BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
BeOne is seeking a senior lead Compliance to support and advance BeOne’s Healthcare Compliance program in France. This position will also support regional and global teams and projects as needed. As BeOne advances its global presence, this position will require a self-starter who is comfortable working in a dynamic environment and has a pragmatic approach to identifying, managing and remediating risk.
Experience in the pharmaceutical industry is strongly desirable but comprehensive experience in heavily regulated industries and or consulting experience with pharma & biotech may also be considered.
Acting as the designated local compliance officer for France, this position is part of the senior management* in France and will be located in Paris IDF - France.
*Senior management does not automatically mean membership in the board or part of management committee per se-that discretion resides in the GM on incorporation of LT-this position is partnering with HR and senior leadership, including the PR to continue to drive the culture of compliance and ethical decision-making and will be advising leadership on tone-from-the-top and risk posture; hence irrespective of LT inclusion, the position has to demonstrate an ability to grow into a leader role.
Key Responsibilities:
Support the continued development of Company’s Healthcare Compliance Program in France consistent with the French health Law and all related regulations applicable in France, Company’s Code of Conduct and Healthcare Compliance policies, as well as applicable industry standards and best practices.
Closely work with internal teams at local and global level to identify required submissions and ensure, with internal and external support, mandatory submissions are done according to local requirements (ARS, CNOM, CNOP, transparency, etc.)
Manage the local vendor providing services on contract, submission (ARS, CNOM, CNOP), payment and transparency services.
Train teams to be able to manage the regulatory submissions and support as needed in an evolving and dynamic environment.
Provide compliance support and advise internal teams (including Regulatory, Pharmaceutical Affairs, Market Access, Marketing, Sales, Medical, Corporate Affairs and Clinical) on local projects and events/engagements involving HCPs/HCOs and a broad array of healthcare compliance matters, including antibribery and anticorruption, interpretation of company policies, communications about Company products, and interactions with healthcare professionals, healthcare organizations, patients, and government entities.
Implementation and oversight of ABAC controls aligned with Sapin II - this includes proactive risk mapping and third-party due diligence processes.
Monitoring of high-risk activities (consulting agreements, sponsorships, grants).
Closely support and implement the EU and global compliance team programs.
Closely work with global team to implement internal monitoring plan (*where needed, conduct internal reviews, risk assessments, monitoring and auditing) to ensure that compliance policies and procedures function are correctly applied as intended; idendify potential compliance risks and implement plans for remediation when necessary.
Proactively identify industry trends and practices applicable to healthcare compliance; establish and advise on policies and procedures to ensure the continued effectiveness of Company’s Healthcare Compliance Program; support development of an annual France compliance risk assessment and support risk-based monitoring and audit plan.
Develop and implement comprehensive compliance training consistent with Company policies, applicable laws, and industry standards for local and global teams engaging with French HCPs and HCOs.
Regularly educate and inform the French team on matters related to the compliance program as well as relevant healthcare industry legal and compliance developments.
Represent the function when needed in any committee or other leadership platform.
Partner with internal (e.g., Pharmaceutical affairs in France, Legal, Data Privacy, Global Compliance, and Human Resources) and external (e.g., outside counsel, local Competent authorities, investigators) stakeholders for the conduct and resolution of potential compliance investigations/observations, including the management of any resulting corrective actions plans; support coordination of any speakup, engagement, and other whistleblowing mechanisms and ensure alignment with all applicable France laws including Sapin II.
Provide and maintain effective compliance communications with business partners to promote compliance awareness.
Support global and regional compliance projects on an as-needed basis, including support of commercial, medical, market access and clinical teams and activities.
Any other requirements that may be identified by Management.
Supervisory Responsibilities:
To be decided. This is a matrix set up so the individual should be fluent in ability to navigate matrix reporting and management. This means that this individual also manages liaisons and relationships autonomously and or under direction from the Management.
Salary Range France: 80,800.00 EUR - 101,000.00 EUR
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.