Pharmaceutical Compliance Consultant
See more projectsIntensity
5hr/week
Est. Duration
3months
Location
Remote
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
5 years
Time On Graphite
2
Hiring Managers