[Poland] Compliance Business Partner - Russia, CIS, EE

at  Santen

Company Description
As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of “Happiness with Vision” by providing valuable products and services to patients, consumers, and medical professionals around the organization.
Since its establishment in Japan in 1890, and guided by its CORE PRINCIPLE, “Tenki ni sanyo suru,” Santen has been committed to helping people maintain and improve their eye health, and is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people worldwide. Our duty is to create a future in which as many patients and consumers as possible can lead happy and fulfilling lives, we will continue to contribute to the realization of better eye care by providing solutions that eliminate bottlenecks in the diagnosis and treatment of eye diseases, thereby revolutionizing the treatment flow.
Each of us is deeply committed to challenging ourselves, building an organization that brings together diverse internal talents and external expertise, and to doing our utmost to realize a society in which people everywhere can feel happy through vision-related experiences. Isn’t it exactly the kind of environment you want to belong in?
Job Description
Compliance Business Partners are essential for overseeing our compliance operations in the local affiliate markets to ensure adherence to complex and stringent regulations governing our industry. These professionals are responsible for maintaining compliance with local, national, and international laws, including those related to marketing/medical practices, transparency laws, ABAC, HCP interactions and more. They help mitigate risks associated with non-compliance, such as hefty fines, legal liabilities, and reputational damage. Additionally, compliance professionals implement and monitor internal policies and training programs to foster a culture of ethical conduct and continuous improvement, ensuring that the company’s operations align with industry best practices and regulations. Their expertise and vigilance are critical in navigating the ever-evolving regulatory landscape, thereby protecting public health and the company’s integrity.

Compliance Business Partner will serve as the “face of Compliance”, working with the business in a given cluster, liaising with key stakeholders across the EMEA organization, including distributor markets when applies. This position is responsible for oversight of Compliance activities in Russia, CIS, EE. This role will ensure that we meet the stringent requirements of transparency on all TOVs with HCPs.

• Focused on directing and coordinating front-line engagement and compliance risk management advisory support to the business.
• Serve as a subject matter expert on compliance matters, providing guidance and support to various departments within the specified region cluster.
• Advise on compliance risks, potential issues, and mitigation strategies.
• Conduct review and approval of various interactions, engagements and contracts (e.g., HCP Engagements) across specified region cluster.
• Foster a culture of compliance. Promote a strong culture of compliance throughout the organization. Encourage ethical behavior, integrity, and accountability among employees. Implement initiatives to raise awareness and reinforce compliance standards.
• Collaborate with network of Compliance Champions to educate and support local markets to act compliantly.
• Collaborate with the Compliance team by leveraging their standards, tools and templates to support the business while relaying feedback to help in the development of those standards, tools, and templates
• Compliance Business Partners to EMEA Affiliates and Functions (Russia, CIS, EE) )
• live onsite&document monitoring
• Oversight and coordination of Compliance Champion Network (where needed)
• Approver of Medical Affairs HCP engagements approvals

Support EMEA Compliance with EMEA and global compliance initiatives, projects and execution of annual EMEA Compliance plans.

Qualifications

• Fluency in Russian&English (both written&verbal) is mandatory.
• Bachelor’s degree in a relevant field (e.g., Law, Business, Life Sciences). Advanced degree preferred.
• Minimum of 5-7 years of experience in compliance, preferably within the pharmaceutical industry.
• In-depth knowledge of European and international pharmaceutical regulations, including but not limited to EFPIA, IFPMA. Eastern Europe experience and knowledge preferred.
• Strong understanding of European and international compliance standards and guidelines related to interactions with healthcare professionals, healthcare organisations, patient organisations and third parties (e.g. distributors).
• Proven experience in developing and implementing compliance programs and strategies.
• Excellent analytical and problem-solving skills, with the ability to assess complex situations and provide practical solutions.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.

Additional Information
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, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law

• Focused on directing and coordinating front-line engagement and compliance risk management advisory support to the business.
• Serve as a subject matter expert on compliance matters, providing guidance and support to various departments within the specified region cluster.
• Advise on compliance risks, potential issues, and mitigation strategies.
• Conduct review and approval of various interactions, engagements and contracts (e.g., HCP Engagements) across specified region cluster.
• Foster a culture of compliance. Promote a strong culture of compliance throughout the organization. Encourage ethical behavior, integrity, and accountability among employees. Implement initiatives to raise awareness and reinforce compliance standards.
• Collaborate with network of Compliance Champions to educate and support local markets to act compliantly.
• Collaborate with the Compliance team by leveraging their standards, tools and templates to support the business while relaying feedback to help in the development of those standards, tools, and templates
• Compliance Business Partners to EMEA Affiliates and Functions (Russia, CIS, EE) )
• live onsite&document monitoring
• Oversight and coordination of Compliance Champion Network (where needed)
• Approver of Medical Affairs HCP engagements approval