Associate Director, Healthcare Compliance at Immunocore in Gaithersburg, Maryland

Job Description:

Vacancy Name

Associate Director, Healthcare Compliance

Vacancy No

VN497

Employment Type

Full Time

Location of role

Gaithersburg, MD, US, Conshohocken, PA, US

Department

Legal

Key Responsibilities

MAIN PURPOSE OF JOB


Reporting to the Vice President, Compliance, the Associate Director, Compliance will serve an important role in Immunocore's continued enhancement of its Compliance program. This position will provide a broad range of compliance support and work to assist in the implementation, maintenance, and continued improvement of Immunocore's compliant and ethical practices and behaviors through close collaboration with internal and external business partners.


The incumbent is expected to be recognized as an emerging expert, advisor, and subject matter expert across the company in the field of healthcare compliance and to be able to interpret internal or external business challenges and recommending best practices or identifying new solutions.


The Associate Director, Compliance will also have primary responsibility for executing key elements of Immunocore's U.S. Compliance program and ensuring compliance with all applicable laws and guidance.


KEY RESPONSIBILITIES


General
* Help identify new work processes, tools or resources that will have broad applicability throughout the organization and assist with the implementation of Compliance systems and processes
* Provide training to internal and external organizational clients on a broad range of topics including anti-bribery, FDA regulations, transparency reporting and company policies
* Assist in the development and maintenance of relevant Standard Operating Procedures, work instructions, and guidance documents related to key areas within Compliance
Transparency Reporting
* Oversee data collection and generation of US and global transparency reports and subsequent reporting of transparency reports to applicable authorities
* Maintains understanding of disclosure laws, regulations and applicable industry codes
Auditing & Monitoring
* Perform auditing and monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations and company policies
* Review of Medical and Commercial documentation to ensure compliance with company SOPs and policies


* Partner with cross-functional colleagues to address detected noncompliance, including corrective actions when needed


Other


PERSON SPECIFICATION


Experience & knowledge


Essential
* Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including global aggregate spend and other reporting/sunshine laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing and price reporting compliance laws
* Experience with US and global transparency reporting
* Experience developing and executing audits and monitoring
* Strong operational and project management skills required
* Excellent organization, communication and presentation skills. Candidate must have strong team orientation and problem-solving skills
* Candidate must be able to work independently and prioritize multiple demands
Desirable
* Experience with creating and delivering compliance training for field team and home office colleagues
* Experience with participating in compliance investigations


KEY BEHAVIOURAL ATTRIBUTES


* Openness and honesty
Readily offering information pertaining to work in hand whether positive or negative.
* Taking responsibility
Being prepared to accept full responsibility for tasks entrusted to them; seeing tasks through to completion and dealing with the consequences of failure or success.
* Flexibility
Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively.
* Team spirit
Being able to work productively with others to achieve tasks. Showing consideration for the needs and feelings of others.


SPECIFIC BEHAVIOURAL ATTRIBUTES


* Attention to Communication: Ensuring information and work is passed on correctly and in a timely way to those who depend on it.
* Written & Oral Communication: Writing and speaking clearly to share thoughts and information concisely and appropriately.
* Diagnostic Information Gathering: Identifying the information required to clarify a situation, asking questions when required.
* Results Orientated: Focusing on desired results, seeking help and support to overcome obstacles in a timely manner.
* Thoroughness: Ensuring work and information provided is complete, carefully checking and seeking additional support to help achieve this if needed.
* Managing Self Performance: Works to specific and measurable goals, seeking support and advice when dealing with unfamiliar or new issues.
* Analytical Thinking: Tackling day -to-day problems using a logical and systematic approach, identifying discrepancies and inconsistencies.


Education & qualifications
* Requires a B.A./B.S. degree or equivalent (Advanced degree preferred) with 7+ years in compliance, audit and/or other related experience required. Pharmaceutical experience required
* Certified in Healthcare Compliance (CHC) a plus


Other
* This position requires 25% travel
* This role is based in our Conshohocken, PA office. Our office-based employees follow a hybrid schedule of 4-5 days in the office.

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.