About The Position
The Head Compliance will handle all compliance issues and develop and implement the Compliance program at European level and in Canada. With direct responsibility for the compliance teams in the CEE region and Canada, the Compliance Director will take full ownership of the field of ethics and compliance within these countries.
They will be responsible for ensuring that Medison and its partners adhere to regulatory requirements, both national and international, as required by local regulation and law. They will ensure full adherence to standards, policies and procedures. They will also be responsible for adhering to internal policy, ensuring that the organization holds internal inspections to prevent lapse in control and regulation.
The Compliance Director is a member of the CEE& Canada leadership team, reporting to Head of International markets.
- Develop and implement compliance policies and SOPs
- Train, audit and monitor activities to ensure an effective compliance program within the CEE&Canada
- Develop and deliver training and education programs for all employees on compliance policies and the legal and regulatory framework
- Provide advice and guidance to management and employees on compliance related issues
- Work with all relevant business areas to develop and implement corrective actions plans identified through compliance monitoring and auditing activities
- Oversee regulatory and business driven compliance strategy, promoting a culture of compliance based on company’s values and Code of Conduct
- Provide compliance and risk mitigation plan
- Lead the Compliance teams in CEE and Canada
- Implementation of the Compliance Program, including strategic risk management, global and local standards, compliance governance, monitoring and investigations
- Provide strategic direction and compliance leadership to the region
- Actively participate and serve on regional leadership teams, providing compliance guidance consistent with the Company’s culture and values to promote ethical behavior, and enhance the Medison global compliance program
- Lead, drive, and conduct proactive compliance initiatives such as risk assessments, compliance workshops, training initiatives, and other compliance monitoring activities
- Develop, implement, and manage compliance programs, processes, and systems to mitigate compliance risks
- Identify opportunities for growth and enhancement of the Medison global compliance program
- Partner with regional colleagues and countries leadership teams under your scope to maintain and further develop throughout the organization a strong culture of compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving
- Draft and/or update appropriate policies to ensure compliance with applicable laws, regulations and industry codes and alignment with global policies
- Support the implementation and maintenance of affiliates transparency reporting requirements and assist business leadership in meeting reporting obligations
- Assist in implementation and execution of regional and local risk based third party due diligence
- Support investigations into allegations of misconduct, as required
- Degree in law, finance, business, or a related discipline
- Solid experience and proven track record in the pharmaceutical compliance sector.
- Possess an exceptional knowledge of pharmaceutical industry laws, guidelines and codes.
- Successful track record of building a culture of compliance and ethics.
- Experience dealing with government agencies and other regulatory and/or enforcement bodies.
- Fluent in English.
- Experience working in small-to mid-size pharmaceutical companies in the start-up phase is a plus.
- Strong knowledge of healthcare compliance and the applicable legal and regulatory framework especially within the EU/CEE.
- Excellent interpersonal skills and ability to successfully maintain professional and trusting relationships. Strong communication and presentation skills.
- Strong focus on detail are also essential
- Works effectively in highly dynamic and changing environment
- Displays agility.
- Multi-geographic experience preferred
- High sense of ethics and integrity