Principal Medical Writer – CMC Focus

Veristat

. Prepare high-quality regulatory documentation for client submissions .

Posted 10/2/2026full-timeRemote • Massachusetts • United States, CanadaLead💰 $132,000 - $151,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory document preparation and project leadership, with a strong focus on Modules 3 and 2.3, while maintaining compliance with global health authority requirements. Proven ability to mentor teams, build client relationships, and implement effective work practices in high-pressure environments.

Highest-signal resume keywords

Regulatory Writing ExperienceModules 3 And 2.3 AuthoringProject LeadershipClient Relationship ManagementDocument Preparation Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory DocumentationChemistry Manufacturing And ControlsNDA ExperienceIND ExperienceBLA ExperienceIMPD ExperienceDocument Management TechniquesData SynthesisQuality Document PreparationDrug Development Lifecycle

Soft Skills

Time ManagementOrganizational SkillsProblem ResolutionMentoringCommunication Best Practices

Tools & Technologies

Microsoft Word

Industry Keywords

Global Health Authority RequirementsRegulatory Authority GuidelinesBiologicsGene TherapyCell TherapyVaccinesSmall MoleculeAnalyticalStability

About the role

Key responsibilities & impact

Prepare high-quality regulatory documentation for client submissions
Contribute to authorship of documents across different service lines
Lead projects and author regulatory documents for client engagements
Mentor others in regulatory document authoring
Author and lead Modules 3 and Module 2.3
Serve as document lead for submission-level documents
Provide subject matter guidance on document preparation, review, comment resolution, and finalization
Lead project teams toward goals within timelines and budgets
Build professional client relationships and support business relationships
Identify and institutionalize effective work practices
Resolve sensitive or high-pressure project problems
Transfer knowledge across the organization

Requirements

What you’ll need

Bachelor’s degree or higher, scientific discipline strongly preferred
7+ years of regulatory writing experience with Chemistry, Manufacturing, and Controls documentation
Experience in vaccines, gene/cell therapy, biologics, small molecule, manufacturing, analytical, or stability
Experience with NDAs, INDs, BLAs, or IMPDs
Experience authoring and leading Modules 3 (e.g., Modules 3.2.S and 3.2.P) and Module 2.3
Understanding of regulatory authority guidelines and requirements
Ability to lead a project team
Understanding of regulatory requirements for different phases of development and regulatory pathways
Knowledge of global health authority requirements
Experience as a document lead in submission-level documents
Intermediate proficiency with Microsoft Word, including editing tools, creating and modifying tables, inserting figures, and document management techniques
Strong understanding of document creation processes and the drug development lifecycle
Ability to synthesize data across multiple sources and documents to create summary reports
Expertise in quality document preparation, document review, comment resolution/incorporation, and document finalization
Ability to own submission-level documents and lead others toward common goals within timelines and budgets
Understanding of communication best practices
Solid time management and organizational skills
Ability to develop professional client relationships and maintain current industry knowledge
Ability to identify and institutionalize effective work practices
Ability to resolve problems in sensitive or high-pressure situations
Ability to transfer knowledge and strengthen organizational capabilities

Benefits

Comp & perks

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