- Develops, implements, and revises Company compliance policies.
- Responsible for designing and implementing the Company's transparency reporting capabilities to ensure compliance with the Sunshine Act and state disclosure laws.
- Utilizes extensive healthcare compliance experience to help business teams achieve their strategic goals while navigating the complex US regulatory environment.
- Responsible for designing and implementing the Company's compliance auditing and monitoring program.
- Partners with the General Counsel/Compliance Officer to ensure business alignment with the Company's compliance program through the Company's Compliance Committee.
- Oversees the company's healthcare compliance training program, including its e-learning platform.
- Partners with the business team and provides practical, solution-oriented advice to advance the Company's interests.
- Creates an open and transparent environment in which individuals can team together to drive optimal outcomes.
- Develops creative solutions to compliance challenges by working closely as a business partner.
- Provides advice and guidance for the accomplishment of the overall business objectives in compliance with applicable laws and regulations affecting the company and pharmaceutical industry.
- Partners with business team to support overall business and growth strategy of the company while providing practical compliance advice relating to applicable laws and regulations.
- Provides high quality, timely and practical compliance advice, and guidance; identifies and resolves critical compliance and business issues arising from regulatory, clinical, medical affairs, sales and marketing, human resources.
- Designs, implements, and manages the Company's transparency reporting capabilities.
- Ensures that the strategy, structure, and processes for the area(s) managed is aligned with regional and corporate business strategies, as well as market strategies.
- Creates an open and transparent environment in which individuals can team together to drive optimal outcomes.
- Promotes a culture of compliance by fostering an environment of open and honest communication with all employees of all levels; reinforces the importance of conducting oneself in an ethical manner and in the best interests of the company.
- Provides practical, real-world compliance training to enable business teams.
- Establishes and maintains strong relationships with all levels of management, company compliance officers and business teams as a trusted advisor on legal and compliance matters.
- Collaborates with outside law firms to draft and prepare policies.
- Bachelor's degree or higher required; advanced degree and/or healthcare compliance certification preferred.
- 10+ years' experience with compliance requirements in the biotechnology or pharmaceutical industry required.
- Experience working with all levels of management and key business stakeholders; proven success influencing outcomes and effectively communicating compliance risks to executive leadership and senior management.
- Experience advising on and excellent knowledge and experience with laws and regulations governing the pharmaceutical industry, including FDA, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, HIPAA, GDPR and such.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Mathematical skills needed for budgeting and financial responsibilities.
- Excellent communication skills (verbal and written) and the ability to create and make informative and persuasive presentations to internal team members, company executive leaders/stakeholders, and external parties.
- Great leadership qualities including experience managing cross-functional legal teams, as well as sound business and legal judgment, and strategic and analytical thinking.
- Work is generally sedentary in nature but may require standing, walking, grasping, and lifting/moving up to 15 pounds.
- The noise level in the work environment is usually quiet.
- Minimal business travel.
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Senior Director, Compliance - Cambridge, United States - ONO PHARMA USA
Description
Key role that supports and provides advice on a broad range of matters for the Company's clinical development, commercial, medical, and corporate healthcare compliance matters.
Planning and Execution
Financial Outcome
Operation and Improvement
Innovation
Talent Development and Organization Growth
External/Internal Relationship
Educational Requirements
Experience
Technical Skills
Cognitive Skills
Language/Interpersonal Skills
Other
Physical Demands
Work Environment
Business Travel
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role. (US Only)
