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Disc Medicine · 19 hours ago

Senior Manager, Compliance

Massachusetts - Hybrid

Full-time

Hybrid

Senior Level

$135K/yr - $183K/yr

7+ years exp

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients with hematologic diseases. They are seeking a Senior Manager, Compliance to enhance their Compliance Program and support their first product launch, driving execution and continuous improvement in compliance efforts.

BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics

Responsibilities

Support the development, implementation, and continuous improvement of Disc’s Compliance Program to support a strong ethical culture across the organization

Oversee the management, adoption, and use of compliance tools, dashboards, reports, workflows, and analytics to monitor program effectiveness

Design and deliver role-specific training and communications to support awareness and accountability

Provide guidance and operational oversight of compliance with laws and industry standards (e.g., PhRMA Code, Sunshine Act, state/local transparency laws)

Support Disc’s compliance risk assessment process, and the development and implementation of the auditing and monitoring plan

Identify and track trends across auditing and monitoring activities and promote continuous improvement opportunities

Conduct monitoring activities including field rides, Speaker Programs, congresses, and other promotional and scientific events

Participate in the Annual Plan and Needs Assessment Form process for HCP, Patient, and Payor engagements, including process development, training, fair market value analyses, debarment/sanctions screening, and supporting the contracting process as needed

Stay informed of evolving healthcare laws, regulations, and enforcement trends and apply insights to enhance Disc’s Compliance Program and to educate business partners with tailored communications

Contribute to enterprise-wide projects, workstreams, and systems (e.g., LMS, Veeva, Concur) to provide Compliance input as needed

Build relationships and trust across business functions to support a culture of compliance into strategic and operational decision making

Qualification

Healthcare Compliance CertificationBiopharmaceutical Industry ExperienceCompliance Program DevelopmentRegulatory Requirements KnowledgeProject ManagementCollaborationOrganizational SkillsFlexibility

Required

Bachelor's degree required; master's or other advanced degree or certification (e.g., Healthcare Compliance Certification, CPA, CFE, etc.) a plus

7-10 years of experience focused within the biopharmaceutical industry, either in-house or as a consultant

Strong knowledge of healthcare compliance frameworks (e.g., OIG 7 Elements), regulatory requirements (e.g., Sunshine Act and state/local transparency laws), and industry codes (e.g., PhRMA Code)

Strong project management and organizational capabilities specifically related to compliance tools, systems, and workflows

Experience creating and enhancing compliance programs including components of policy/SOP maintenance, risk assessments, auditing and monitoring, and training

Flexibility to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude. Comfortable managing multiple priorities

Ability to travel up to 10-25% of the time for business meetings and field monitoring