- Assist in developing auditing and monitoring plans
- Conduct in-person monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations, and company policies
- Conduct desk monitoring of Medical, Clinical, Commercial, and other departmental activities to ensure compliance with applicable laws, regulations, and company policies
- Review of Medical, Commercial, and other internal documentation to ensure compliance with company SOPs and policies
- Track and report progress of Compliance auditing and monitoring, including preparation of reports/presentations/metrics to communicate findings throughout multiple levels of the organization
- Maintain knowledge of industry and enforcement trends and regulations to continuously inform and improve auditing and monitoring tools and templates
- Maintain relevant auditing/monitoring systems, tools, and dashboards
- Work alongside employees and company leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving
- Requires the ability to be flexible and adaptable to changes. This individual must feel comfortable in creating new processes and grow with organizational and regulatory changes
- Optimize compliance data analytics and assist in the development of data analysis tools and systems to maximize departmental efficiency
- Maintain awareness of applicable laws and regulations and keep current with changes that may affect Kiniksa's Compliance program
- 3-5+ years in compliance, audit, monitoring and/or other related experience in Biotech/Pharmaceuticals
- B.A./B.S. degree or equivalent required (advanced degree preferred)
- Certified Fraud Examiner (CFE), Certified Internal Auditor (CIA), Certified in Healthcare Compliance (CHC), or Project Management Professional (PMP) a plus
- Experience developing and 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
- Experience with risk assessments and business continuity planning preferred
- Experience managing complex projects with a strong attention to detail
- Strong operational and project management skills required
- Excellent organization and presentation skills. Candidate must have strong team orientation, decision making, and problem-solving skills
- Demonstrated strong written and verbal communication skills
- Proven mindset of proactive continuous improvement
- Efficient independent worker with ability to focus and drive for results
- Ability to work in a fast paced-environment and to handle multiple tasks
- Strong commitment to compliance and ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.), as well as previous significant experience using report building software such as Tableau, Smartsheet, Cognos Report, Query Studio, or a similar software package
- Ability to travel up to 50%
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Manager, Compliance - Lexington, United States - Kiniksa Pharmaceutical
Description
Reporting to the Associate Director, Compliance, the Manager, Compliance will serve an important role in Kiniksa's continued enhancement of its Compliance program.
This position will work to assist in the implementation, maintenance, and continued improvement of Kiniksa's compliant and ethical practices and behaviors through close collaboration with internal and external business partners.
The Manager, Compliance will also be primarily responsible for executing key elements of Kiniksa's auditing and monitoring program.This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
Auditing & Monitoring
Qualifications:
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.
