bioMerieux is seeking a Compliance Senior Manager who will help lead and enhance the North American Compliance Program while working closely with the North American Compliance Officer. The bioMerieux Compliance Senior Manager will lead, assist, and facilitate compliance with North American and global laws, regulations, and company policies, including on matters, but not limited to, relating to interactions with health care professionals, fraud and abuse laws, conflicts of interest, state and federal transparency requirements, anti-corruption/anti-bribery, and third party risk management.
Essential Job Duties and Responsibilities
- A self-starter with a hands-on approach
- Excellent project management and problem solving skills
- Provide advice and problem-solving expertise on business projects/initiatives with compliance implications to ensure operations are conducted in full compliance with regulations and policies.
- Identify, escalate, and manage mitigation of compliance risks within scope, and recommend improvements to processes.
- Represent the Compliance Function to leaders within scope of responsibilities.
- Monitor the external environment, including regulations, and recommend improvements for compliance program.
- Provide regular training and coaching on ethics or trade compliance matters to leaders and employees.
- Advocate and develop a strong compliance culture within the business on a day-to-day basis.
- Enhance and lead, the development, enhancement, implementation, and administration of bioMerieux’s compliance program.
- Gather, review, and analyze information to identify compliance related trends, patterns, and risk indicators and independently advise on appropriate mitigation strategies, based on relevant regional requirements.
- Work effectively with other all key teams across the region (Legal, Finance, Sales, Marketing, Purchasing, etc.) to identify current and prospective ethics and compliance risks and help to enhance procedures to enable North America to effectively manage those risks.
- Provide support in monitoring and reviewing relevant new legal and regulatory developments.
- Regularly communicate compliance monitoring results to business process owners and senior appropriate management.
- Provide support for day-to-day compliance related questions and issues from across all lines of business.
- Assist company leaders to continue to embed a culture of compliance at bioMerieux including by training on and reinforcing employee and business partner awareness regarding the risks associated with illegal, unethical, or improper conduct.
- Review marketing, promotional, and scientific activities and materials for compliance with company policies and applicable laws and regulations.
- Participate in investigations of ethics and compliance related complaints and reports as requested.
- Partner closely with Global Ethics and Compliance colleagues on compliance initiatives.
- Manage the collection, validation, and reporting of data required by state and federal transparency regulations for North America
- Maintain a current working knowledge of U.S. and global laws, regulations, and industry guidance impacting the medical device industry including Office of Inspector General (OIG) guidelines, state and federal fraud and abuse laws, transparency reporting obligations, and privacy regulations, industry codes in relevant markets, marketing compliance laws, FCPA, anti-bribery laws, and others.
- Performs other duties as assigned.
Training and Education
- Bachelor’s degree is required.
- At least 8 years of relevant work experience in legal, audit, risk, or trade compliance, at least 4 years of working experience in compliance function, in the healthcare industry, and expertise in various compliance topics.
Minimum of four years of compliance experience in the pharmaceutical, healthcare, medical device, or clinical diagnostics industries is required.
Knowledge, Skills and Abilities
- Strong knowledge of U.S. and global laws, regulations, and industry guidance which governs healthcare compliance programs.
- Experience in advising on laws and regulations governing the medical device industry, including, but not limited to, FDA regulations, False Claims Act, Anti-kickback Statute, OIG Guidance, industry codes of practice (e.g., AdvaMed, Medec, Medtech, etc.), and other regulations/guidance around healthcare fraud and abuse concerns.
- Possess unquestionable reputation for ethics and integrity, personal values, and solid character.
- Maturity and decisiveness, including the ability to frame issues to support quick decision-making as well as an understanding of business in order to know how and when to escalate issues.
- Ability to logically analyze topics and address them pragmatically, working with stakeholders across all levels of the organization.
- Model resilience and flexibility by adapting well to new circumstances and adversity.
- Excellent written and verbal communication skills, including public speaking skills.
- Collaborative team player able to build positive relationships with colleagues and work as part of cross-functional teams.
- Provide ethics and compliance guidance to colleagues in a productive and supportive manner and maintain polite and professional demeanor in all interactions.
- Ability to effectively manage a substantial workload in a fast-paced environment.
- Genuine desire to work in a global business environment that involves broad cultural variety, with a high level of enthusiasm for diversity of work.
- Willingness to undertake some travel, including international travel, in support of responsibilities.
Occasional light lifting
Domestic travel will be required based on as-needed basis