Senior Manager, Ethics and Compliance

Role Overview

• Partner in the development and/or revision, implementation, communication, and enforcement of the company’s compliance policies and procedures.
• Manage the company’s transparency reporting program, including federal and state aggregate spend reporting and disclosure laws.
• Keep apprised of changing and newly enacted legislature and requirements.
• Regularly reconcile and review company’s reportable transactions.
• Ensure accuracy of required reports/declarations and successful submission by the required deadlines.
• Appropriately educate and train key stakeholders on transparency requirements and process.
• Partner and liaise with global transparency colleagues on overall global transparency process and requirements.
• Serve as point of contact for transparency related questions.
• Manage key elements of the company’s compliance training program including:
• Administering training and education to ensure employees’ understanding and responsibilities regarding ethics, compliance, and legal matters.
• Overseeing content creation within the company’s Learning Management System and other software/technology platforms.
• Tracking, reporting, and ensuring timely completion of assigned trainings.
• Execute key elements of the company’s compliance auditing and monitoring program including:
• Performing auditing and monitoring to ensure business activities comply with established policies, procedures, and legal requirements.
• Partnering with the business to address detected noncompliance including corrective actions when needed.
• Tracking and reporting results of the auditing and monitoring activities and the corrective actions taken to Compliance leadership and other internal key stakeholders as needed.
• Interpreting findings/trends and carrying out corrective action and retraining as needed.
• Assist cross-functional teams by providing guidance, supporting decision-making, and ensuring operational activities align with regulatory requirements and the company’s ethical standards.
• Provide guidance and manage key compliance operations related to the HCP/HCO engagement process.
• Be an ambassador for communication around key compliance topics, resources, and special initiatives.
• Partner with Global compliance colleagues on key projects and share best practices.

Requirements

• 5+ years of experience with/in healthcare compliance within the pharmaceutical, biotech, or medical device industries
• Strong working knowledge of healthcare laws and regulations
• Working knowledge and previous experience in a compliance operations or project management position desired
• Excellent analytical skills with attention to detail and accuracy
• Ability to work in a fast-paced environment and demonstrate a sense of urgency
• A proven ability to build strong relationships with various stakeholders at all levels of the organization
• Ability to multi-task and prioritize demands
• Strong oral, written and communication skills
• Must be able to manage highly confidential information
• Highly proficient using Microsoft Word, Excel, and PowerPoint
• Ability to travel up to 10% required

Benefits

• Competitive compensation for your work
• Generous time off policy
• Summer Fridays
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments