Pharmaceutical Compliance Consultant
See more projectsIntensity
5hr/week
Est. Duration
3months
Work Remotely
Work from your own location. No travel is required to apply to this project.
Schedule Expectations
Expert can manage their own schedule
Communication Expectations
(None Provided)
Project Overview
8 to 15 years professional experience
Operations - Compliance and risk
-An innovative company in the clinical trials space is looking for a consultant to lead a project dealing with HIPAA compliance. The company operates a database of millions of electronic medical records and has these on file for when their clients, large pharma sponsors, want to conduct clinical trials.
-Looking for a consultant to manage the compliance side of their operations. The consultant will maintain & update SOP, documentation, and HIPAA compliance.
-The consultant will need to have working knowledge of all this documentation for instances such as when a large pharma customer wants to audit them. The consultant will be expected to pull data and answer questions regarding it.
-Strong working knowledge of HIPAA is a necessity, and GDPR is a “nice to have”.
-The consultant also should have decent working knowledge from a healthcare IT perspective (SOPs around security systems, patients, etc.)
***The engagement will start at around 5 hours/week, but will gradually ramp up over time. It is expected that in the near future it will ramp up to around 20 hours/week and the engagement is expected to go much longer than 3 months.
-Looking for a consultant to manage the compliance side of their operations. The consultant will maintain & update SOP, documentation, and HIPAA compliance.
-The consultant will need to have working knowledge of all this documentation for instances such as when a large pharma customer wants to audit them. The consultant will be expected to pull data and answer questions regarding it.
-Strong working knowledge of HIPAA is a necessity, and GDPR is a “nice to have”.
-The consultant also should have decent working knowledge from a healthcare IT perspective (SOPs around security systems, patients, etc.)
***The engagement will start at around 5 hours/week, but will gradually ramp up over time. It is expected that in the near future it will ramp up to around 20 hours/week and the engagement is expected to go much longer than 3 months.
Additional Notes
Prior big pharma experience, experience at contract research organization, and prior healthcare experience. Preferred Background
Sector Experience
Life Sciences & Pharma
Preferred Skills and Certifications
Functional
Compliance and risk
About The Client
Top Skills Hiring For
Compliance and risk
6 years
Time On Graphite
2
Hiring Managers