Senior Manager, Ethics and Compliance
About The Position
This role partners in the development, implementation, communication, and enforcement of the company’s compliance policies and procedures. It also manages the company’s transparency reporting program, including federal and state aggregate spend reporting and disclosure laws. The position requires staying apprised of changing legislation, reconciling and reviewing reportable transactions, ensuring accuracy of required reports/declarations, and successful submission by deadlines. Additionally, it involves educating key stakeholders on transparency requirements, partnering with global transparency colleagues, and serving as a point of contact for transparency-related questions. The role also manages key elements of the company’s compliance training program, including administering training, overseeing content creation, and tracking completion. Furthermore, it executes key elements of the compliance auditing and monitoring program, partners with the business to address noncompliance, and provides guidance to cross-functional teams to ensure alignment with regulatory requirements and ethical standards. The Senior Manager will also provide guidance and manage key compliance operations related to the HCP/HCO engagement process and act as an ambassador for communication on key compliance topics.
Requirements
- 5+ years of experience with/in healthcare compliance within the pharmaceutical, biotech, or medical device industries, with strong working knowledge of healthcare laws and regulations.
- 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.
Nice To Haves
- Working knowledge and previous experience in a compliance operations or project management position desired.
Responsibilities
- 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.
- Administer training and education to ensure employees’ understanding and responsibilities regarding ethics, compliance, and legal matters.
- Oversee content creation within the company’s Learning Management System and other software/technology platforms.
- Track, report, and ensure timely completion of assigned trainings.
- Execute key elements of the company’s compliance auditing and monitoring program.
- Perform auditing and monitoring to ensure business activities comply with established policies, procedures, and legal requirements.
- Partner with the business to address detected noncompliance including corrective actions when needed.
- Track and report results of the auditing and monitoring activities and the corrective actions taken to Compliance leadership and other internal key stakeholders as needed.
- Interpret findings/trends and carry 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.
Benefits
- Competitive compensation
- 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
- Competitive 401(k) match
- Tuition and wellness reimbursements
- Comprehensive medical, dental, and vision package
- Additional recognition awards
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
