Head of Compliance, Europe

Reposted 2 Days Ago
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Basel, Basel-Stadt
In-Office
Senior level
Biotech
The Role
Lead compliance for BeOne's operations in Europe, develop compliance programs, advise on regulations, and foster a culture of integrity.
Summary Generated by Built In

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 an experienced compliance leader in Europe. As a key member of the Legal and Compliance function, this is an excellent opportunity to lead a team and support the launch of new BeOne therapies and the Company’s rapid business growth in Europe. The position will contribute to the development and implementation of organizational strategies, policies and practices, and work with senior Commercial, Medical, Clinical Development, Legal, Finance / Internal Audit and HR leadership to integrate appropriate healthcare, corporate and other compliance controls to guide the Company’s operations. 

Responsibilities:

  • Lead continuous development of Healthcare Compliance Programs in Europe in line with BeOne’s global compliance strategy, the OIG Compliance Program Guidance for Pharmaceutical Manufactures (OIG Guidance), applicable industry codes and best practices; Collaborate with cross-regions and implement global compliance initiatives in Europe.

  • Proactively identify legal and regulatory issues, industry trends, industry codes and practices applicable to compliance; Advise on the adoption of new, or revision of existing, policies and procedures to ensure compliance with laws, regulations and applicable industry codes globally and regionally.

  • Develop and monitor the execution of a comprehensive compliance training program for Europe employees and designated third parties on applicable compliance policies, laws and regulations.

  • Foster a culture of compliance and integrity in the region; Institute and maintain effective compliance communication channels for the Company by promoting awareness and retention of the Code of Conduct, the use of the Compliance Helpline, as well as other means for employees to report compliance-related concerns or engage with senior leadership.

  • Provide compliance leadership and oversight for review and approval processes for core Commercial and Medical activities: grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations government officials / entities, and patient advocacy groups.

  • Provide healthcare compliance subject matter expertise in the development of appropriate systems, tools and technology solutions to enhance the efficiency and effectiveness of the Healthcare Compliance Program relating to common HCP interactions, such as advisory boards, consulting engagements, speaker programs, sponsorships and grants.

  • Collaborate with the Global Compliance Program Office and Internal Audit on the design and execution of internal reviews, risk assessments, monitoring and auditing to ensure that compliance policies and procedures function as intended and the Company identifies potential compliance risks and remediates where necessary.

  • Support Global Compliance Program Office in the conduct and resolution of compliance investigations as needed, including the implementation of corrective and preventive actions plans.

  • Establish and chair the Compliance Committee in Europe; Provide regular compliance related reports and other communications for multiple audiences in the Company, including the Compliance Committee, Commercial Leadership, Medical Affairs teams, country management teams, and the Board of Directors.

Supervisory Responsibilities: Yes

Other Qualifications and Experience:

  • Minimum of 12 years’ relevant experience including in-house pharmaceutical experience developing compliance programs.

  • Leadership experience and skills; Minimum of 5 years’ people management experience; Experience in supervising dotted-line reports is desired.

  • Extensive experience with compliance matters relating to the development, approval and commercialization of pharmaceutical products.  Ideal candidate will have been a Compliance Officer in Europe at a global oncology or hematology company.

  • Comprehensive knowledge of healthcare fraud and abuse laws and transparency requirements as well as industry codes in European countries.

  • Ability to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations.

  • Strong critical thinking skills, attention to detail, adaptability, communication skills and professionalism.

  • Ability to work in a matrix organization, collaborate with business partners, influence peers and interact with both senior management and Field Force, Medical and Market Access teams.

  • Ability to manage and serve a wide range of client groups by recognizing and responding quickly and pragmatically to urgent situations.

  • Exceptional and demonstrated written and verbal communication skills and interpersonal skills in both one-on-one and group settings, as well as proven negotiation skills.

  • Excellent organizational skills and problem-solving capabilities and the ability to perform in a fast-paced, high volume, deadline-driven environment.

  • Confidence to advise stakeholders at all levels.

  • Appropriate judgment to liaise with Legal and business colleagues and/or outside counsel as needed.

  • Commitment to being a team player with the desire to be helpful in other areas covered by a growing Compliance department.

Travel:  

Travel approximately 10%, primarily in Europe.   

This position requires travel to maintain a high level of visibility with field teams, leadership and general presence at Company events (e.g., scientific conferences, national and regional plan of action meetings).

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.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

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.

Top Skills

Healthcare Compliance Programs
Regulatory Compliance Systems
Training Programs
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The Company
HQ: Cambridge, MA
2,862 Employees
Year Founded: 2010

What We Do

BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 8,500 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
See our community guidelines: bit.ly/39o3O6j

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