Medical Writer

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

Description :

DBV Technologies is seeking a skilled and detail-oriented Medical Writer to support the development of clinical trial documents and regulatory submissions. This role focuses on scientific writing in accordance with regulatory guidelines. The ideal candidate has extensive writing experience developing clinical study reports, protocols, Investigator’s Brochures, DSURs, regulatory submissions (BLA/NDAs), and related documents.

The successful candidate will work efficiently under shortened deadlines, communicate proactively with stakeholders to ensure adherence to established timelines, and be able to read and summarize efficacy and safety data in succinct, regulatory-compliant language. Additional responsibilities may be assigned depending on project needs and organizational priorities.

Location :Warren, New Jersey - minimum 3 days on site

Salary Range :$105-130k

Key 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.

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.

Behavioral skills :

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.