Job description

Healthcare Compliance Specialist

Conshohocken, Pennsylvania, United States

HEALTHCARE COMPLIANCE SPECIALIST 

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

The Role:

Immunocore’s Global Healthcare Compliance Program is seeking a Contractor for Healthcare Compliance, to help build and support the Program.

This is a temporary position, anticipated to be for 6 months.

Responsibilities:

Support efforts related to our Global Effective Healthcare Compliance Program (“Program”), including:

  • Supporting Chief Compliance Officer in building and managing the Program
    • Serving as Secretary to Healthcare Compliance governance committees, ensuring necessary committee reviews, setting agendas, and handling minutes (drafting, circulating, and archiving).
    • Advising company leaders and personnel regarding requirements of industry codes, including PhRMA, ABPI, and EFPIA.
    • Delivering trainings and materials related to multiple audiences.
    • Managing and overseeing monitoring of company and vendor activities for consistency with the Program.
  • Primary responsible person on global Compliance team for global Compliance team efforts on Policy / SOP / tool / training development, including:
    • Identifying need for policies/ SOPs/ tools (such as job aids).
    • Leading Compliance efforts to develop and/ or support development of policies/ SOPs/ tools.
    • Managing process for review and approvals for policies/ SOPs/ tools.
    • Serving on related Quality Committees.
    • Developing e-training and training curriculum, and liaising with other training resources.
    • Identifying target audience for materials and training.
    • Managing logistics for training, including liaising with other resources for support of training.
    • Coordinating onsite/ external training (such as at Medical Congresses, sales organizations, etc.).
    • Coordinating and providing content for quarterly Compliance newsletter for the Company and any other updates related to ongoing training and awareness for employees.
  • Serve as subject matter expert and provide key input regarding European healthcare compliance requirements, including:
    • Performing EU/ UK and EFPIA/ ABPI compliance reviews and supporting certifications and attestations by Company (including CEO, CCO, and other leaders).
    • Conducting compliance review for promotional and product material/ event review committee(s).
    • Coordinating with external vendors and resources.

Qualifications: 

  • 5 or more years of experience in healthcare compliance, including at least 3 years of experience in a similar healthcare compliance, quality, or legal role.
  • Bachelor's degree
  • Proficiency in MS Office (Excel, PPT, XLS, Word, and Project) is critical
  • Advanced data analytical skills using Microsoft Excel tools
  • Comfortable and interested in working with systems and technology to support job responsibilities
  • Demonstrated project management knowledge and success in driving projects across teams and individuals with varied reporting structures

Preferred Qualifications:

  • Familiarity Global Healthcare Compliance Programs for Pharmaceutical Companies.
  • Familiarity with relevant industry codes (PhRMA, ABPI, EFPIA).
  • Familiarity with Veeva systems.
  • Healthcare compliance coursework/ certification(s).
  • Proximity/ ability to work in person at Immunocore’s UK or Ireland office (flexible working arrangements can be considered).
  • Overnight travel is expected.

 

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.

Immunocore is an E-Verify employer. 

 

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