Sr Staff Medical Affairs Specialist

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At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

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Position Summary:

The Senior Staff Medical Affairs Specialist in Global Medical & Scientific Affairs at Illumina is responsible for supporting the development, review, and approval of scientific and medical content to ensure accurate, balanced, and compliant communications regarding Illumina, its products, and services. This individual will serve as a key Medical Affairs reviewer within the Content Approval Process (CAP), partnering with cross-functional stakeholders to ensure materials are scientifically rigorous, consistent with approved evidence, and compliant with applicable policies, procedures, and regulations. This position reports to the Global Medical Affairs Core Operations Leader.

Success in this role requires excellent oral and written communication skills, strong scientific knowledge, sound medical judgment, and the ability to critically evaluate, compile, and synthesize complex medical and scientific information. The individual must be able to collaborate effectively across global, regional, and segment-specific teams while balancing business needs with compliance requirements.

This individual will work closely with the Global Medical Affairs Core Operations Leader to support strategic planning and execution of key global Medical Affairs initiatives related to medical review processes, compliant communications, content governance, and operational excellence. The role will partner with global, regional, and segment-specific Medical Affairs team members, Legal, Regulatory, Compliance, Marketing, and other cross-functional stakeholders to enable timely and compliant review and approval of materials.

This position requires an experienced professional with established scientific credibility and the ability to influence and collaborate with internal and external stakeholders in a highly visible environment. The individual will support the development, implementation, and continuous improvement of compliant processes, standard operating procedures, work instructions, and quality systems related to Medical Affairs review activities. Strong analytical skills, attention to detail, and a passion for driving efficiency, quality, and compliance while serving as a good steward of Illumina resources are essential for success in this role.

Position Responsibilities:

• Serve as a Medical Affairs reviewer within the Content Approval Process (CAP), ensuring scientific accuracy, medical appropriateness, evidence-based messaging, and compliance of materials related to Illumina, its products, and services.

• Provide medical and scientific guidance to cross-functional stakeholders, including Marketing, Commercial, Regulatory, Legal, and Compliance, to support the development and dissemination of compliant external and internal communications.

• Lead the development, implementation, and continuous improvement of Medical Affairs review processes, standard operating procedures (SOPs), work instructions, and governance frameworks that support quality, consistency, and operational excellence.

• Partner with global, regional, and segment-specific Medical Affairs teams to support strategic initiatives, identify process improvement opportunities, and drive efficient execution of compliant Medical Affairs programs and communications.

Listed responsibilities are an essential, but not an exhaustive, lists of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements: 

• Advanced degree in a life sciences field (PhD, MS/certified genetic counselor, or equivalent) with 8+ years of relevant industry experience in Medical Affairs, Medical Information, Scientific Communications, Medical Review, Clinical Affairs, Regulatory Affairs, or related functions.

• Demonstrated expertise in the review and approval of scientific, medical, and promotional materials, with a strong understanding of applicable healthcare regulations, industry codes, and compliance requirements governing medical and commercial communications.

• Proven ability to independently evaluate complex scientific and clinical data and apply sound medical judgment to ensure communications are accurate, balanced, evidence-based, and aligned with approved indications, claims, and intended use.

• Deep understanding of Medical Affairs governance, content approval processes, quality systems, and document lifecycle management, including experience developing and implementing compliant review processes, standard operating procedures (SOPs), and work instructions.

• Ability to influence and build alignment among diverse stakeholders, including Medical Affairs, Marketing, Commercial, Regulatory Affairs, Legal, Compliance, Clinical Affairs, and Product Management teams, often without direct authority.

• Demonstrated leadership in driving cross-functional initiatives, process improvements, and operational excellence programs within a global matrix environment.

• Excellent written and verbal communication skills, including the ability to provide clear scientific rationale, effectively communicate risk, and influence decision-making among senior leaders and cross-functional partners.

• Strong analytical, organizational, and project management skills with the ability to manage multiple priorities, assess business impact, and drive timely resolution of complex issues.

• Experience serving as a subject matter expert and providing training, mentorship, and consultation on compliant scientific communications, medical review standards, and Medical Affairs best practices.

• Ability to work independently and exercise sound judgment in ambiguous situations while balancing scientific integrity, compliance requirements, operational efficiency, and business objectives.

All listed requirements are deemed essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Preferred Experience/Education:

• Genetic counselor experience is preferred

• Experience serving as a Medical Affairs reviewer within a formal Content Approval Process (CAP), Promotional Review Committee (PRC), Medical Review Committee (MRC), or similar governance framework.

• Knowledge of diagnostic, genomics, molecular testing, biotechnology, medical device, or pharmaceutical industry regulations and standards.

• Experience with content management systems, approval workflow platforms, and document control systems.

• Demonstrated success leading global process harmonization, inspection readiness, quality initiatives, or governance programs.

• Experience developing training materials and leading stakeholder education related to compliant communications and Medical Affairs review processes.

Experience/Education:

• Typically requires a minimum of 12 years of related experience with a Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years of experience; or equivalent experience.

#LI-REMOTE

The estimated base salary range for the Sr Staff Medical Affairs Specialist role based in the United States of America is: $155,600 - $233,400. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long‑term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.