Job Description

DUTIES & RESPONSIBILITIES
The Pre-Clinical Senior Medical Writer serves as the clinical and scientific subject matter expert (SME) supporting the development of pre-clinical research publications. This role provides strategic scientific oversight and quality review of manuscripts authored by medical writers, ensuring scientific accuracy, clinical relevance, publications readiness, and alignment with current cardiovascular practice.

PRIMARY RESPONSIBILITIES:
• Serve as the primary clinical expert for pre-clinical research publications.
• Provide clinical interpretation of study findings and assess their potential relevance to patient care and future clinical application.
• Advise teams on cardiovascular disease states, treatment pathways, current standards of care, and emerging technologies.
• Support publication strategy for cardiovascular device portfolio.
• Perform comprehensive scientific and clinical review of manuscript drafts developed by medical writers.
• Identify gaps, inconsistencies, and unsupported claims.
• Ensure manuscripts are suitable for submission to high-impact peer-reviewed journals.
• Collaborate with medical writers during publication planning and manuscript development.
• Participate in author meetings and publication review discussions.
• Participates in creation of medical training materials and programs that are used to support initial and ongoing training for new employees (e.g., medical writers).
• Act as backup medical writer.

ROLE REQUIREMENTS:
• At least 5 years of clinical, scientific, or medical writing experience.
• Experience reviewing scientific manuscripts for journals, industry sponsors, CROs, academic institutions, or medical device manufacturers.
• Experience interpreting pre-clinical, translational, and clinical study data.
• Familiarity with FDA, EU MDR, and global medical device regulatory requirements.
• Experience working within a CRO, medical device manufacturer academic research organization, or cardiovascular research center.

EDUCATIONAL QUALIFICATIONS:
• MD, DO, MBBS, or equivalent medical degree.
• Board certification or specialty training in a cardiovascular discipline is preferred.