MSI Pharma is partnering with a global biotherapeutics leader on a Contract Specialist role on an initial 12 month contract.
This is a collaborative role responsible for providing practical, timely, and high quality work product relating to the support of Global Clinical Development Operations (CDO). This position will support the Contract Managers across multiple studies from a contract perspective, and will act as a communicator to all relevant stakeholders in understanding the overall status of each agreement and any associated risk
- Draft, review, and negotiate agreements, including, but not limited to, clinical trial research agreements, master clinical trial research agreements, confidentiality agreements, indemnity agreements, informed consent forms, pharmacy and laboratory agreements.
- Ensures that all internal and external stakeholders adhere to established contracting and other Legal processes.
- As assigned, provide legal support in connection with contract drafting, review, and negotiation for other functions and sites.
Required Qualifications and Skills:
- Bachelor's Degree required.
- Familiarity with clinical development laws and regulations (including GCP/ICH), and health care regulations (including fraud and abuse, anti-kickback, and FDA) highly desirable.
- Experience in international contracting desirable
Start date: 10/31/2022
Location: King of Prussia, PA, USA
Full job specification(s) available upon request.
If you are interested, then please apply now! If you would like more information, then kindly drop me an email.