Associate Medical Writer

DBV Technologies

. Support the development of clinical documents compliant with regulatory guidelines, including redlined versions and summary of changes documents .

Posted 11/4/2026full-timeWarren • New Jersey • United StatesJuniorMid-Level💰 $85,000 - $110,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing and quality control, ensuring compliance with regulatory guidelines while effectively summarizing complex scientific data. Proficient in document formatting, stakeholder communication, and maintaining adherence to project timelines.

Highest-signal resume keywords

Medical Writing ExperienceQuality Control (QC) ExpertiseRegulatory Compliance KnowledgeMicrosoft Office ProficiencyICH-GCP Familiarity

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Document FormattingData SummarizationSource-Document VerificationCross-ReferencingStatistical Output Interpretation

Soft Skills

Attention to DetailMulti-TaskingWritten Communication

Tools & Technologies

SharePointReference Databases

Certifications & Qualifications

GCP CertificationAMWA Certification

Industry Keywords

Life SciencesScientific CommunicationsDrug Development ProcessRegulatory Submission RequirementsFDAEMA

About the role

Key responsibilities & impact

Support the development of clinical documents compliant with regulatory guidelines, including redlined versions and summary of changes documents
Perform comprehensive QC reviews, including editorial, formatting, source-document verification, and data-consistency cross-referencing
Develop and maintain lists of abbreviations, references, appendices, and consistent document formatting and style
Format tables, figures, and cross-reference insertions
Incorporate reviewer feedback and lead comment adjudication meetings
Summarize statistical outputs into clear, regulatory-compliant narrative text
Adhere to document timelines and provide status updates to management
Optimize SharePoint document organization and communicate proactively with stakeholders

Requirements

What you’ll need

Bachelor’s degree in life sciences, scientific communications, or a related field
Minimum of 2 years of medical writing and QC experience
Strong attention to detail with proven QC experience
Strong multi-tasking skills and proven ability to meet tight deadlines
Proficient in the Microsoft Office suite, reference databases, and SharePoint
Proficient in summarizing data from Tables, Figures, and Listings (TFLs)
Excellent computer literacy and written communication skills
Good understanding of the drug development process
Familiarity with ICH-GCP guidelines and regulatory submission requirements (FDA, EMA)
Preferred: Advanced degree
Preferred: GCP or AMWA certification
Preferred: Ability to interpret and organize complex scientific content into concise messages