We are experiencing one year revenue growth of 29% and seven year revenue growth of 1500%.
Job Description: Director of U.S. Compliance
Reporting to the Chief Compliance Officer, the Director, Corporate
Compliance-Global R&D will have a significant role in the design
and development of the corporate compliance program for research and
development, quality, safety and manufacturing practices.
Responsibilities will include the development of written policies
and procedures, training and education, communication, monitoring and
reporting plans and investigations/corrective actions.
This position will work closely with the R&D and operational
groups, providing both compliance oversight and support to their
operations. The position will also coordinate with the international
compliance officer supporting these business areas.
Responsibilities: Director of US Compliance
• Develop and execute a plan for development of R&D policies,
SOPs, guidance, etc. based on prioritized needs in coordination with
Global Compliance and other functions
• Act as the point of contact for R&D on all compliance-related issues
• Identify priority areas for the development and implementation of an
international, risk-based compliance monitoring and auditing program
R&D
• Lead the development, communication and implementation of all R&D policies and SOPs
• Document Management: Organize the storage and document management of:
- Policies and SOPs,
- Affiliate policies and SOPs
- R&D documentation and records
- Promotional materials
• Subject matter responsibility for:
- Data Protection and Patient Privacy
- Intellectual Property compliance
- Pharmacovigilance/Drug Safety
- Product Recalls and Complaints
- GXP
- Assist with global training efforts
Qualifications: Director of US Compliance
- 5-7 years R&D experience
- Prior experience within pharmaceutical, biotechnical or healthcare compliance
- Ability to communicate and work with many disciplines, such as
management, scientists, physicians, information systems specialist,
state, federal and international agency officials and others
- Ability to apply management and leadership skills to attain and maintain compliance in a cost-effective manner
- Education: MD or Pharm.D. preferred
If you are in the Philadelphia area and interested in learning more about the Director of U.S. Compliance job opening, click here to send an email with your resume.
