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- Senior Manager, Compliance
Description
At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.
Reporting to the Chief Compliance Officer, the Sr. Manager, Compliance will have primary responsibility for executing key elements of Viridian’s auditing, monitoring, and risk management programs. This comprehensive role entails partnering with various stakeholders across the organization to identify potential issues, mitigate risks, uphold ethical standards, and foster a culture committed to compliance.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
- Conduct regular audits of Medical, Commercial, and operational activities to verify compliance with applicable laws, regulations, and company policies
- Monitor high-risk activities such as Healthcare Professional (HCP) engagements, speaker programs, advisory boards, and patient services interactions to identify potential issues and non-compliance
- Track and report outcomes of auditing and monitoring activities to senior leadership and the Compliance Committee
- Perform periodic risk assessments to identify vulnerabilities and recommended mitigation strategies
- Collaborate cross-functionally to address issues and risks identified to implement corrective actions as appropriate
- Participate in the review and approval of HCP engagements and support the business in accessing and training on key compliance tools and areas
- Responsible for the intake of all questions to the Compliance mailbox and generation of subsequent compliance metrics for senior leadership and the Compliance Committee
- Assist in the development and maintenance of relevant policies, procedures, work instructions, and training plans related to key areas within Compliance
- Assist with the data collection and generation of US and global transparency reports
Requirements
- Requires a B.A./B.S. degree or equivalent (Advanced degree preferred) with 4+ years in compliance, audit and/or other related experience
Pharmaceutical experience required - Certified in Healthcare Compliance (CHC) and/or Project Management Professional (PMP) a plus.
- Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including global aggregate spend and other reporting/sunshine laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, government settlements (DPAs and CIAs), and state marketing and price reporting compliance laws
- Experience with US transparency reporting required. Global transparency reporting experience a plus
- Experience developing and executing audits and monitoring
- Requires the ability to be flexible and adaptable to changes. This individual must feel comfortable in creating new processes and grow with the organizational and regulatory changes
- Excellent organization, communication, and project management skills with an ability to work in a collaborative, cross-functional environment
- Candidate must be able to work independently and prioritize multiple demands
- Proven mindset of proactive continuous improvement
- Efficient independent worker with ability to focus and drive for results
- Strong attention to detail
- Ability to work in a fast-paced environment and to handle multiple tasks
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to 40-50%
- The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
- Competitive pay and stock options for all employees
- Competitive medical, dental, and vision insurance
- 100% Paid Parental Leave
- Short- and long-term disability coverage
- Life, Travel and AD&D
- 401(k) Company Match with immediate company vest
- Employee Stock Purchase plan
- Generous vacation plan and paid company holiday shutdowns
- Various fertility, mental, financial, and proactive physical health programs
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian 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.
Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.