Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website

https://www.us.sumitomo-pharma.com

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director, Compliance. This Director will be part of the compliance team and collaborate with internal and external stakeholders and partners to ensure compliance with various business activities and will specialize in global Spend Transparency and compliance reporting. This position will lead the development, implementation, and ongoing management of global healthcare transparency and disclosure requirements and will ensure timely and accurate reporting of data. The ideal candidate must have deep expertise and demonstrated leadership in transparency regulations, data governance, cross-functional collaboration, and compliance operations. The compliance professional must be a team player and be able to work in a highly collaborative environment.

Job Duties and Responsibilities

Own and manage global transparency reporting program, ensuring compliance with all applicable spend disclosure and reporting laws and regulations
Lead the execution of transparency reporting in the U.S. and globally, as applicable, including establishing and delivering periodic program-related updates and communications
Establish, maintain, and evolve policies, processes, and systems to enable accurate and timely data capture, validation, and reporting
Oversee and directly manage the collection, integration, and transformation of data from multiple internal and external sources
Partner with internal and external partners/vendors to implement and/or enhance systems supporting transparency reporting
Serve as the subject matter expert on transparency regulations and communicate updates and impacts to stakeholders across the business to ensure aligned and compliant spend tracking and reporting practices and lead implementation of required changes to the transparency program as applicable
Lead the resolution of data quality issues and drive root cause analyses, remediation, and continuous improvement initiatives
Provide practical and thoughtful compliance guidance and training to stakeholders regarding compliance data capture, reporting expectations, timelines, and documentation standards.
Lead internal reviews and management sub-certification processes, including preparing and presenting transparency dashboards and metrics to stakeholders across the organization
Support SMPA’s compliance program and assist in executing plans, including conducting risk assessments, training, advising on day-to-day activities, and auditing and monitoring.
Proactively identify emerging regulatory issues, developments in industry practices, and compliance risk trends

Key Core Competencies

Strong leadership, project management, and analytical skills
Superior communication skills, especially presentation skills, writing and listening.
Ability to synthesize complex regulatory requirements into actionable business processes
Ability to work effectively at multiple levels of the organization and with diverse teams
Ability to present a solutions-based approach to risk mitigation efforts.
Ability to travel (20%)
High degree of organizational awareness, ability to connect the dots to understand all the interdependence and big picture

Education and Experience

Bachelor’s degree required
10+ years compliance experience in Pharmaceutical/Biotech industry
Demonstrated experience leading and managing U.S. and/or global Transparency reporting including interpreting regulations, designing, developing, and implementing processes, conducting audits, managing disputes, report preparation and submissions, and transparency system development and implementation
Project management experience including cross-functional coordination involving stakeholders in technology, operations, commercial, medical, finance, etc.
Compliance, audit, or operations experience in a pharmaceutical, biotech, or medical device company
Strong understanding of auditing, accounting, and financial reporting concepts
Strong knowledge of regulations and guidance related to FDA, OIG, CMS, FTC, and PhRMA
Strong knowledge of applicable laws, regulations, and guidance, including anti-kickback laws, fraud and abuse laws, anti-bribery, antitrust, privacy, and product liability

The base salary range for this role is $191,200 to $239,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Our Vision and Culture

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.

Our Mission

To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide

Our Vision

For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas

Sumitomo Pharma America, Inc. jobs

Director, Compliance

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