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Director, EU Compliance Operations

Raptor Pharmaceuticals

Location:
Novato, CA
Posted Date:
7/31/2014
Position Type:
Full time
Job Code:
DirEUCompliance
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Compliance,

Job Description

Summary Description
Reporting to the Vice President, Chief Compliance Officer, the Director, EU Compliance Operations is responsible for oversight of daily European operations of healthcare compliance-related activities in support of the Company’s Comprehensive Compliance Program.  This person will serve as a subject matter expert for country-specific healthcare compliance laws and regulation in Europe and various other territories outside of the Americas in which Raptor has ongoing or planned business operations. Immediate focus will be on implementation of company policies, compliance training, ongoing monitoring of EU operations and third-party compliance due diligence.

This position will be initially located in the US with frequent travel to the EU. This is a unique opportunity to play a key role in the construction, implementation and scaling of Compliance Program within a growing organization.

Responsibilities
•Create and maintain a country-by-country compliance regulation matrix for organization
•Partner with country managers in the implementation of compliance training for all EU employees and contractors
•Conduct compliance monitoring of EU systems, medical conferences and field activity
•Oversee compliance corrective actions for EU operations
•Provide strategic input on EU patient advocacy efforts, early access programs, named patient sales, and advisory boards
•Drive EU policy drafting and implementation efforts
•Manage transparency reporting requirements for EU countries as needed (e.g., France)
•Assist in obtaining and sustaining Safe Harbor certifications for data sharing between EU and US sites
•Conduct compliance due diligence activities for third-parties in the EU
•Assess and propose systems enhancements and drive process improvements
•Provide dashboard reports as needed to executive management to help assess and mitigate risks
•Liaise with internal and external legal counsel to help enforce contracting processes
•Conduct industry benchmarking of company compliance mechanisms
•Other duties as assigned.

Requirements

•Education: 4-year degree in science, business, or law required; advanced degree a plus
•Experience: 8+ years in the Biotech, Pharmaceutical or Medical Device industry; 3+ years in an international healthcare compliance-related role
•Comfortable delivering presentations in multiple cultural environments
•Proficient in MS Office applications and on-line training tools
•Excellent written and verbal communication skills
•Ability to track, analyze and interpret complex industry laws and regulations
•Strong time management and organization skills
•Monitoring/auditing experience a plus
•Fluent in German or French a plus
•Highly collaborative, and persuasive when necessary
•Ability to travel up to 75%

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