Compliance Manager, Transparency

Summit Therapeutics; Princeton (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Summit Therapeutics Inc. is seeking a Compliance Manager, Transparency, to oversee monitoring and reconciliation of transactions for Sunshine Act reporting.

The role ensures data accuracy, policy adherence, and timely close-out of activities, coordinating with Legal, Clinical Operations, Medical Affairs, Sales and Marketing, HR, Internal Audit and QA. The position requires 6+ years in healthcare compliance, CCAPCEP certification a plus, and advanced Excel skills to manage data quality and

Qualifications

• Bachelor's degree or advanced degree required.
• 6+ years of experience in healthcare compliance or related role.
• CCEP certification is a plus.

Responsibilities

• Monitor and reconcile transactions to ensure Sunshine Act compliance.
• Ensure reporting for Transfers of Value to HCPs/HCOs.
• Meet monthly, quarterly, and annual reporting deadlines with accurate data.

Skills

Excel advanced

PowerPoint

Communication skills

Attention to detail

Self-starter

Education

Bachelor's degree or Advanced degree

Tools

Excel

PowerPoint

Word

Outlook

SAP

Job description

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role:

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.

Role and 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

Experience, Education and Specialized Knowledge and Skills:

• 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.
• 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)
• 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

Pay Transparency

$10 - $20 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit Therapeutics Inc.is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.