Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

Role & Function

At Sobi, we are transforming the lives of people affected by rare diseases. As a specialized international biopharmaceutical company, we provide sustainable access to innovative therapies in the areas of hematology, immunology and specialty care. We bring something rare to rare diseases – a belief in the strength of focus, the power of agility and the potential of the people we are dedicated to serving.

Sobi is currently recruiting a team-oriented, self-motivated and enthusiastic Compliance professional with relevant industry experience to manage and support multiple aspects of Sobi North America’s Compliance Program This position is based in Durham, NC or Waltham, MA and reports to the Senior Director of Compliance, North America.

The Senior Manager, Healthcare Compliance North America will provide a broad range of compliance support throughout Sobi’s North American organization; partnering with the business to sustain Sobi’s ethical and compliant culture and develop practical ways to uphold the legal, regulatory, and ethical obligations of a pharmaceutical company. S/he will also partner with Sobi’s global colleagues across the entire Sobi organization on compliance matters as they relate to North America.

** Please note, this is a remote position with approximately 20% travel. North American Headquarters are based out of Durham NC and Waltham MA. Durham area preferable but will consider Waltham for the right candidate.

Key Responsibilities

• Partner in the development and/or revision, implementation, communication, and enforcement of the company’s compliance policies and procedures
  • Manage key elements of the company’s compliance training program including:
  • Partnering with the business to address non compliance including corrective actions when needed
  • Administering training and education to ensure employees and key external partners’ understanding and responsibilities regarding ethics, compliance, and legal matters
  • Overseeing content creation within the company’s Learning Management System and other software/technology platforms
  • Tracking, reporting, and ensuring timely completion of assigned trainings
  • Carrying out any related logistical, planning, and operational support
• Execute key elements of the company’s compliance auditing and monitoring program; including:
  • Performing auditing and monitoring to ensure business activities comply with established policies, procedures, and legal requirements
  • Tracking and reporting results of the auditing and monitoring activities and the corrective actions taken to Compliance leadership and other internal key stakeholders as needed
  • Interpreting findings/trends and carrying out corrective action and retraining as needed
• Support the management of the company’s transparency reporting program, including federal and state aggregate spend reporting and disclosure laws
  • Keep apprised of changing and newly enacted legislature and requirements
  • Regularly reconcile and review company’s reportable transactions
  • Ensure accuracy of required reports/declarations and successful submission by the required deadlines
  • Appropriately educate and train key stakeholders on transparency requirements and process
  • Partner and liaise with global transparency colleagues on overall global transparency process and requirements
  • Serve as point of contact for transparency related questions
• Provide guidance and manage key compliance operations related to the HCP/HCO engagement process
• Be an ambassador for communication around key compliance topics, resources, and special initiatives
• Partner with Global compliance colleagues on key projects and share best practices

Qualifications

• Bachelor’s degree required
• Minimum of 8 years of experience with/in healthcare compliance within the pharmaceutical, biotech, or medical device industries, with strong working knowledge of healthcare laws and regulations
• Working knowledge and previous experience in a compliance operations or project management position desired
• Excellent analytical skills with attention to detail and accuracy
• Ability to work in a fast-paced environment and demonstrate a sense of urgency
• A proven ability to build strong relationships with various stakeholders at all levels of the organization
• Ability to multi-task and prioritize demands
• Strong oral, written and communication skills
• Must be able to be manage highly confidential information
• Highly proficient using Microsoft Word, Excel, and PowerPoint
• Data analytics in Tableau (preferred)

If you are interested in being considered for this role, then please attach an updated copy of your resume (as a MS-Word or PDF file) while submitting your application.

Why Join Us?

We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.

This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain.

Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

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