Senior Staff Medical Affairs Specialist

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $155.6k - $233.4k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Illumina

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1998

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $750M Post-IPO Debt on 2023-01

Healthcare • Consulting • Manufacturing

Illumina is a leading company in the genomics field, providing innovative technologies for the analysis of genetic variation and function. They offer a wide range of products and services, including sequencing platforms, microarray technology, library preparation kits, bioinformatics software, and comprehensive genomic solutions. Illumina's next-generation sequencing platforms are used for various research and clinical applications, such as cancer research, reproductive health, and genetic disease detection. The company is dedicated to improving human health by enabling researchers and clinicians to accelerate their genomic discoveries and applications, ultimately impacting precision medicine and life sciences globally.

📋 Description

• Serve as a Medical Affairs reviewer within the Content Approval Process (CAP) • Ensure scientific accuracy, medical appropriateness, evidence-based messaging, and compliance of materials related to Illumina, its products, and services • Provide medical and scientific guidance to Marketing, Commercial, Regulatory, Legal, and Compliance stakeholders • Support development and dissemination of compliant external and internal communications • Lead development, implementation, and continuous improvement of Medical Affairs review processes, SOPs, work instructions, and governance frameworks • Partner with global, regional, and segment-specific Medical Affairs teams on strategic initiatives • Identify process improvement opportunities and drive efficient execution of compliant Medical Affairs programs and communications • Support strategic planning and execution of global Medical Affairs initiatives involving medical review processes, compliant communications, content governance, and operational excellence • Provide training, mentorship, and consultation on compliant scientific communications and Medical Affairs best practices

🎯 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 reviewing and approving scientific, medical, and promotional materials • Strong understanding of applicable healthcare regulations, industry codes, and compliance requirements • Ability to evaluate complex scientific and clinical data and apply sound medical judgment • Deep understanding of Medical Affairs governance, content approval processes, quality systems, and document lifecycle management • Experience developing and implementing compliant review processes, SOPs, and work instructions • Ability to influence diverse cross-functional stakeholders without direct authority • Leadership in cross-functional initiatives, process improvements, and operational excellence programs within a global matrix environment • Excellent written and verbal communication skills • Strong analytical, organizational, and project management skills • Experience serving as a subject matter expert and providing training, mentorship, and consultation • Ability to work independently and exercise sound judgment in ambiguous situations • Genetic counselor experience preferred • Experience with formal Content Approval Process (CAP), Promotional Review Committee (PRC), Medical Review Committee (MRC), or similar governance framework preferred • Knowledge of diagnostic, genomics, molecular testing, biotechnology, medical device, or pharmaceutical industry regulations and standards preferred • Experience with content management, approval workflow, and document control systems preferred • Experience leading global process harmonization, inspection readiness, quality initiatives, or governance programs preferred • Experience developing training materials and leading stakeholder education preferred • Typically 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 able to work in the United States • This role is not eligible for visa sponsorship

🏖️ Benefits

• Variable cash program (bonus or commission) • Equity for eligible roles • Access to genomics sequencing • Family planning benefits • Health, dental, and vision benefits • Retirement benefits • Paid time off • Employee Resource Groups offering career development experiences, cultural awareness, and social responsibility opportunities • Accommodation support for the application or interview process