Santen

Company Description

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world. 

PURPOSE OF ROLE

This Position is responsible for overseeing Compliance-related duties that contribute to the sustainable and sound growth of the company and the achievement of the Vision from the following two perspectives:

• Protect the brand value of Santen by recognizing risks from a compliance perspective and responding appropriately to ensure that they are reasonable from the perspective of social common sense and corporate ethics
• Contribute to the achievement of Santen's Vision by providing timely and appropriate advice and proposals to business activities from a compliance perspective, thereby supporting them to maximize their results and profits

In pursuing its responsibilities, this Position would carry two basic missions as follows:

• Global Compliance: Assist in the achievement of the Group's overall vision by contributing to a solid global compliance foundation through the proposal of specific measures and steady implementation in collaboration with regional compliance departments
• Region / Japan Compliance: Provide support and guidance to compliance management department in Japan, to help them continue to strengthen the appropriate organizational management system and compliance functions to protect the business promotion of the Japan business from compliance risks

Job Description

Strategic Planning

• In the Global perspective, understand the direction of our business development, plan and propose global measures in terms of compliance in order to realize appropriate risk management based on the business and geographical expansion of new characteristics and realize them together with the regional compliance department
• In the Regional guidance perspective with focus to Japan, closely work with leadership and compliance team in Japan to realize compliance management by recognizing risks from a local compliance perspective, making reasonable proposals and advice based on local business strategies and from the perspective of local laws, regulations and social norms. Examples include Proactive Compliance Measures, Annual Needs Assessments, Whistleblower Data, Auditing and Monitoring results, Risk Assessments based on General and Specific Risks/laws, Policy Development and Trainings

Contribution to Financial Performance

• Prevent compliance risks and promptly resolve issues that have emerged, thereby reducing expenses due to litigation and penalties, business losses, and decline in corporate value
• Contribute to the company's profits by maximizing results by supporting the implementation of optimal domestic and global business activities from a compliance perspective

In-house Business and Process Renovation

• Strive to provide services globally through current processes, process improvements where necessary, reporting, communications, and system utilization to promote efficient operations
• Clarify the roles and responsibilities of domestic compliance operations and establish an optimal organizational management system for domestic compliance management that can provide prompt and high-quality compliance reviews and consulting.

Enhancement in Organizational Strength through Revamp and Learning

• Contribute to the global and local systems/processes that comply with the latest laws, codes, and industry rules, to improve the Company's compliance level based on the benchmarks of other companies through training, reporting, consultations, internal and external activities, etc.
• As the compliance supervisory department, share knowledge and experience through collaboration, communication and cooperation, to improve organizational strength
• Contribute to the business by supporting the rapid provision of optimal solutions in order to maximize the results of internal clients
• Provide effective compliance training and educational tools by contributing to a systematic compliance education and training system

Qualifications

• B.A. or B.S. degree required, J.D. preferred
• 10+ years of experience serving in a compliance, legal, regulatory or related role in the pharmaceutical/medical device industry required
• In-depth knowledge and understanding of pharmaceutical industry laws, regulations and guidelines
• Thorough functional knowledge of the elements of a pharmaceutical/device compliance program and thorough knowledge and understanding of the pharmaceutical/device industry
• Demonstrated ability to identify, assess, and prioritize higher risks versus lower risks
• Demonstrated ability to take gray areas/ambiguity in the laws/regulations or complex new areas and provide recommended courses of action to senior management
• Demonstrated project management skills and proven experience partnering with cross functional teams
• Strong business partner with a focus on collaboration and delivering results
• Excellent written and verbal communication skills, with the ability to persuade others/change behavior across various levels in the organization
• Japan and English speaking preferred

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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