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The Senior Project Manager, Compliance Operations, will play a critical role in managing and enhancing Dompé’s healthcare compliance program through program administration, operations execution, and communications and training support—all in the service of Dompé’s mission to deliver first-in-class disease-modifying therapies to change patients’ lives. The ideal candidate will also be a self-motivated and agile team player, supporting additional strategic priorities as they arise.
Job Responsibility:
Embody Dompé’s commitment to ethics and integrity and values-based decision-making, and foster this mindset in clients, partners, and team members
Support U.S. Compliance team with operational services for the business
Oversee, monitor, and support the U.S. Compliance team mailbox, and maintain “Frequently Asked Questions” documents to support tailored compliance communications
Provide overall operations project management support for U.S. Compliance team
Maintain all compliance files in an organized manner and serve as custodian of such files
Serve as secretary at U.S. Compliance team meetings
Maintain master tracker of ongoing workflows and follow-up with appropriate individuals as needed
Track U.S. Compliance department monthly spend and reconcile monthly spend with budget
Work with U.S. Compliance team, Procurement, and Legal, to select, qualify, onboard, and manage U.S. Compliance vendors and consultants
Provide tactical support for healthcare professional (“HCP”) engagements, including through conducting screenings and annual exclusion and debarment checks
Work with cross-functional partners and external vendors to manage the collection, validation, and submission of required information and data for transparency reporting
Assist U.S. Compliance team in conducting internal compliance investigations, including through maintaining notes, requesting and reviewing files, and providing initial drafts of reports
Support compliance awareness campaigns, including managing Compliance team presence at Company meetings
Create PowerPoint slides, reports, and other messaging for the Ethics & Compliance Committee and other stakeholders
Assist in the maintenance of Compliance content on both the public website as well as the Intranet page
Maintain and compile training records and documentation across different types of training, including in-person, via LMS, and virtually on MS Teams
Requirements:
Bachelor’s or Master’s degree
5+ years of experience in compliance, audit, or legal, of which 2-3 years in the healthcare, biotech, or pharmaceutical industry
Extensive experience with laws, regulations, and industry guidance that affect the biotech, pharmaceutical, and rare disease space, including but not limited to OIG, PhRMA Code, healthcare standard operating procedures, ABAC laws, and transparency reporting
Strong attention to detail and strong organizational skills
Self-starter who can lead projects independently from inception to completion with minimal supervision
Proven success in building cross-functional partnerships and delivering results
Ability to operate in a fast-paced, dynamic environment with multiple priorities
Clear, concise, and persuasive verbal and written communication, including presentation skills
Proficient in Microsoft Office applications, SharePoint, and LMS