Medical Writer & QC Specialist — Clinical Trials

DBV Technologies; Bernards Township (NJ); Hybrid; USD 85,000 - 110,000; Full time

Job summary

DBV Technologies seeks a detail-oriented Associate Medical Writer/QC Specialist to support clinical trial documents and regulatory submissions. You will ensure full QC of SARs, protocols, and DSURs, with meticulous document compilation and SharePoint organization.

The role focuses on scientific writing, with tight deadlines and proactive stakeholder communication to ensure timelines are met. On-site presence in Warren, NJ is required.

Qualifications

• Bachelor’s degree in life sciences, scientific communications, or related field.
• Advanced degree preferred.
• GCP or AMWA certification preferred.
• Minimum of 2 years medical writing and QC experience.
• Strong attention to detail with proven QC experience.
• Strong multi-tasking skills and ability to meet tight deadlines.
• Proficient in Microsoft Office, reference databases, and SharePoint.
• Proficient in summarizing data from Tables, Figures, and Listings (TFLs).
• Excellent written communication and drug development understanding.
• Familiarity with ICH-GCP and regulatory submission requirements.

Responsibilities

• Support development of regulatory-compliant documents.
• Perform QC reviews of deliverables for editorial and formatting accuracy.
• Develop and maintain abbreviations lists, references, and appendices.
• Format documents including tables, figures, and cross-references.
• Incorporate reviewer feedback and lead adjudication meetings.
• Summarize statistical outputs into regulatory narratives.
• Adhere to timelines and provide status updates to management.

Skills

Medical writing

QC experience

Attention to detail

Time management

Written communication

SharePoint

MS Office

Data summarization

Education

Bachelor’s degree in life sciences

Advanced degree

GCP or AMWA certification

Tools

SharePoint

Reference databases

Job description

DBV Technologies seeks a detail-oriented Associate Medical Writer/QC Specialist to support clinical trial documents and regulatory submissions. You will ensure full QC of SARs, protocols, and DSURs, with meticulous document compilation and SharePoint organization.

The role focuses on scientific writing, with tight deadlines and proactive stakeholder communication to ensure timelines are met. On-site presence in Warren, NJ is required.