Medical Affairs

OverviewA mid-sized, biopharmaceutical company with a focus on nephrology is enhancing its Medical Affairs capabilities to support ongoing clinical and commercial growth. The organization seeks a medical writing leader to play a pivotal role in guiding the function to translate complex clinical and scientific data into clear, actionable insights across research, education, regulatory, and external engagement functions.Key ResponsibilitiesData Review & Message Development - Oversee the analysis of clinical and scientific information, extraction of key insights, and development of consistent scientific messaging across internal and external documents.Scientific Communications and Publications – Lead the creation and review of abstracts, posters, manuscripts, slide decks, and other scientific materials for both internal and external use.Medical Information and Education – Direct the development of standard response letters, accurate responses to medical inquiries, medical review processes, and educational initiatives for healthcare providers and payers. Regulatory and Clinical Writing – Provide strategic support for protocols, study reports, regulatory submissions, and related documentation. External Engagements and Insights – Represent the company in scientific discussions with key opinion leaders (KOLs), payers, physicians, and patient organizations, while capturing insights to inform company strategy. Qualifications • Advanced degree (PharmD, PhD, or MD) required. • 5–8 years of experience in pharmaceutical or biotech Medical Affairs. • Proven expertise in medical writing, medical information, and stakeholder engagement. • Strong understanding of the therapeutic area (e.g., nephrology, endocrinology, or related). • Demonstrated success in scientific publication development and KOL engagement. • Excellent communication, analytical, and project management skills. • Familiarity with GCP, GPP, and relevant regulatory standards.