A company is looking for a Senior Specialist, Medical Writing.
Key Responsibilities
Support the development of regulatory and clinical documents for products across the Transcatheter Mitral and Tricuspid Therapies business unit
Conduct literature searches, extract clinical data, and write summaries for clinical evaluation and study reports
Review cross-functional deliverables and negotiate timelines and project-related issues with stakeholders
Required Qualifications
Bachelor's Degree in a related field with 5 years of experience in medical affairs, clinical affairs, or clinical science
Experience with literature reviews and publication databases such as PubMed and Embase
Familiarity with the cardiovascular therapeutic area and clinical research
Knowledge of scientific research methodology and relevant regulations (GCP, ICH, FDA, EU MDR)
Experience working in a collaborative, cross-functional environment
Senior Medical Writer • Raleigh, North Carolina, United States