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 StatesMid-LevelSenior💰 $105,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing with a strong understanding of regulatory guidelines and the drug development process. Proficient in producing high-quality clinical documents while adhering to timelines and incorporating feedback effectively.

Highest-signal resume keywords

Medical Writing ExperienceRegulatory Submission RequirementsICH-GCP GuidelinesMicrosoft Office ProficiencyAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Document DevelopmentQuality Control ReviewsStatistical Output SummarizationDocument FormattingSource-Document Verification

Soft Skills

Written Communication SkillsMulti-Tasking Skills

Tools & Technologies

Microsoft Office SuiteSharePoint

Certifications & Qualifications

GCP CertificationAMWA Certification

Industry Keywords

Drug Development ProcessRegulatory GuidelinesFDAEMAScientific Communications

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 quality control reviews of deliverables, including editorial, formatting, source-document verification, and cross-referencing data consistency.
Develop and maintain lists of abbreviations, references, appendices, and other document components.
Ensure consistent formatting and style throughout documents.
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.

Requirements

What you’ll need

Bachelor’s degree in life sciences, scientific communications, or a related field.
Minimum of 4 years of medical writing experience.
Good understanding of the drug development process.
Good understanding of ICH-GCP guidelines and regulatory submission requirements (FDA, EMA).
Ability to interpret and organize complex scientific content into concise messages.
Proficient in the Microsoft Office suite and SharePoint.
Excellent computer literacy and written communication skills.
Strong attention to detail.
Strong multi-tasking skills and proven ability to meet tight deadlines.
Preferred: Advanced degree.
Preferred: GCP or AMWA certification.