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Sarepta Therapeutics · 2 weeks ago

Senior Manager, Global Compliance Operations

Cambridge, MA

Full-time

Hybrid

Senior Level

$132K/yr - $165K/yr

7+ years exp

Sarepta Therapeutics is a leader in genetic medicine, focusing on Duchenne muscular dystrophy and other diseases. The Senior Manager, Global Compliance Operations will manage critical components of the Compliance program, ensuring adherence to healthcare compliance, data privacy, and trade controls.

BiotechnologyGeneticsHealth CareTherapeutics

Growth Opportunities

No H1B

Responsibilities

Work with manager to develop the annual training plan based on risk assessment

Support, prepare, and conduct Compliance trainings as needed based on business activity or part of monitoring remediation

Works with HR to distribute annual eLearning modules and track to completion

Works with HR to distribute annual policies and track to completion

Works with Corporate Communications to distribute annual Compliance Minutes Video series

Responds to internal audit request for training statistics

Work with manager on the development of the annual monitoring plan based on the risk assessment

Live and desktop monitoring

Live co-travels with field team

Reviews and analyzes monitoring and auditing results twice a year to test the effectiveness of the Compliance program

Leverages transparency data to test key internal controls and inform the risk-based monitoring plan

Supports manager in the annual review of company risks based on activities

Assists in the annual review of all written standards as needed

Tiering & FMV tool including adding more countries and specialties as requested by the business

Needs Assessment Forms

Maintenance of Workday Learning resources lifecycle

Nucleus page

Maintains all user guides associated with tools

Leads or participates in other key initiatives as requested

Qualification

Compliance program managementRisk assessmentProject managementPharmaceutical industry experienceData privacy managementMonitoringAuditingMicrosoft Office SuiteInterpersonal skillsVerbal communicationWritten communicationTeam collaborationAttention to detail

Required

Bachelor's degree required

Minimum of 7 plus years of relevant experience in the pharmaceutical, biotech, or medical devices industry with four years of direct compliance responsibilities

Strong planning and project management skills

Strong computer software skills (Microsoft Office Suite – Word, Excel, PowerPoint, and Visio); ability to manage databases and generate meaningful tables and charts for executive presentations

Team player with a high level of interpersonal skills and collaborative working style to effectively work cross-functionally within the company

Strong verbal and written communication skills, including ability to communicate with a wide range of individuals and constituencies in a diverse community

Ability to prioritize multiple tasks and meet deadlines