Attracting great talent can be a hurdle for start-up companies. Life science entrepreneurs know that finding and retaining top talent is crucial to the success of their fledgling company. Not only does the right talent help ensure that the work gets done properly, having top talent on your team is likely to generate approval from investors and board members and has the potential to assist you with obtaining future funding. In Part 1 of this series, we discussed that start-up life science companies need to have a position/role. In Part 2, we’ll discuss the importance of the applicant review process.
A clearly defined applicant review process provides a way for life science companies to demonstrate that they are meeting the regulatory expectation for ensuring that the talent that they bring on to the team is qualified to perform their role and meet the regulatory requirements.
Wait… there are regulatory considerations for hiring personnel?
Yes! There are regulatory considerations beyond those related to employment law.
The Principles of ICH GCP, as defined in the ICH E6 guideline states:
Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). This statement applies to anyone who is going to be anyone “involved” in the development, execution or oversight of a clinical study.
21 CRF 211.25 (part of the US GMP regulations) specifies “Personnel qualifications” applicable to individuals engaged in the “manufacture, processing, packing, or holding of a drug product” and to individuals supervising these activities. Specifically, personnel must have the education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions”.
What is the best way for my company to comply with these regulations?
1. Have a detailed position description (see part 1 of this blog series)
2. Obtain a resume or CV from each candidate
3. Interview the candidate
4. Ask for references and perform reference checks
5. Run a background check to confirm that the information the candidate furnished on their resume/CV is accurate and to ensure that the candidate does not appear within the:
6. Ensure that there is a process for documenting that all of these steps have taken place. Generally, regulatory authorities take the stance: “if it wasn’t documented, it didn’t happen”.
Surely, these requirements don’t apply to contractors, does it?
Yes. Regardless of whether the personnel are employees or contractors, companies are responsible for ensuring that personnel are qualified for their roles.
Stay tuned for the next installment in this series: A Start-up Leader’s Guide to Recruiting Top Talent - Part 3: 3 Tips for Engaging a Professional Recruiting Service Provider Who Understands Life Science Start-ups