Senior Project Manager, Compliance Operations

Senior Project Manager, Compliance Operations

Job Area:
Legal/Compliance

Job Category:
Professionals

Job Site:
Remote

Location:

San Mateo, CA, US

Dompé is an Italian bio‑pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand‑in‑hand with a commitment to research and development to meet unsatisfied therapeutic needs.

Established in 1940 in Milan, Dompé has an industrial and biotech research hub in L’Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The company has approximately 900 employees. The US headquarters of Dompé are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations).

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.

• 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

• 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

• Comprehensive…