Compliance Manager

Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across Israel ,Europe, Americas and ANZ helping to save and improve the lives of patients suffering from the most challenging diseases.

Medison has deep expertise in local regulatory and market access know-how with uncompromising compliance excellence. It offers an affiliate-like partnership and tailored solutions for country-specific and regional commercialization, enabling emerging biotech companies to navigate local complexities and expand their reach to patients in Central Eastern Europe.

Reporting to the Compliance Director, the Risk Manager will oversee the compliance risk management program, assessing and identifying risks that could damage the company's reputation regarding anti-bribery and corruption.

The position will be responsible for conducting internal audits and leading external audits. He/she will enhance global and regional compliance standards and support the continued development and implementation of Medison’s compliance program and ethical behavior.

The Risk Manager must have excellent quantitative and analytical skills, along with the ability to apply those skills across a variety of business processes.

The Risk Manager will be responsible for ensuring that Medison and its partners accede to regulatory requirements, both national and international, as required by local regulation and law. He/she will ensure full adherence to standards, policies, and procedures. He/she will also be responsible for enhancing internal policies. Some international travel will be required.

Responsibilities

Risk Assessment

• Develop communicate, and ensure implementation of global guidelines and processes for assessing and remediating compliance risk for all operations with touchpoints with healthcare professionals, high risk third party engagements, or government officials.
• Collaborate with local compliance officers and other functions to continuously monitor trends and changes in the external environment, such as enforcement action or new laws, and promote and refresh policies, training, or other elements of the compliance program.
• Identify and act on internal risks and gaps in compliance program effectiveness. Devise/ advise global mitigation and corrective actions.
• Manage risk-based compliance programs (based on internal and external data) for relevant partners and/or vendors. Ensure appropriate mitigations based on the assigned risk level

Internal& Partners Audits

• Support and lead all internal and external compliance audits, including the main focal point for communication with auditors and internal business partners
• Ensure all relevant information and documents are available for effective audits.
• Responsible for carrying out reviews and assessments of compliance clearance activities across the Company.
• Test the extent to which business is and remains demonstrably compliant
• Providing advice and guidance to the business on necessary corrective and preventive actions to achieve improved compliance,
• Reporting to compliance management and other relevant functions on levels of compliance assurance and/or any issues arising from monitoring/external/internal.

Requirements

• Degree in finance or economics
• Possess an exceptional knowledge of pharmaceutical industry laws, guidelines, and codes-an advantage.
• Strong communication and presentation skills as well as a focus on detail are also essential.
• Successful track record of building a culture of compliance and ethics
• Fluent English – written and verbal is a prerequisite

Required qualification

• Analytical skills and Commercial Awareness
• Planning and organizational skills
• Ability to understand broader business issues.
• P&L management knowledge and experience together with an excellent grasp of economics
• Ability to influence senior stakeholders internally and externally.
• Open to give & receive feedback
• Interested in continuous learning
• Self-management & proactive
• High ethical and compliance standards
• Excellent interpersonal & presentation skills
• Ability to lead and implement change
• Able to encourage and lead cooperation between functions
• Managing complexity (across brands, markets, functions)
• Building, engaging, and leading high-performance teams