Medical Writer

DBV Technologies • Bernards, VA

11h • $105,000 - $130,000 • Hybrid

About The Position

DBV Technologies is seeking a skilled, detail-oriented Medical Writer to support development of clinical trial documents and regulatory submissions. The role focuses on scientific writing in accordance with regulatory guidelines. The Medical Writer will develop documents such as clinical study reports, protocols, Investigator’s Brochures, DSURs, BLA/NDAs, and related materials; work efficiently under shortened deadlines; communicate proactively with stakeholders to meet established timelines; and interpret and summarize efficacy and safety data in succinct, regulatory-compliant language. Additional responsibilities may be assigned based on project needs and organizational priorities. The position is based in Warren, New Jersey, and requires a minimum of three days onsite.

Requirements

• Bachelor’s degree in life sciences, scientific communications, or a related field.
• At least 4 years of medical writing experience.
• Good understanding of the drug development process.
• Good understanding of ICH-GCP guidelines and regulatory submission requirements, including FDA and EMA requirements.
• Ability to interpret and organize complex scientific content into concise messages.
• Proficiency in Microsoft Office and SharePoint.
• Excellent computer literacy and written communication skills.
• Strong attention to detail.
• Strong multitasking skills and demonstrated ability to meet tight deadlines.

Nice To Haves

• Advanced degree.
• GCP or AMWA certification.

Responsibilities

• Support development of clinical documents compliant with regulatory guidelines, including preparing redlined versions and summaries of changes as required.
• Perform comprehensive quality control reviews of deliverables, including editorial and formatting review, verification against source documents, and cross-referencing for data consistency.
• Develop and maintain document components such as lists of abbreviations, references, and appendices, and ensure consistent document formatting and style.
• Format documents, including tables, figures, and cross-reference insertions.
• Incorporate reviewer feedback and lead comment adjudication meetings.
• Summarize statistical outputs in clear, regulatory-compliant narrative text.
• Meet document timelines and provide status updates to management as requested.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level