Senior Staff Medical Writer (Remote)
Core
Lead clinical evidence strategies and scientific documentation to support regulatory submissions, market access, and product lifecycle decisions for medical devices.
Role type
Senior Staff Medical Writer (Regulatory/Clinical Evidence)
Builds
Regulatory submissions, clinical evaluations, post-market clinical follow-up documentation, scientific manuscripts, and evidence-based recommendations.
Domain
Medical Devices / Regulatory Affairs / Clinical Evidence
Required skills
Clinical evidence strategy, regulatory submissions, systematic literature reviews, evidence synthesis, benefit-risk assessment, scientific writing, cross-functional project management, mentorship
Preferred skills
Global regulatory requirements (ISO, FDA), complex cross-functional project management, market access activities
Technologies
None stated
Responsibilities
Lead clinical evidence strategies for new product development and lifecycle management; Manage clinical evaluation projects ensuring alignment with regulatory and commercial objectives; Author clinical evaluations, post-market documentation, and regulatory submissions; Design and execute systematic literature reviews and synthesize clinical/preclinical/post-market data; Assess benefit-risk profiles and develop evidence-based recommendations; Partner with regulatory authorities and internal stakeholders; Develop scientific communications including manuscripts and white papers; Mentor team members and improve clinical evaluation methodologies.
Seniority
Senior Staff, hands-on IC with mentorship responsibilities