Regulatory Medical Writer - Clinical Docs & Submissions NJ

DBV Technologies; Bernards Township (NJ); On-site; USD 105,000 - 130,000; Full time

Job summary

DBV Technologies is seeking a skilled Medical Writer to support the development of clinical trial documents and regulatory submissions. The role focuses on scientific writing in accordance with regulatory guidelines, with experience in creating clinical study reports, protocols, Investigator’s Brochures, DSURs, and regulatory submissions.

The successful candidate will read and summarize efficacy and safety data in concise, regulatory-compliant language, work under tight deadlines, and coordinate

Qualifications

• 4+ years of medical writing experience.
• Strong understanding of ICH-GCP guidelines and regulatory submission requirements (FDA, EMA).
• Ability to interpret complex scientific content into clear messages.

Responsibilities

• Support development of clinical documents compliant with regulatory guidelines.
• Perform QC reviews of deliverables, including formatting and data verification.
• Maintain document components such as abbreviations, references, and appendices.

Skills

Clinical writing

Regulatory writing

Attention to detail

Communication

Education

Bachelor’s in life sciences

Advanced degree preferred

Tools

Microsoft Word

SharePoint

Job description

DBV Technologies is seeking a skilled Medical Writer to support the development of clinical trial documents and regulatory submissions. The role focuses on scientific writing in accordance with regulatory guidelines, with experience in creating clinical study reports, protocols, Investigator’s Brochures, DSURs, and regulatory submissions.

The successful candidate will read and summarize efficacy and safety data in concise, regulatory-compliant language, work under tight deadlines, and coordinate