A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
The Integrity and Ethics Operations Lead is responsible for executing against the EMD Serono Compliance Department’s annual Monitoring & Auditing (M&A) strategic plan. The lead will conduct monitoring activities and audits of various company records, manage the development and implementation of remediation & mitigation processes, assist with investigations related to findings and allegations of non-compliance with Company policy, prepare regular reports and presentations in a form that is consistent with internal and external reporting requirements.
- Monitor field Commercial, Medical Affairs and Managed Markets transactions, activities, and processes and perform transactional monitoring to assess compliance with Company policies and procedures.
- Manage and prioritize multiple complex projects; collaborating with multi-functional subject matter experts and stakeholders, as required.
- Prepare and provide reports, presentations, materials, guidelines, and documents for employees, senior management.
- Develop and demonstrate knowledge and competency to serve as a compliance and ethics subject matter expert.
- Support the Chief Compliance Officer and other leaders in Compliance with E&C Monitoring & Auditing in facilitating and raising awareness of the Ethics & Compliance program while fostering accountability for compliance throughout the organization.
- Maintain understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance and proposes updates to ethics & compliance program, as appropriate.
- Identify, analyze, and mitigate potential business and ethics risks to the organization.
- Support the development and manage the implementation of a robust ethics and compliance monitoring and auditing plan.
- Develop and maintain knowledge and understanding of EMD Serono’s disease states and products and industry regulations and guidelines - laws and regulations regarding pharmaceutical advertising and promotion, Federal Anti-Kickback Statute, False Claims Act, as well as EMD Serono policies and procedures, and government reporting requirements as needed.
- Develop and manage protocols, guidelines and associated internal communication and documentation related to E&C testing and monitoring.
- Develop and manage the remediation and mitigation process on for the M&A team
- Review records and systems relating to interactions with healthcare professionals and institutions, conduct field monitoring visits and monitor various company-sponsored activities to ensure adherence with relevant laws, regulations, industry codes, and company policies.
- Support E&C audits for North America with the potential to gain exposure to global activities in support of annual auditing plan and/or ad hoc audits as requested.
- Review and follow-up on suspected areas of non-compliance and collaborate with EMD Serono Ethics & Compliance teams as needed.
- Prepare reports and presentations summarizing monitoring and auditing findings and remediation for management and external government agencies as requested.
Who you are:
- Extensive working knowledge of US and international fraud and abuse laws and regulations – such as the False Claims Act, the Anti-Kickback Statute, the Foreign Corrupt Practices Act, and the UK Bribery Act – and should have experience working with or for biotechnology/pharmaceutical companies on these issues.
- Ability to work collaboratively and strategically with colleagues in legal and the business to drive a culture of ethics and integrity across the global organization.
- Bachelor's degree required
- A minimum of 5 years combined pharmaceutical, legal, regulatory, and compliance experience required.
- Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food & Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting requirements.
- Compliance monitoring and auditing experience in the Pharmaceutical or life sciences industry is strongly preferred.
- Experience working under a government agreement (e.g. Corporate Integrity Agreement, Consent Decree, etc.) is required
- Demonstrates strong interpersonal skills and ability to influence at all levels of the organization.
- Ability to manage multiple projects concurrently and collaborate across several functional areas, meeting internal and external deliverables with high degree of accuracy.
- Highest level of ethics and personal integrity
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.