Compliance Manager – Transparency
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Job Description
Compliance Manager for Summit Therapeutics managing transparency reporting and compliance activities across healthcare providers and organizations. Enhancing corporate compliance program with stakeholders' collaboration and adherence to regulations.
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, auditing 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 or her designee.
- 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 Chief Compliance Officer or her designee 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.
Requirements:
- Bachelor's degree required (preferably finance, business or law); advanced degree preferred.
- Must have a minimum of 6+ years of progressively responsible experience in a healthcare related compliance role, preferably with a pharmaceutical company.
- CCEP certification is a plus
- In-depth knowledge of state and federal regulations related to HCP/HCO spend reporting, tracking and registration for pharmaceutical manufacturers
- 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)
- Exceptional analytical ability and problem-solving skills.
- 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.
Benefits:
- Competitive salary
- Bonus opportunities
- Health insurance
- Flexible working arrangements
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