What are the responsibilities and job description for the Senior Manager, Healthcare Compliance position at Immunocore?
Location of role Conshohocken PA, Gaithersburg, MD
Department Legal
Key Responsibilities Main Purpose of Job:
The primary purpose of this role is to leverage emerging expertise and subject matter knowledge in the field of healthcare compliance to address significant and unique complex issues, aligning work with the wider Immunocore’s strategy. The individual will operate with the highest standards of integrity to help build a best-in-class compliance program.
As Senior Manager, Compliance Operations, you be a key part of Immunocore’s compliance team and will serve as an in important business partner to other internal and external stakeholders to ensure that they can achieve strategic business objectives while adhering to all relevant legal, regulatory, and compliance guidelines to ensure global compliance at Immunocore.
The incumbent will be expected to understand how their role connects with the wider company strategy and contribute to functionally strategic decisions. Interactions with lower and senior management will be frequent, requiring the ability to persuade others in sensitive situations while preserving relationships
Key Responsibilities:
Essential Qualifications:
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
his is a generic vacancy template
About the Company Immunocore (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.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
Department Legal
Key Responsibilities Main Purpose of Job:
The primary purpose of this role is to leverage emerging expertise and subject matter knowledge in the field of healthcare compliance to address significant and unique complex issues, aligning work with the wider Immunocore’s strategy. The individual will operate with the highest standards of integrity to help build a best-in-class compliance program.
As Senior Manager, Compliance Operations, you be a key part of Immunocore’s compliance team and will serve as an in important business partner to other internal and external stakeholders to ensure that they can achieve strategic business objectives while adhering to all relevant legal, regulatory, and compliance guidelines to ensure global compliance at Immunocore.
The incumbent will be expected to understand how their role connects with the wider company strategy and contribute to functionally strategic decisions. Interactions with lower and senior management will be frequent, requiring the ability to persuade others in sensitive situations while preserving relationships
Key Responsibilities:
- Develop and maintain trusted partnerships and effective lines of communication across multiple business units, including commercial and medical organizations.
- Serve as a dedicated business partner to the field, including senior leadership.
- Identify potential areas of compliance risk and develop plans to mitigate these risks.
- Stay abreast of regulatory changes, emerging trends, and industry best practices.
- Lead the collection, validation, and submission of transparency reports in accordance with US and International requirements.
- Support comprehensive audits of internal processes and practices and live monitoring of business activities to ensure compliance with relevant US healthcare laws and regulations.
- Monitor applicable and evolving regulatory requirements (e.g., OIG guidance, FCPA, GDPR, and state-specific laws) and assess their impact on business operations.
- Create and maintain compliance policies and procedures.
- Develop, implement, and manage compliance training programs for employees at all levels.
- Conduct regular training sessions and provide guidance on compliance-related topics.
- Monitor and track employee participation in training programs and ensure ongoing compliance education.
- Investigate, document and propose solutions for compliance issues and concerns, executing recommendations as appropriate.
- Assist investigations into potential compliance violations, implement corrective action plans, and ensure proper documentation and reporting.
- Prepare and present compliance updates for Corporate Compliance Committee / senior leadership.
- Lead Ad Hoc compliance projects
- N/A
Essential Qualifications:
- Typically requires a Bachelor's degree and 8 years of related experience; or equivalent experience.
- At least 3 years in the health care compliance/privacy sector
- Certification in healthcare compliance (e.g., CHC, CCEP) desired
- Ability to develop trusted partnerships, provide feedback clearly and succinctly maintain and effective lines of communication across the functional units in and out of the company, including the commercial and medical organizations.
- Ability to conduct live trainings for various team members
- Knowledge of healthcare privacy laws and obligations – US State and Federal Laws, HIPAA, GDPR, etc.
- Knowledge of healthcare laws and regulations, including the False Claims Act, Anti-Kickback Statute, Sunshine Act and US State Transparency Laws, FDCA, FCPA/UKBA, etc.
- Excellent analytical, organizational, and communication skills.
- Ability to work independently and as part of a team to achieve compliance objectives.
- Clear, concise, and persuasive verbal and written communication including presentation skills.
- This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, telephones, photocopiers, filing cabinets etc.
- 25-35% travel required (Domestic or International)
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
his is a generic vacancy template
About the Company Immunocore (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.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.