Senior Manager, Healthcare Compliance International
Immunocore

Rockville, Maryland

Posted in IT


Job Info


About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners. Key ResponsibilitiesMain purpose of the role:

The purpose of the Senior Manager, Healthcare Compliane role is to establish, implement, lead, and manage the Company's global Anti-Bribery Anti-Corruption (ABAC) Program, as part of the Global Healthcare Compliance Program.

The Senior Manager, Healthcare Compliance will drive compliance activities, have compliance oversight, and be the key Compliance Department lead for Immunocore business activities and responsibilities relating to countries where Immunocore is or will be commercializing medicinal products through distribution partnerships and/ or other vendor arrangements outside of United States, UK, and certain European countries (this territory referred to as "Rest of World")

The holder of the position:

Reports directly to the Chief Compliance Officer.
Has the authority to investigate and challenge all aspects of business activities in Rest of World and/ or relating to the ABAC Program
Works closely with management at all levels to ensure that high standards are maintained with respect to Immunocore's standards, policies and procedures.
Relays all relevant feedback on compliance matters to the Chief Compliance Officer, or in their absence, the General Counsel. This includes opportunities for improvement in efficiencies and quality, as well as a reduction in the company's vulnerability to non-compliance.
Ensures appropriate confidentiality is maintained at all times regarding information relating to individuals and matters of company business.

Key Responsibilities:

Company's subject matter expert and key advisor for ABAC
Compliance representative for transactions with Compliance components (including ABAC), performing and/ or overseeing Compliance due diligence and recommendations
Engage and oversee outside counsel, auditors, and other service providers necessary to support the ABAC Program and Rest of World Compliance Program
Support counter-party compliance needs, assessments, monitoring by Procurement and Business Development
Serving as a resource and point-of-contact for questions from internal stakeholders and TPs going through the ABAC process
Processing requests for ABAC Due Diligence on new and existing third parties, including communicating with internal business relationship owner and TPs to gather all required information to complete the ABAC Due Diligence process
Conducting first-level review of ABAC Due Diligence questionnaires and following up on areas that require further inquiry with internal business relationship owner and if relevant the TP directly.
Preparation of regular ABAC Due Diligence metrics and dashboards using these analytics
Analysing issues, audit, and monitoring results to drive continuous improvement by recommending adjustments to our risk-based ABAC Due Diligence program
Leading the development, maintenance, and evolution of the Global ABAC Due Diligence policy, process, resource tools and controls, to ensure compliance with applicable laws, regulations and industry codes and alignment with relevant global policies and procedures
Development and implementation of Global ABAC Due Diligence training
Attendance at scheduled distributor business meetings as part of distributor monitoring
Other responsibilities as may be assigned from time to time in the company's discretion
Serve as Immunocore's subject matter expert and key advisor for ABAC
Develop with Immunocore's third-party life-cycle management program in partnership with corporate leadership
Serves on Corporate Compliance Committee

PERSON SPECIFICATION

10 or more years of experience in healthcare compliance, including at least 5 years of experience in a similar healthcare compliance, quality, or legal role.

Knowledge & Application

Applies broad expertise and knowledge in Healthcare Compliance. Leads and contributes to development of company's concepts, principles, and objectives to achieve goals in creative and effective ways. Has a clear understanding of departmental direction and is expected to have opinions on strategic direction. Demonstrates subject matter expertise gained through significant professional development. Serves as a best practice resource for Healthcare Compliance.

Collaboration & Interaction

Proactively interacts with key stakeholders across the business regarding highly complex Healthcare Compliance issues. Requires ability to influence, negotiate, and persuade on difficult concepts. Regularly presents at and leads high-profile internal and external meetings.

Strategy & Impact

Contributes to the development of strategy of Healthcare Compliance in the region and drives and executes plans. Heightened strategic awareness of the market, competitive landscape and opportunities.

Complexity & Problem Solving

Works on routine problems of limited scope. Helps to identify where an issue has occurred. Gathers and interprets information specific to an issue from a variety of sources. Resolves straightforward issues accurately. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Applies learned techniques and contributes to analysis and investigation to help solve problems. Exercises judgment within defined procedures and practices to determine appropriate action.

Essential Competencies:

Excellent written and verbal communications skills in English
Must work with professional discretion and confidentiality
High Prioritization
Self-motivated- able to work autonomously and independently
Strong attention to detail
Strong organizational skills
Able to anticipate challenges and devise strategies for success
Result and deadline orientated
Ability to manage multiple priorities and adjust workload as business needs require
Demonstrated ability to meet deadlines
Collaboration Skills, and ability to work as part of a diverse, cross-functional team
Excellent presentation skills
Personal Effectiveness/Credibility
Flexibility

Education & Qualifications:

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
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)



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