Senior Medical Writer – Clinical Focus

Veristat

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.

Posted 8/13/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $116,000 - $128,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory writing and clinical documentation, including the development of submission-level documents and clinical study reports. Possesses strong client relationship management skills and the ability to synthesize data from multiple sources to support project delivery.

Highest-signal resume keywords

Regulatory Writing ExperienceClinical Study Report DevelopmentSubmission-Level Document DevelopmentMicrosoft Word ProficiencyUnderstanding of Regulatory Authority Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory WritingClinical DocumentationSubmission-Level Document DevelopmentClinical Study ReportsInvestigator BrochuresProtocolsISSISEData SynthesisDocument Management Techniques

Soft Skills

Client Relationship DevelopmentLogical ArgumentationConsensus BuildingConstructive Response to Opposing ViewsEffective Work Practices Identification

Tools & Technologies

Microsoft Word

Industry Keywords

Regulatory Authority GuidelinesDrug Development LifecycleClinical Research Management

About the role

Key responsibilities & impact

Contribute to authorship of clinical and regulatory documents across different service lines
Lead smaller projects as project lead and interface directly with clients
Support larger, more complex engagements as part of a larger delivery team
Lead internal project teams and anticipate the effects of writing conventions on health authority approval or acceptance
Develop submission-level documents
Develop clinical documents such as Clinical Study Reports, Investigator Brochures, protocols, ISS, and ISE
Synthesize data across multiple sources and documents to create summary reports
Conduct or lead a CRM and lead project teams to consensus
Present ideas and suggestions using logical arguments while responding constructively to opposing views
Develop professional client relationships to support business relationships and maintain industry knowledge
Identify and institutionalize effective work practices to ensure consistent performance

Requirements

What you’ll need

Bachelor’s degree
3+ years of regulatory writing experience or equivalent experience with clinical-related documentation
Understanding of regulatory authority guidelines and requirements
Experience developing submission-level documents
Experience developing Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE
Intermediate proficiency with Microsoft Word, including editing tools, creating and modifying tables, and inserting figures
Knowledge of document management techniques
Strong understanding of the document creation process and drug development lifecycle
Ability to synthesize data across multiple data sources and documents
Ability to conduct or lead a CRM and lead a project team to consensus
Ability to use logical arguments to persuade others and respond positively to opposing views
Ability to develop professional client relationships
Ability to identify and institutionalize effective work practices

Benefits

Comp & perks

Remote working
Flexible time off
Paid holidays
Medical insurance
Tuition reimbursement
Retirement plans
Applicable bonus