Regulatory Medical Writer & QC Specialist

DBV Technologies; United States; On-site; USD 85,000 - 110,000; Full time

Job summary

DBV Technologies is seeking an Associate Medical Writer/QC Specialist to support clinical trial documents and regulatory submissions. The role emphasizes scientific writing, meticulous document compilation, and SharePoint organization to meet tight deadlines.

Minimum 2 years of medical writing and QC experience are required. A Bachelor’s in life sciences is essential; advanced degrees and GCP/AMWA certifications are a plus. This is an on-site role in Warren, NJ, with salary range $85-110k.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Advanced degree preferred.
• GCP or AMWA certification preferred.
• Minimum 2 years of medical writing and QC experience.
• Strong attention to detail with proven QC experience.
• Proficient in Microsoft Office, reference databases, and SharePoint.
• Proficient in summarizing data from Tables, Figures, and Listings (TFLs).
• Excellent written communication and understanding of drug development processes.
• Familiarity with ICH-GCP guidelines and regulatory submission requirements (FDA, EMA).
• Ability to interpret and organize complex scientific content into concise messages.

Responsibilities

• Support development of clinical documents compliant with regulatory guidelines, including redlined versions and summary of changes.
• Perform comprehensive QC reviews of deliverables (editorial, formatting, data checks).
• Develop and maintain document components such as abbreviations lists, references, and appendices with consistent formatting.
• Format documents (tables, figures, cross-references).
• Incorporate reviewer feedback and lead comment adjudication meetings.
• Summarize statistical outputs into regulatory narrative text.
• Adhere to timelines and provide status updates to management.

Skills

Attention to detail

QC experience

Multi-tasking

Written communication

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

SharePoint

Microsoft Office

Reference databases

Job description

DBV Technologies is seeking an Associate Medical Writer/QC Specialist to support clinical trial documents and regulatory submissions. The role emphasizes scientific writing, meticulous document compilation, and SharePoint organization to meet tight deadlines.

Minimum 2 years of medical writing and QC experience are required. A Bachelor’s in life sciences is essential; advanced degrees and GCP/AMWA certifications are a plus. This is an on-site role in Warren, NJ, with salary range $85-110k.