Compliance Specialist EPM

Description

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.

As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live.

Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.

We are a dynamic, fast-paced company, operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us!

Reporting to the regional Compliance Director, EPM/HQ, the Compliance Specialist, EPM, will be responsible to execute and manage the EPM region’s Monitoring Program activities as part of the Compliance Program, including provide Compliance support for the healthcare compliance audits. Furthermore, as part of the Monitoring activities and the related outcomes, the person will be responsible for and will collaborate closely with the stakeholders such as the Cluster Compliance Officers and the Business for the potential Monitoring Findings, Deviations and related enhancements/corrective actions plans and the tracking/successful completion of it.

In addition, the Compliance Specialist will be supporting the EPM Compliance Team with the efforts on managing, maintaining, sustaining and implementing an effective ethics and compliance program, processes, and systems to mitigate compliance risks within the designated area of responsibility. 

This, with a risk-based approach and a focus on the ongoing enhancement for an effective compliance program.

Furthermore, the Compliance Specialist will be promoting and advancing an ethical culture within the organization and the cross-functional teams and serves as a role model with high ethics and integrity.

The Compliance Specialist will be applying the corporate compliance standards in line with applicable (global, regional and local) laws and regulations and healthcare best practices industry standards.

Supports the efforts of the EPM Compliance Club Community.

This position will also participate, or lead global, regional and local projects as needed.

Responsibilities

• Ensures adherence to applicable laws, regulations and standards
• Works closely with the cross-functional key stakeholders such as Medical, Commercial, Finance and Legal teams.
• Promotes and fosters a culture of compliance, ethics and integrity.
• Responsible to execute and manage the EPM region’s Monitoring activities as part of the Compliance Program, including provide Compliance support for the healthcare compliance audits.
• Participates to, or leads global, regional and local projects as needed.
• Supports the efforts of the EPM Compliance Club Community.
• Participate/lead applicable ethics and compliance initiatives as needed.
• Provides support to the EPM Compliance team with the management of the compliance program, processes, and systems to mitigate compliance risks as needed.
• Identify opportunities for growth and enhancement of the Medison global compliance program, partners with regional colleagues and countries teams under the scope to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving and can-do approach.
• As needed and as necessary, draft and/or update appropriate guidelines to ensure compliance with applicable laws, regulations and industry codes and alignment with global policies.

Requirements

• University degree, such as in law, finance, business, medical, data management and analytics or equal
• Minimum of 5 years’ experience in the healthcare life sciences sector with a minimum of 5 years’ experience in a compliance function.
• Possesses in depth knowledge of applicable healthcare laws, anti-bribery and anti-corruption laws such as U.S. FCPA, OECD Convention, UK Bribery Act etc., guidelines, and best practices codes.
• Successful track record of building a culture of compliance and ethics.
• Knowledgeable in Compliance for the region which includes Europe, CIS countries and if possible, MEA.
• Any other regions, countries is a plus.
• Fluent in English – written and verbal is a must.
• Positive and can-do attitude
• Able to encourage and lead cooperation between functions
• Has a start-up mind set, sets the right priorities and focus
• Is comfortable with ambiguity and anticipates
• Manages well complexity, has a holistic view and big picture thinking
• Change Manager
• Self-management, proactive, works independently
• Is a team player, motivates
• Manages well work life balance, keeps the energy high
• Is a natural learner, eager to learn, curious personality
• High ethical and compliance values
• High interpersonal skills
• Effective communication and excellent presentation skills

Brings business acumen