Senior Medical Writer - clinical focus

About the role

The Senior Medical Writer- Clinical Focus is a major contributor to document authorship for a variety of documents across different service lines. The Sr Medical Writer will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team. Veristat is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals.

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide:

• 105+ approved therapies for marketing applications prepared by Veristat
• 480+ oncology projects in the past 5 years
• 350+ rare disease projects delivered in the past 5 years
• Flexible, inclusive culture — 70% remote workforce, 66% women-led teams

Responsibilities

• Lead internal project teams and interface directly with clients
• Develop submission-level documents (e.g., Clinical Study Reports, Investigator Brochures, protocols, ISS, ISE)
• Synthesize data across multiple sources to create summary reports
• Conduct/lead Clinical Research Meetings (CRM) and drive project teams to consensus
• Use logical arguments to persuade others and respond positively to opposing views
• Develop professional client relationships to further business and maintain industry knowledge
• Identify and institutionalize effective work practices for consistent performance

Requirements

• Bachelor’s degree or higher in a scientific discipline (strongly preferred)
• 3+ years of regulatory writing experience or equivalent experience with clinical-related documentation
• Understanding of regulatory authority guidelines and requirements
• Experience in the development of clinical documents such as Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE

Skills & Abilities

• Intermediate proficiency with Microsoft Word (editing tools, tables, figures) and document management techniques
• Strong understanding of the document creation process and drug development lifecycle
• Ability to synthesize data from multiple sources
• Strong interpersonal and persuasion skills

Benefits

• Remote working options
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

Pay

The estimated hiring range for this role is $116K–128K plus applicable bonus (US-specific; varies by region based on local market data). Final salary is determined by skills, experience, licensure, education, location, and dynamic market factors.