An industry leading pharmaceutical company in the Greater Boston area is looking to hire a Senior Manager, Compliance Monitoring to lead the monitoring efforts for the company's Ethics & Compliance business unit.
Responsibilities
- This position will lead Ethics & Compliance efforts to establish, manage and enhance the Compliance Monitoring program
- Develop and implement policies, procedures and processes to establish the Compliance Monitoring Program
- Develop annual desktop and live monitoring plans in areas such as: risk assessment outputs, previous monitoring results, business activities, sample sizes, etc.
- Conduct desktop and live monitoring on a quarterly basis and report summary and detailed results for leadership review
- Lead business group's understanding, development, and implementation of remediation/corrective action plans that address monitoring findings or other audit findings
- Provide leadership and individual contribution to the company's E&C Monitoring program
- Lead global discussions relating to monitoring execution results, data collection and reporting, presentations, problem resolution, etc.
- Manage monitoring files and records, ensuring files are maintained in accordance with Record Retention schedules
Experience
- 6+ years of legal, compliance or commercial experience, of which at least 3 years in the healthcare or pharmaceutical industry;
- Bachelor's degree required; JD or relevant advanced degree preferred
- Solid understanding of state and federal health care laws/regulations
- Experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, healthcare standard operating procedures, and anti-bribery laws.
