Onsite Regulatory Medical Writer — Clinical Submissions

DBV Technologies; Virginia; 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. This role focuses on scientific writing in accordance with regulatory guidelines, including clinical study reports, protocols, Investigator’s Brochures, DSURs, and FDA/EMA submissions.

The successful candidate will read and summarize efficacy and safety data in regulatory-compliant language, work under tight deadlines, and collaborate with stakeholders.

Qualifications

• Bachelor’s degree in life sciences, scientific communications, or a related field.
• Preferred: Advanced degree.
• Preferred: GCP or AMWA certification.
• 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.

Responsibilities

• Support the development of clinical documents that are compliant with regulatory guidelines, including preparation of redlined versions and summary of changes documents as required.
• Perform comprehensive quality control (QC) reviews of deliverables, including editorial, formatting, verification against source documents, and cross-referencing data consistency as needed.
• Develop and maintain document components such as lists of abbreviations and references and appendices, and ensure consistent formatting and style throughout documents.
• Format documents (e.g., tables, figures, cross-reference insertions).
• Effectively incorporate reviewer feedback and lead comment adjudication meetings.
• Summarize statistical outputs into clear, regulatory-compliant narrative text.
• Adhere to timelines for each document and provide status updates to management as requested.

Education

Bachelor’s degree in life sciences

Advanced degree

GCP or AMWA certification

Job description

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

The successful candidate will read and summarize efficacy and safety data in regulatory-compliant language, work under tight deadlines, and collaborate with stakeholders.