Remote Medical writing Jobs · Project Management

• Support clinical trial recruitment and site outreach.
• Establish and cultivate scientific relationships with KOLs in the Duchenne community.
• Serve as a resource for addressing unsolicited medical questions about REGENXBIO’s trials and investigational products.

Provide oversight of assigned clients, including implementation and ongoing management. Understand client needs and ensure deliverables meet expectations and KPIs. Triage and respond to medical information inquiries from healthcare professionals, consumers, and payers.

This position requires a strong candidate with expertise in the analysis of medical literature, data from clinical trials and pre-clinical studies, and sound knowledge of applicable regulations and standards. The position will mainly focus on the development of Clinical Evaluation Plans (CEPs) & Clinical Evaluation Reports (CERs). The purpose of this job is to collaboratively develop strategies for the creation of CEPs followed by the development of clinical evaluation reports (CERs) per EU MDR, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, re-certification and proposed indication/labeling changes.