Ethics & Compliance Manager - Bedford, United States - Lantheus Medical Imaging Inc

Description

Job Description

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of Role:

The Ethics & Compliance Manager Position reports directly to the Ethics and Compliance Director, who reports to the VP of Enterprise Risk Management & Compliance (including Data Privacy and Protection). This individual will support the development, implementation, and maintenance of the Operational elements of the Compliance Program, which would include assistance with developing SOPs, drafting training program content, executing monitoring and auditing plans and case management related to compliance inquires. Responsibilities also include supporting the Company's compliance with applicable privacy requirements. The role will be part of an effective team of compliance professionals and interact with personnel at various levels of the Company.

The successful candidate should have experience being part of a team supporting the operational aspects of Compliance & Privacy program and has a passion for making ethics and compliance a core component of interactions with all our stakeholders. This individual understands the importance of embedding and championing compliance and ethics throughout the organization. Furthermore, the successful candidate will also have good communication skills and act as a change agent to engender a culture of compliance within the organization.

ESSENTIAL RESPONSIBILITIES:

• Support development of a proactive and coordinated approach to compliance monitoring and operations to proactively identify, mitigate, and monitor risk including, but not limited to, activities such as:
• Support the monitoring program build, e.g., the development of guides, processes, and communications that will be used;
• Partner with internal stakeholders who own systems and databases that contain information critical to audit & monitoring activities;
• Obtain access and learn how to use those tools to execute audit & monitoring activities;
• Evolve audit & monitoring activities as the company engages in new business activities;
• Conduct virtual and in-person live monitoring;
• Conduct compliance audits (desktop and off-site);
• Track and report progress of Compliance auditing and monitoring, including preparation of reports/presentations/metrics to communicate observations;
• Support business accountability for remediating audit & monitoring observations;
• Analyze audit & monitoring data to proactively identify trends; and
• Maintain knowledge of industry and enforcement trends and regulations to continuously inform and improve auditing and monitoring tools and templates.
• Optimize compliance data analytics and assist in the development of data analysis tools and systems to maximize departmental efficiency.
• Assist with case management related to compliance inquires.
• Maintain awareness of existing and evolving compliance, ethics, privacy and related legislation, regulations, frameworks, and other marketplace/industry dynamics relevant to Lantheus and its industry, business, and operations to determine the practical effects on and requirements for Lantheus programs, policies, communications, and training needs.
• Assist with drafting and maintaining compliance operating procedures and training material content.
• Assist the team in driving the cross-functional strategic and operational execution of company-wide data privacy and protection initiatives to ensure Company is meeting its regulatory priorities, and protecting critical data, which includes:
• Support the team to operationalize the Company's privacy strategy and management framework.
• Support the deployment of tools (automation) to enhance data privacy controls.
• Develop and deliver privacy education and awareness materials to internal stakeholders.
• Act as a change agent encouraging an environment that employs accountability, collaboration and trust while fostering teamwork and execution.
• Actively demonstrate the Lantheus values of helping people be their best; respecting one another and acting as one; owning the solution and making it happen; learning, adapting, and winning; knowing someone's health is in our hands.
• Ability to be flexible and adaptable to changes. Must feel comfortable in creating new processes and grow with organizational and regulatory changes.

PROFESSIONAL EXPERIENCE / QUALIFICATIONS:

• Minimum years in compliance, audit, monitoring and/or other related experience, and at least 3 years' experience preferred in Biotech/Pharmaceuticals.
• Basic understanding of key elements required for a Privacy program.
• BA./B.S. degree or equivalent in a related field required (advanced degree preferred).
• Certified Fraud Examiner (CFE), Certified Internal Auditor (CIA), Certified in Healthcare Compliance (CHC), or Project Management Professional (PMP), CIPP certification (e.g. CIPP/US, CIPM, CIPP/C, CIPT, CIPP/E), not required, a plus.
• Experience in document management and process flow creation.
• Experience executing audits and monitoring activities.
• Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing compliance laws.

CAPABILITIES / COMPETENCIES:

Lantheus is also looking for the right fit for its Management team and the Company, which means the successful candidate must also have:

• A passion for performing meaningful work that impacts patients' lives;
• The highest integrity and sound judgment;
• Interpersonal skills and a collaborative style;
• An ability to escalate issues appropriately;
• Confidence navigating a highly regulated, public company environment;
• Strong reasoning skills and a creative, pragmatic, solution-oriented and cross-functional problem-solving approach;
• Strong oral and written communication and presentation skills;
• An innate and unshakable sense of ownership;
• An astute resourcefulness with which to attack unfamiliar legal and regulatory frameworks and business problems efficiently and effectively;
• A proactive, entrepreneurial mindset and a willingness to "roll up your sleeves" to get the job done;
• A serious interest in developing and implementing cross-functional process improvement initiatives;
• A passion, curiosity, receptiveness and capacity to learn about the Company, its complex and evolving businesses and industry, the underlying clinical use of its products, and the sale, delivery and use of its products within the healthcare system; and
• An ability to set and manage multiple, constantly-changing, sometimes conflicting priorities in a dynamic, fast-paced environment.

OTHER REQUIREMENTS:

Periodic travel to other Company sites and events will be required.

CORE VALUES:

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen

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