Compliant AI Governance For Medical Affairs

Introducing The Medical Affairs Artificial Intelligence Playbook

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Note that each sample page is from a different section of the Playbook (they are not consecutive)

About the Playbook

The Medical Affairs Artificial Intelligence Playbook is an operating Playbook for compliantly integrating AI into Medical Affairs work. It addresses a specific gap. Most published guidance on AI productivity was written for general business work. Medical Affairs operates under constraints that general business work does not have. On-label discipline. Fair balance. Off-label boundaries. Medical, Regulatory, and Compliance review. Cross-functional scope between Medical Affairs and commercial, sales, clinical development, regulatory, and market access. The Playbook is calibrated to those constraints because the prompts were built by someone who has navigated them.

Who the Playbook is for

Medical Science Liaisons. Those who make up the largest segment of Medical Affairs. Pre-call planning, follow-up after scientific engagement, KOL profiling, insight sentiment analysis, and the broader work of field medical execution are core to the Playbook.

Medical Directors and Medical Affairs Leadership. The strategic and operational planning prompts (territory planning, advisory board planning, launch planning, congress planning) and the upward-facing communication prompts (leadership dashboards, budget narratives, cross-functional briefings) are calibrated to senior contributors who own this work.

Medical Communications, Medical Information, and Publications Professionals. The standard response letter drafting, FAQ development, slide deck planning, and MRC review preparation prompts address the production work of medical communications, including both the reviewer perspective and the author perspective on the regulated review process.

Regional Field Directors and MSL Directors. The dashboard, cross-functional briefing, team goals development, and status update prompts cover the work of managing field medical teams across territories.

The Playbook is most useful to professionals who already work in Medical Affairs and want to integrate AI into the work they already do. It is not designed for AI generalists who happen to be applying their skills to Medical Affairs from outside the function.

Who the Playbook is NOT for:
If you work in a function outside Medical Affairs, the Playbook will not serve you well. The constraints, the workflows, and the audience are specific to Medical Affairs. Commercial professionals, clinical development professionals, and regulatory professionals have their own constraints that this Playbook does not address.

If your company has not approved any AI tool for your use, the Playbook is not actionable for you yet. The prompts assume you have access to at least one approved tool. Buy the Playbook when your company catches up if you want, but do not buy it expecting it to bypass your company’s AI policy.

If you are looking for general AI productivity advice rather than Medical Affairs specifics, there are better resources for that, most of them free. The Playbook’s value is in the specificity to our field, not in general AI competence.

The 43 Prompts at a Glance

From the Playbook, each prompt can be easily copied and pasted into your approved workplace AI. Just follow the guidance in the Playbook on what to upload and customize based on your specific needs.

KOL Engagement and Field Interactions
1. Pre-Call Planning
2. Follow Up Email after Scientific Engagement
3. Follow Up Email after Advisory Board
4. KOL Profiling and Mapping
5. KOL Segmentation
6. Finding New Conversation Topics for Repeat KOL Meetings
7. Cold Outreach to KOL
8. Finding New KOLs
9. Answering a Complex Scientific Question

Scientific Exchange and Data Mastery
10. Evaluating a Scientific Publication
11. Preparing to Deliver a Clinical Data Presentation
12. Learning a New Therapeutic Area or Disease State
13. Building or Updating a Personal Scientific Knowledge Base
14. Preparing a Journal Club Discussion
15. Synthesizing Multiple Publications on One Topic

Insights, Intelligence, and Synthesis
16. KOL Insight Sentiment Analysis
17. Keeping Up With Competitor Scientific Data and Positioning
18. Synthesizing Insights for Cross-Functional Partners against the Medical Strategy
19. Identifying Unmet Medical Needs and Scientific Data Gaps from Field Insights
20. Competitive Landscape Shifts Analysis

Daily Workflow and Communications Management
21. Email and Teams Triage Plus Thread Summarization
22. Drafting Responses to Internal Messages
23. Meeting Prep Triage Plus Synthesis
24. Status Update for Individual Contributors
25. Status Update Roll-up for Managers and Project Leads

Internal Communications and Leadership
26. Monthly or Quarterly Leadership Dashboard
27. Cross-Functional Briefing for Internal Partners
28. Preparing for an Internal Stakeholder Talk
29. Developing SMART Goals for the Team
30. Budget Narrative and Justification

Medical Communications and Materials
31. Standard Response Letter Drafting
32. FAQ Document Development
33. Scientific Slide Deck Planning and Structure Development
34. MRC/PRC Review Preparation, Reviewer Perspective
35. Medical Material Development for MLR Submission, Author Perspective

Strategy, Planning, and Operations
36. MSL Territory Planning
37. Advisory Board Planning
38. New Product Launch Planning
39. Congress Planning and Execution

Cross-Functional and Stakeholder Work
40. Evaluating KOL Contribution to a Working Group or Advisory Board
41. Responding to Internal Requests for KOL Recommendations
42. Drafting Input to Clinical Development on Investigator and Site Identification
43. Drafting Input to Market Access on Payer Credible KOL Engagement

Each prompt includes the use case, the prompt itself, the inputs to gather before running it, the constraint language that addresses specific failure modes, an example output to calibrate expectations, and the failure modes to watch for after the AI produces output.

Inside the Playbook

What makes the Playbook different?

The constraint language in every prompt. Medical Affairs work has specific failure modes (off-label drift, fair balance gaps, promotional language, scope creep across functions) that generic AI guidance does not address. Each prompt encodes the constraints that prevent these failure modes from appearing in the output.

The verification flagging convention. External-facing prompts instruct the AI to add [VERIFY AGAINST LABEL] at the end of any sentence that requires label verification before the output is used. The convention turns the AI’s limitation (it does not know your label) into a structured handoff to the human reviewer.

