Compliance Manager, Transparency

Summit Therapeutics•Princeton, NJ

4d•$10 - $20

About The Position

The Compliance Manager, Transparency, is responsible for the monitoring and reconciliation of transactions to ensure data is accurate and compliant with the Sunshine Act, the company’s policies and procedures related to reportable transfers of value, and other applicable law. The Compliance Manager, Transparency is also responsible for the successful close-out of activities, ensuring financial, transparency and compliance accuracy of all costs and activity associated with events as required by federal and state government reporting and regulations.

Requirements

Bachelor's degree or Advanced degree
Must have 6+ years of progressively responsible experience in a healthcare related compliance role, preferably with a pharmaceutical company.
Advanced knowledge in Excel, proficient in Power Point, Word, Outlook and SAP is required.
Knowledge of finance and accounting practices.
Strong knowledge of key laws and regulations impacting the medical device or life science industry (e.g., AKS, Sunshine Act)
Excellent written and oral communication skills; ability to work effectively and efficiently with all levels of management and personnel
Strong organizational and planning skills and meticulous attention to detail
Self-starter with the ability to work independently as well as collaboratively in a team environment
Ability to handle competing priorities in a fast-paced environment and exercise sound commercial and legal judgment
Must be flexible due to rapidly changing business environment for a growth company

Nice To Haves

CCEP certification is a plus

Responsibilities

Support the company’s transparency reporting activities in accordance with all applicable laws and company policies for Healthcare Providers (HCPs) and Healthcare organizations (HCOs)
Ensure correct reporting for all Transfers of Value (TOV) from the company to the reportable HCPs and support HCP dispute resolutions.
Achieve transparency monthly, quarterly, and annual reporting deadlines with accurately reported data as well as conduct weekly data scrubbing for submission into the reporting system.
Maintain up-to-date knowledge of Sunshine Act transparency reporting requirements to assess general data quality issues that may impact ability to report information to the applicable agencies.
Resource for day-to-day processes related to compliance with Sunshine Act Transparency, analyze and determine the best course of action for each inquiry/problem, while producing timely reports and providing supporting documentation for audits.
Support the implementation of transparency monitoring policies and procedures and training on them.
Provide support in the annual certification process.
Partner with multiple stakeholders throughout the Company (e.g., Legal, Clinical Operations, Medical Affairs, Sales and Marketing, HR, Internal Audit, QA) to manage and enhance an effective corporate compliance program and function and ensure that appropriate compliance policies, procedures, and internal controls are in place
Develop, maintain and regularly assess key policies and procedures to mitigate identified risks and meet government and healthcare compliance requirements
Ensure curriculum and training plans align with business needs and regulatory/legal requirements
Understand relevant laws and regulations in key global markets to ensure that the Company’s policies and business practices align with such laws and regulations
Assist with monitoring and enforcement of compliance efforts, including compliance monitoring activities; risk assessments and reviews of compliance risk areas to determine risk exposure; ongoing collaboration with key stakeholders to identify any issues of non-compliance; and summarize and report same to the Chief Compliance Officer and Head of Compliance
Conduct and manage compliance investigations regarding allegations of law or company policy or ethical standards and prepare written reports on the findings of such investigations, as directed by the Chief Compliance Officer or her designee. Assist with the determination and implementation of corrective actions
Collaborate with the Head of Compliance and global team to continue to enhance a culture of ethics and compliance
Serve as a resource and subject matter expert for all healthcare compliance related activities
Lead on other projects as assigned from time to time
All other duties as assigned