Omaira Nesbit, Pharm.D.

Associate Director, Content Approval for Specialty/General Medicine @ GSK

About

Strategic, Bilingual, Associate Director of Medical Information and Promotional/Medical Review with expertise in developing compliant, innovative, and scientifically rigorous content that empowers healthcare providers and enhances patient care. Experience across Rheumatology, Immunology, Respiratory, Renal, Neuroscience, Cardiovascular and Oncology therapeutic areas. Known for bridging the gap between science and strategy through collaboration with Medical, Legal, Regulatory and Commercial teams to deliver data-driven messaging that support product success. Recognized for leadership, cross-functional influence, fostering high-performing team culture and delivering impactful medical communications that elevate brand awareness and strengthen healthcare provider engagement, while upholding a strong focus and commitment to compliance, integrity, and patient-centered solutions. Fluent in Spanish and English. Medical and Promotional Review (MMRT/CRC) | Scientific Accuracy and Claim Substantiation Regulatory and FDA Compliance | Scientific Content Development | Medical Communications Strategy Medical/Promotional Review Technology (MedComms/ Veeva PromoMats) |Cross-Functional Team Leadership Creative Problem Solving | Written and Verbal Communication

Country

United States

City

Wilmington

Industry

Pharmaceuticals

Skill

Creative Problem Solving, Training and Mentorship, Product Labeling, Strategic Medical Communications, Scientific Content Development, Data Analysis and Interpretation (clinical studies, outcomes, RWE), Cross-Functional Collaboration (Medical, Legal, Regulatory, Commercial), Scientific Communications, Medical Affairs Strategy, Regulatory Compliance, Promotional Review (MLR/PRC/PMRC), Medical Content Review, Healthcare Provider Engagement

Experience

Associate Director, Content Approval for Specialty/General Medicine

GSK

2026-1 - Present · 9 mos

United States

Associate Director, Medical Information and Communications

AstraZeneca

2014-3 - 2025-5 · 11 yrs 3 mos

Wilmington, Delaware, United States

Served as the Lead Medical Information (MI)/Medical reviewer on cross-functional review teams, ensuring the scientific and medical accuracy of branded and unbranded materials and compliance with FDA, regulatory, and company standards.

Associate Director, Global Regulatory Affairs

AstraZeneca

2000-7 - 2014-2 · 13 yrs 8 mos

Wilmington, DE

Implemented global regulatory strategies for pipeline and marketed products in North America, Europe, Japan, China and Emerging Markets. Managed US and global submissions, FDA meetings, labeling updates and advisory committee preparations.