The foundations chapter. Before any of the 43 prompts, the Playbook addresses what you need to know about using AI in Medical Affairs without getting it wrong. Five failure modes. What the AI knows and does not know about your product. Document upload as a best practice technique. Saving prompts and reference materials for repeated use.

The prompt engineering primer. The Playbook closes with a teaching chapter on writing your own prompts for workflows the Playbook does not cover. The primer teaches the patterns that produce Medical Affairs prompts rather than generic ones.

The Playbook is the Jumping Off Point

You have been AI trained. You have done a couple of pilots. You occasionally use AI to summarize an article. Now what?

The 43 prompts give individuals and teams substantive material to begin integrating AI into actual Medical Affairs work. The architecture is sound, the constraint language is calibrated, and the prompts produce output that survives the standards Medical Affairs operates under. For an individual contributor or a small team working independently, the Playbook may be enough.

For teams looking to integrate AI across the function, more work is required. A shared prompt library that team members actually use, not three different versions of similar prompts sitting in three different documents. A governance framework that aligns AI use with compliance, IT, legal, and the regulatory environment your organization operates in. Learning loops that translate individual AI experience into team intelligence rather than letting insights stay siloed in individual contributors’ work. A measurement approach that connects AI work to the medical strategy and priorities the function is accountable for, so leadership can evaluate whether the investment is producing results.

This is where Triple Helix Strategy comes in

Triple Helix Strategy is the Medical Affairs and AI consulting practice built around the same work the Playbook represents. These fundamentals are applied directly to the organizations and teams that hire us. The Playbook is the published version of how we think about this. The consulting engagement is where the thinking gets translated into the operating model and specific strategies your organization uses.

Engagement types include:
– Strategic advisement to senior Medical Affairs leadership exploring where AI fits in the function’s evolution
– Operational work building the prompt libraries and AI governance frameworks that translate capability into actual productivity
– Training programs calibrated to Medical Affairs work specifically and tailored to your team’s current capabilities
– One-on-one coaching for individual leaders navigating the AI shift in their roles or within their teams.

The Playbook works as a standalone product. Organizations that find the Playbook useful and want to extend the work to their full function are encouraged to reach out.

What the Playbook does NOT do

The Playbook DOES NOT substitute for an approved AI tool. It assumes you have access to at least one tool that has been approved by your company’s IT and compliance teams.

The Playbook DOES NOT eliminate compliance risk. The prompts reduce specific failure modes but the user remains accountable for every output produced. The Playbook is explicit about this throughout.

The Playbook DOES NOT address every workflow Medical Affairs does. The 43 prompts cover the most common and highest-leverage workflows. The prompt engineering primer teaches the patterns for extending the Playbook to workflows which are not covered.

The Playbook IS NOT a substitute for your professional expertise. It is a tool that makes Medical Affairs expertise more efficient and more consistent across teams.

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<- Click for Playbook FAQs

My company has not approved an AI tool yet. Will the playbook help me?
Not until your company approves a tool. The playbook is starting material for AI work; it does not substitute for having an approved AI tool to use it with. If you anticipate approval in the near future, the playbook is worth purchasing now so you are ready when the tool is available. If approval is years away or unlikely, wait.

My company’s AI use policy is restrictive. Are the prompts still useful?
In most cases, yes. The prompts are designed to work with text input and text output, which is the lowest-friction AI use case and the one most restrictive policies still permit. The document upload technique described in the foundations chapter is policy-dependent, and the playbook is explicit that you must verify what your company permits before uploading any document.

Does using AI in Medical Affairs create new compliance risk?
It can, if done without the appropriate frameworks. The playbook is designed to reduce compliance risk by including constraint language in every prompt that addresses the specific failure modes that affect Medical Affairs work: off-label drift, fair balance gaps, promotional language, scope creep across functions. The verification flagging convention in external-facing prompts ensures that every claim requiring label verification is flagged for review before the output is used. The playbook does not eliminate compliance risk. You are still accountable for what you produce. But the playbook reduces the failure modes that occur when AI is used without Medical Affairs specific guidance.

What if I cannot upload documents to my AI tool?
The prompts default to paste-based workflows. Where document upload would improve output, the playbook describes it as a pro tip rather than a requirement. The vast majority of the prompts are useful without any upload capability.

What if AI tools change and the playbook becomes outdated?
Your purchase includes updates for 12 months from the purchase date. AI tools evolve rapidly and so does our understanding of how to use them well in Medical Affairs. Prompts will be added across the update period including prompts shaped by buyer feedback. The playbook is a living product, not a static document.

Can I just figure this out on my own?
You can, and many Medical Affairs professionals have. The question is how long it takes and how much trial and error you accept along the way. The playbook condenses 25 plus years of Medical Affairs experience and substantial work on AI integration into 43 prompts you can use immediately. The math on whether $399 is worth the time saved is yours to do.

Can I get an invoice to include on my expense report?
Yes! Send a request with the order number to support@triplehelixstrategy.com

Have an idea for a prompt? Submit it here for consideration in future Playbook versions.

Have questions or need assistance with your Playbook? Email support@triplehelixstrategy.com

<- Author Bio

Dr. Paul Minne, PharmD, RPh has spent nearly 30 years in Medical Affairs across multiple therapeutic areas, several biotech companies, and several product launches. Paul is passionate about training others. He is an adjunct faculty member at the University of Colorado Skaggs School of Pharmacy and built a highly successful postdoctoral fellowship program in partnership with the University of Southern California School of Pharmacy.

The Playbook reflects what Paul has learned about working with AI in Medical Affairs and what he teaches Medical Affairs professionals about integrating AI into regulated field and functional work.