Head of Compliance (Europe)
Novartis
Geneva, Switzerland
vor 3 Tg.

AAA Statement

Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics.

AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company.

We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal.

Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Stellenbeschreibung

  • This role is responsible to identify proactive strategies to address potential compliance risks; ensure that activities and processes comply with all applicable laws, regulations and professional codes of conduct;
  • and assume a key role in drafting and adapting a full suite of compliance policies, guidelines and standard operating procedures.

    The Head of Compliance (Europe) will establish and maintain a proficient compliance organization across the Europe business.

    Develop a vision for AAA’s compliance program and related culture of integrity, in collaboration with AAA’s Head of Legal & Compliance and Head of Compliance (US).

    Set the direction for an aligned approach to compliance, and establish key metrics to ensure acceptable levels of adherence to internal policies.

    Actively engage in local external and internal compliance networks to shape and influence the environment and identify emerging trends / best practices.

    This is a new function within the company’s rapidly growing Europe business that faces increasing compliance obligations.

    Provide strong leadership and support for commercial decisions as the primary independent compliance advisor to Europe business.

    Deliver nuanced advice that fairly balances the achievement of business goals with the need to ensure compliance with company policies, laws and regulations.

    Assist senior management in defining the company’s general risk tolerance approach; conduct risk assessments and provide compliance advice consistent with the general approach.

    Establish a strategy for dealing with the Novartis Corporate Integrity Agreement.

    Implementation of internal compliance review : Work with AAA’s Head of Legal & Compliance and Head of Compliance (US) to implement the recommendations of AAA’s internal compliance review.

    Build a robust compliance program, including the establishment of a governance structure, monitoring activities and associate training.

    Work with external advisors to adapt Novartis policies for AAA on the following topics : anti-bribery and anti-corruption for third parties, conflicts of interest, misconduct reporting, data privacy, promotional and non-

    promotional materials, events and professional meetings, HCP and HCO engagement, Transparency, external funding (grants, contributions, sponsorships), interactions with patient organizations and transparency reporting.

    Conduct retrospective reviews as necessary.

    Chair a cross-functional Europe compliance committee to drive the compliance program along with Europe management. Provide regular updates to and ensure that issues are resolved by the compliance committee.

    Serve as the appointed compliance member on internal governance boards. Evaluate and provide recommendations to ensure AAA has an adequate compliance structure and sufficient resources to address business activities and related risks.

    Ensure strength, effectiveness, and appropriate skills of compliance committee, as applicable.

    Establish a comprehensive, periodic compliance training program across the entire Europe organization to establish, embed and enforce AAA’s compliance road map.

    Provide current information to the business on known and foreseen internal and external compliance processes to proactively guide and adjust business initiatives.

    Advocate for the importance of compliance by sharing effective, timely and relevant information on compliance trends. Perpetuate a tone at the top that reflects AAA’s commitment to ethical and legal business conduct, and compliance with the letter and spirit of the law in all aspects of the company’s operations.

    Lead counsel on transparency reporting obligations : Manage team (comprising accounting, marketing & sales, and medical affairs associates) to ensure complete reporting of payments to HCPs and HCOs for all Europe transactions in scope for transparency reporting.

    Draft, implement and monitor a comprehensive SOP governing all internal processes for transparency reporting in Europe. Optimize internal reporting systems such as AX, Veeva and notification procedures for applicable contracts, and make continuous process improvements and system recommendations.

    Conduct data reviews and prepare, review and submit annual local transparency reports for all HCP / HCO consulting arrangements, advisory boards, speakership engagements and promotional interactions.

    Ensure all state-based requirements to register medical representatives are implemented.

    Mindestanforderungen

  • Juris Doctor or equivalent degree required.
  • Bachelors Degree or equivalent required (training in biopharmaceutical science preferred).
  • Admission to a Swiss Bar or French Bar required.
  • Fluency in English
  • At least 7+ years practicing healthcare compliance law / healthcare regulatory law at a major law firm and / or life science company.
  • Comprehensive knowledge of the pharmaceutical regulatory environment : Health law, Sunshine Act (and state / local variants), EFPIA code of conduct, HIPAA / GDPR, False Claims Act, Anti-
  • corruption laws in Europe (including UK Bribery Act, Loi Sapin 2 etc)

  • In depth understanding of pharmaceutical operations, manufacturing, marketing and sales
  • Excellent interpersonal skills and ability to develop trusting relationships with stakeholders
  • Strong partnering skills to identify and leverage knowledge across the organization
  • Exceptional analytical / reasoning, problem solving, organizational and multi-tasking skills
  • Strong policy, process and project management skills
  • Outstanding presentation skills and executive presence
  • Experience developing content and delivering quality education programs
  • Demonstrated ability to establish strong external networks and relationships with experts in the field, industry peers and regulatory authorities to remain current on compliance and other industry-related trends
  • Demonstrated ability to prepare and deliver analytical, written and oral communications appropriate for multiple audiences and levels within the organization
  • Demonstrated track record of partnering with business to establish a common vision to enhancing business performance
  • Ability to manage and influence across a cross-functional matrix organization
  • Ability to manage high-volume of work in fast-paced environment
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