Principal Medical Writer preparing regulatory documents and medical communications for Veristat, a clinical research organization accelerating life-changing therapies.
Supporting product development through scientific analysis, ICH compliance, and cross-functional document collaboration.
Responsibilities
Independently plan and prepare regulatory documents and medical communications supporting all phases of product development
Organize, analyze, interpret, and present scientific and statistical information according to ICH and other regulatory guidelines
Prepare documents in accordance with company document standards
Work under the direction of Medical Writing management
Collaborate with cross-functional internal and external document production teams
Requirements
Bachelor’s degree required; science-related field preferred
Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting
Other professional and/or educational experience may contribute toward the minimum experience requirement on a case-by-case basis
Advanced knowledge of ICH and related regulatory guidelines
Excellent written English
Keen attention to detail
Strong interpersonal and communication skills
Experience with Microsoft Office Suite is essential
Benefits
Remote working
Flexible time off
Paid holidays
Medical insurance
Tuition reimbursement
Retirement plans
Applicable bonus
Inclusive culture
Reasonable accommodations and accessible application experience
Senior Medical Writer leading clinical regulatory and clinical document authorship for Veristat, a life - sciences consultancy accelerating therapies. Managing projects, teams, clients, and submission deliverables.
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