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

Mark Lane

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Mark Lane

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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.


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 inperson live monitoring;
  • Conduct compliance audits (desktop and offsite);
  • 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 crossfunctional strategic and operational execution of companywide 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. deg

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