Senior Staff Medical Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a Medical Affairs reviewer within the Content Approval Process (CAP)

• Ensure the scientific validity, medical relevance, evidence-based messaging, and compliance of materials related to Illumina, its products, and services

• Offer medical and scientific advice to Marketing, Commercial, Regulatory, Legal, and Compliance teams

• Assist in the development and distribution of compliant communications for both external and internal audiences

• Lead the creation, implementation, and ongoing enhancement of Medical Affairs review processes, SOPs, work instructions, and governance frameworks

• Collaborate with global, regional, and segment-specific Medical Affairs teams on strategic projects

• Identify opportunities for process improvements and facilitate the efficient execution of compliant Medical Affairs programs and communications

• Support strategic planning and the execution of global Medical Affairs initiatives that involve medical review processes, compliant communications, content governance, and operational excellence

• Provide training, mentorship, and consultation on compliant scientific communications and best practices in Medical Affairs

⛳️ Requirements

• An advanced degree in a life sciences discipline (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 fields

• Proven experience in reviewing and approving scientific, medical, and promotional materials

• Strong comprehension of healthcare regulations, industry standards, and compliance mandates

• Ability to assess complex scientific and clinical data and apply sound medical judgment

• Profound knowledge of Medical Affairs governance, content approval processes, quality systems, and document lifecycle management

• Experience in developing and implementing compliant review processes, SOPs, and work instructions

• Capability to influence diverse cross-functional stakeholders without direct authority

• Leadership experience in cross-functional initiatives, process enhancements, and operational excellence programs within a global matrix environment

• Exceptional written and verbal communication abilities

• Strong analytical, organizational, and project management skills

• Experience as a subject matter expert providing training, mentorship, and consultation

• Ability to work autonomously and exercise sound judgment in ambiguous situations

• Genetic counselor experience is preferred

• Familiarity with formal Content Approval Process (CAP), Promotional Review Committee (PRC), Medical Review Committee (MRC), or similar governance frameworks is preferred

• Knowledge of regulations and standards in the diagnostic, genomics, molecular testing, biotechnology, medical device, or pharmaceutical industries is preferred

• Experience with content management, approval workflows, and document control systems is preferred

• Experience leading global process harmonization, inspection readiness, quality initiatives, or governance programs is preferred

• Experience in developing training materials and facilitating stakeholder education is preferred

• Generally requires 12 years of related experience with a bachelor’s degree; or 8 years with a master’s degree; or a PhD with 5 years of experience; or equivalent experience

• Must be eligible to work in the United States

• This position is not eligible for visa sponsorship

🏝️ Benefits

• Variable cash program (bonus or commission)

• Equity opportunities for eligible roles

• Access to genomics sequencing

• Family planning benefits

• Health, dental, and vision insurance

• Retirement benefits

• Paid time off

• Employee Resource Groups that provide career development experiences, cultural awareness, and opportunities for social responsibility

• Accommodation support for the application or interview process