Our President, Michael Larkins, weighs in on the importance of Life Science workforce compliance when scaling post-FDA approval.
When the FDA fast-tracks a therapy, it sets off a chain reaction. Research and development timelines accelerate. Trial phases overlap. Regulatory teams shift into overdrive. And suddenly, companies must scale fast without cutting corners.
For life sciences organizations, this presents both incredible opportunity and serious operational risk. The challenge isn’t just about finding talent quickly. It’s about scaling strategically with the right processes, documentation and compliance safeguards in place.
Urgency After FDA Approval
Once a product is greenlit or fast-tracked by the FDA, the organization typically enters a hyper-growth phase. Teams must expand rapidly to accommodate the next stage of development, launch planning or distribution. Critical functions such as regulatory affairs, clinical operations, pharmacovigilance and manufacturing often require immediate staffing reinforcement.
But hiring full-time employees for every need isn’t always realistic especially when timelines are uncertain or talent demands are niche. That’s why companies are increasingly turning to Statement of Work (SOW) contracts and Independent Contractors (ICs) to bridge the gap. The flexibility and speed these models provide are invaluable but only if implemented with the proper compliance framework.
The Risks of Moving Too Fast Without a Workforce Plan
Speed is crucial, but it can’t come at the cost of compliance. Without a thoughtful approach to workforce expansion, companies open themselves up to significant risk. The most common pitfalls include:
- Worker misclassification: Treating an IC like an employee can violate labor laws.
- Poor SOW documentation: Vague or incomplete scopes can lead to scope creep, missed milestones or budget overruns.
- Unverified contractors: Engaging ICs without proper vetting may compromise both legal standing and project quality.
In a highly regulated industry like life sciences, these errors aren’t just costly, they can jeopardize your product’s timeline, trigger audits and damage your company’s reputation.
What’s at Stake?
The U.S. Department of Labor and IRS have tightened scrutiny around independent contractor classification. In 2023, the DOL reinstated the “economic reality” test, making it more difficult for companies to classify workers as ICs. Meanwhile, state-level agencies continue to pursue aggressive enforcement.
Companies that misclassify contractors can face stiff penalties, including:
- Back wages and benefits
- Tax liabilities
- Fines and legal fees
- Reputational damage with investors and regulators
In the life sciences sector, where product delays can cost millions and lives are at stake, any misstep in workforce compliance can have outsized consequences.
The Role of SOW and IC Compliance in High-Growth Environments
When done right, SOW and IC engagements enable life sciences companies to scale quickly, tap into hard-to-find expertise and remain agile, all while staying within legal boundaries.
For SOWs, best practices include:
- Clear deliverables: Define exactly what’s being delivered and by when.
- Milestones and timelines: Provide structure and accountability for both sides.
- Fixed pricing or outcome-based compensation: Helps maintain budget control.
For IC compliance, ensure:
- Independent contractor vetting: Evaluate work history, business licensing, insurance and independence from direction/control.
- Proper documentation: Contracts, onboarding materials and communications should reflect the non-employee relationship.
- Ongoing oversight: Track engagements, monitor scope creep and ensure independence is maintained throughout the contract.
These proactive steps reduce misclassification risk and empower your teams to operate at the pace required by fast-tracked drug programs.
Post-Approval Growth Without the Guesswork
FDA fast-tracking is a powerful accelerant. But acceleration without structure leads to chaos. The organizations best positioned to succeed post-approval are those with flexible, compliant workforce strategies in place before the pressure hits.
That includes:
- Engaging SOW teams for time-bound projects like regulatory submission or post-market surveillance.
- Bringing in independent experts for specialized consulting roles without long-term hiring commitments.
- Ensuring real-time visibility into your extended workforce so you can adjust in real time as your clinical or commercialization phases evolve.
By building a repeatable, compliant approach to SOW and IC engagements, life sciences workforce compliance can move faster with fewer delays, less risk and better outcomes.
How SWM Can Help
At Suna Workforce Management (SWM), we specialize in helping life sciences organizations scale smart. We offer:
- Independent Contractor compliance assessments
- SOW strategy and project documentation support
- Centralized workforce visibility tools
- Flexible staffing solutions tailored for clinical, regulatory and commercial needs
Our clients rely on us to not only find the right talent but to ensure every engagement is structured to withstand regulatory scrutiny.
The future of life sciences staffing isn’t just about who you hire, it’s about how. Fast-tracking may open doors, but only a compliant, scalable workforce plan will get your innovation across the finish line.
Don’t wait until problems arise to build your strategy for life sciences workforce compliance solutions. The time to prepare is now.