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Phillips Esq.
Phillips Esq., Attorney-at-Law
Category: Employment Law
Satisfied Customers: 12934
Experience:  B.A.; M.B.A.; J.D.
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I am a regulatory affairs professional and my current position

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I am a regulatory affairs professional and my current position of 3 months poses significant risk to my career. I was placed by a large staffing agency at a nonprofit research organization with a for profit division (see details below). Initially, I was reporting to the "Chief Compliance Officer," who I discovered was also conducting business development and raised the issue to the Officers in the Company and the staffing agency. A change in reporting structure resulted and I'm now reporting to the CFO. I should note that the previous RA/QA Manager left after working with the organization for nearly 20 years.

This organization is providing regulated services in a CRO capacity to a pharmaceutical company, who is conducting a Phase 3 clinical study for registration of their product - FDA approval.

Regulatory requirements and my professional advice are actively ignored and shunned, and the fact is that there is no organizational recognition of this fact and no desire to document anything or conduct business in good faith.

I notified the staffing agency, the recruiter told me that I am on my own and if I want to resign from this potentially career damaging situation, that's on me. *In accepting this position, I was never made aware of the fact that this company is providing critical regulatory services: electronic data capture, clinical data management and statistical design and output - i.e. the clinical study outcomes: safety and efficacy for FDA approval of the pharma client's drug product.

It's been 4 weeks since I had this frank discussion with the staffing organization. I've worked 50-60 hours per week and even thought my contract states I may charge overtime, the company will not allow me to charge anything over 40 hours. Again, I feel that signing my name to anything right now has the potential to damage my regulatory career of 13 years and the stress is damaging my health.

I'm without support and need legal advice as to how I should proceed. I am inclined to submit 2 weeks notice but I'm then jobless; the staffing agency clearly understands this but my statement of this fact has put me in further isolation. Another note, this is an organization is severely understaffed in the regulatory and quality departments: 1 regulatory affairs and quality assurance staff member: me, a contractor of 3 months. The stress is too much, I cannot take a day off, I'm asked to work weekends and obliged, which is on me but the ramifications of not working are significant.

I know this is a lot and it's the abbreviated version: what is my best course of immediate action?
Submitted: 10 months ago.
Category: Employment Law
Expert:  Phillips Esq. replied 10 months ago.
Hello: This is PhillipsEsq. I am a licensed Attorney and I will be assisting you today.


I am sorry to read about your difficulties. Your options are quite limited here. If you do not want to be unemployed for a while or cannot afford to be unemployed at all, then you need to take your time in finding another suitable employment before quitting this one. As you know, if you quit, you would not be eligible for unemployment compensation. Have you considered asking the staffing company to look for a comparable position for you elsewhere? Then, when you get the new job, you can give your current employer a notice of your resignation.

So, you may consider postponing giving your notice of resignation until you have accepted another job offer and has a specific start date. Otherwise, you may find yourself with no job for quite a long time and with no unemployment benefits.


Let me know if you need additional information.

Customer: replied 10 months ago.

The staffing agency and the company have a 6 month contract, they need cause to violate the contract. I will ask the staffing company to place me elsewhere and I'm actively interviewing for other positions.


 


In the meantime, I am signing my name and reputation to 21 CFR Part 11 documents and other documentation that is open to FDA inspection should the pharma client succeed in gaining approval of this drug.


 


There are ongoing fraudulent activities, misrepresentation and more.... I am in a legal and ethical decision making process.


 


Any further advice? I have an employment attorney and can proceed with her.

Expert:  Phillips Esq. replied 10 months ago.

The staffing agency and the company have a 6 month contract, they need cause to violate the contract. I will ask the staffing company to place me elsewhere and I'm actively interviewing for other positions.

In the meantime, I am signing my name and reputation to 21 CFR Part 11 documents and other documentation that is open to FDA inspection should the pharma client succeed in gaining approval of this drug.

There are ongoing fraudulent activities, misrepresentation and more.... I am in a legal and ethical decision making process.

Any further advice? I have an employment attorney and can proceed with her.

Response: If you are being asked to do something illegal, you should not do it. However, to protect yourself, you should file complaint with the regulatory authority—with the FDA. After doing that, you can give your notice of resignation and actually state the reason for your resignation. You are doing this to make sure that you would be eligible for unemployment benefits. Generally, if you voluntarily leave you job, you would not be eligible for unemployment benefits. However, if you are forced to quit, if you are being asked to do something that is questionable on a daily basis, it is most likely that you would be eligible for unemployment benefits under that circumstance.

Customer: replied 10 months ago.

Thank you; that's the answer.

Expert:  Phillips Esq. replied 10 months ago.
You are quite Welcome!


All the best
Phillips Esq., Attorney-at-Law
Category: Employment Law
Satisfied Customers: 12934
Experience: B.A.; M.B.A.; J.D.
Phillips Esq. and 4 other Employment Law Specialists are ready to help you

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