Senior Manager, Global Compliance Operations

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profile Job Location:

Cambridge, MA - USA

profile Yearly Salary: $ 132000 - 165000
Posted on: 3 hours ago
Vacancies: 1 Vacancy

Job Summary

Why Sarepta Why Now

The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

  • Physical and Emotional Wellness

  • Financial Wellness

  • Support for Caregivers

For a full list of our comprehensive benefits see our website: Importance of the Role

Senior Manager Global Compliance Operations will report to the Senior Director Head of Global Compliance Operations and is a great opportunity for a highly motivated individual who is interested in independently managing critical components of the Compliance program in a dynamic and fast paced environment. This role requires strong attention to detail professionalism sound judgement and the ability to work cross functionally with multiple stakeholders.

The Opportunity to Make a Difference

This role is responsible for executing tasks and initiatives that span all three pillars of Sareptas Global Compliance Program. The successful candidate will contribute to activities supporting Global Healthcare Compliance Global Data Privacy and Data Management and Global Sanctions and Trade Controls as described below.

Training:

  • 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

Monitoring and Auditing plan:

  • 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

Risk Assessment:

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

Written Standards:

  • Assists in the annual review of all written standards as needed

Management of Compliance Tools:

  • 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

Other

  • Leads or participates in other key initiatives as requested.

More about You

  • Bachelors 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.

What Now

Were always looking for solution-oriented critical thinkers.

So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.

#LI-Hybrid

#LI-ES1

This position is hybrid you will be expected to work on site at one of Sareptas facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $132000 - $165000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas compensation philosophy and considers factors including but not limited to education training experience external market conditions criticality of role and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

Required Experience:

Senior Manager

Why Sarepta Why Now The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth thera...
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Key Skills

  • Employee Evaluation
  • Continuous Improvement
  • FDA Regulations
  • Management Experience
  • Process Improvement
  • Profit & Loss
  • Operations Management
  • Project Management
  • Strategic Planning
  • Leadership Experience
  • P&L Management
  • Supervising Experience

About Company

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We are focused on the development of precision genetic medicines to treat rare neuromuscular and central nervous system diseases. Learn more about Sarepta.

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