Introduction: Expanding, Not Eliminating, Medical Writing Roles
The conversation around AI in medical writing often centers on headcount reduction—a short-term, cost-cutting approach that overlooks AI’s true potential as well as the value—often times measured intangibly through outcomes like risk reduction—that an experienced medical writer can bring to a document. Instead of focusing on shrinking teams, medical writing leaders should use AI to expand their department’s scope and strategic value.
Medical writing departments, especially in smaller companies, typically define their menu of services based on budget constraints and immediate regulatory needs; however, AI can enrich these offerings. By automating routine tasks, AI can enable teams to take on high-impact projects that were once on the “wish list” but deprioritized due to bandwidth limitations. This shift not only builds organizational value but also enhances job satisfaction and retention.
Beyond Regulatory Writing: Expanding Your Service Offerings
If your department’s primary focus has been regulatory writing—clinical study reports (CSRs), investigator brochures (IBs), and submission dossiers—AI may free up capacity to take on additional types of writing that support cross-functional teams. Here are some areas to consider:
- Nonclinical Writing
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- Nonclinical study reports and modular summaries
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- Investigational new drug (IND) and biologics license application (BLA) sections
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- Literature reviews for toxicology and pharmacology
Why it matters: Many companies struggle with nonclinical documentation because it requires niche expertise. AI can assist with structuring content while medical writers provide scientific insight and project management support.
- Pharmacovigilance (PV) Writing
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- Periodic safety update reports (PSURs) and development safety update reports (DSURs)
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- Risk management plans (RMPs)
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- Safety narratives and signal evaluation reports
Why it matters: PV teams often operate under tight deadlines, and medical writers skilled in regulatory documentation can offer much-needed support.
- Medical Communications & Publications
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- Manuscripts and abstracts
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- Congress presentations and slide decks
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- Plain language summaries of publications
Why it matters: AI-assisted drafting can accelerate content creation, enabling medical writing teams to collaborate more closely with medical affairs and publications teams.
- Internal and External Medical Writing Support
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- Standard operating procedures (SOPs) and training documents
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- AI governance frameworks for content review
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- Competitive intelligence and literature surveillance
Why it matters: Medical writers understand regulatory expectations and can ensure AI-generated content meets compliance and quality standards, which is critical as AI adoption grows.
AI as a Medical Writing Augmentation Tool, Not a Replacement
Rather than asking, “Where can we cut headcount?” the better question is:
“How can AI help us do more with the talent we have?”
AI’s Role in Expanding Medical Writing Capabilities
- Automating repetitive tasks (e.g., literature searches, formatting, citation management)
- Improving content consistency across different document types
- Enhancing collaboration by streamlining version control and document review processes
- Allowing medical writers to focus on high-value work instead of administrative burden
When medical writers are freed from time-consuming but low-impact tasks, they can engage in more strategic work that directly benefits stakeholders—whether in regulatory, medical affairs, PV, or other functions.
How to Reassess Your Menu of Services
For medical writing leaders looking to future-proof their department, now is the time to reevaluate service offerings. Consider these steps:
- Survey Cross-Functional Teams – What types of writing support do stakeholders wish they had but currently lack?
- Identify AI-Enabled Efficiencies – Which current tasks can AI help streamline, allowing bandwidth for new projects?
- Prioritize Based on Strategic Impact – Which additional writing services enhance business goals and regulatory success?
- Develop a Phased Implementation Plan – Pilot AI-driven efficiencies while training writers on expanded service areas.
- Communicate Value to Leadership – Instead of discussing AI in the context of job cuts, frame it as a tool for strengthening cross-functional collaboration and expertise.
Conclusion: AI as a Growth Opportunity for Medical Writing Departments
Medical writing teams should view AI as a catalyst for growth rather than a threat. By strategically expanding service offerings, medical writers can:
- Increase their department’s value within the organization
- Strengthen collaboration with regulatory, PV, and medical affairs teams
- Enhance job satisfaction and long-term retention
- Ensure AI adoption aligns with compliance and quality standards
AI is redefining medical writing—not by eliminating roles but by enabling teams to deliver more value than ever before. Now is the time to rethink what’s possible.
Is your medical writing department maximizing AI’s potential?
Let’s explore how AgileWriter.ai™ can help your team do more, not less. Contact us to learn more.
