Medical Writer

DBV Technologies; EE. UU.; Presencial; USD 105.000 - 130.000; Jornada completa

Descripción de la vacante

DBV Technologies is seeking a skilled Medical Writer to support clinical trial documents and regulatory submissions. You will translate efficacy and safety data into regulatory-compliant language and coordinate with stakeholders to meet deadlines. Warren, NJ on-site position with a salary range of $105k–$130k.

The role requires at least 4 years of medical writing experience, a life sciences background, and proficiency in MS Office and SharePoint. GCP/AMWA certification is preferred.

Formación

• Bachelor’s degree in life sciences or related field.
• Minimum of 4 years of medical writing experience.
• Strong understanding of ICH-GCP guidelines and regulatory submissions.
• Proficient in MS Office and SharePoint.

Responsabilidades

• Support development of clinical documents compliant with regulatory guidelines.
• Perform comprehensive quality control reviews of deliverables.
• Develop and maintain document components with consistent formatting.
• Format documents including tables and figures.
• Incorporate reviewer feedback and lead comment adjudication meetings.
• Summarize statistical outputs into regulatory-compliant narrative text.
• Meet tight timelines and provide status updates to management.

Conocimientos

Medical writing

Regulatory submissions

GCP/AMWA certification

Life sciences background

Educación

Bachelor’s degree in life sciences

Advanced degree

Herramientas

Microsoft Office

SharePoint

Descripción del empleo

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 siteSalary 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.