recruiting writers with specific expertise in areas such as regulatory affairs, scientific publishing, medical communications, and/or project management.

• Internship and Mentorship Programs: Consider offering internships or mentorship opportunities to develop new talent and build a pipeline for the future.

7. Budget Planning for Regulatory Writing Needs

Effective budgeting is essential for regulatory writing teams, especially when considering the varied costs associated with full-time employees, freelancers, and outsourcing agencies. Ensure your budget aligns with your anticipated workload, technology investments, and training programs.

Budgeting Tips:

• Flexibility in Budgeting: Allocate funds for both predictable and unexpected needs, such as urgent projects or new technology tools.

• Evaluate ROI: Continuously assess the return on investment (ROI) for outsourcing or technology adoption to ensure cost-effective decisions.

• Consider the True Costs for Outsourcing: In addition to determining the direct costs of engaging freelancers or outside agencies, it is important to also calculate the indirect costs that outsourcing can have on a team, including internal resources required to manage and review work.

• Plan for Talent Acquisition: Factor in the costs for recruiting and retaining top-tier regulatory writing talent, including salaries, benefits, and training programs.

8. Fostering a Collaborative Environment

Regulatory writing is often a team effort involving collaboration with subject matter experts, regulatory strategists, and project managers. In 2025, fostering a collaborative environment that encourages open communication and teamwork will be crucial for success.

Best Practices for Collaboration:

• Regular Communication: Ensure that writers, researchers, and regulatory experts are regularly in touch to clarify project goals and ensure alignment.

• Encourage Feedback: Constructive feedback, both from internal teams and stakeholders, helps improve the quality of written content.

• Transparent Workflow Management: A transparent workflow that includes clear timelines and expectations will help keep projects on track.

Conclusion: A Strategic Approach to Medical and Regulatory Writing in 2025

As we enter 2025, the key to successful regulatory writing resourcing lies in anticipating workload fluctuations, leveraging technology, investing in talent, and fostering collaboration across teams. By planning carefully and maintaining flexibility, your regulatory writing team will be well-positioned to handle the challenges and demands of the new year, all while ensuring the production of high-quality, compliant, and impactful regulatory documents.

Happy New Year, and here’s to achieving success through effective resourcing strategies in regulatory writing!

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