Description : 

DBV Technologies is seeking a detail-oriented Associate Medical Writer/QC Specialist to support the development of clinical trial documents and regulatory submissions. The ideal candidate will demonstrate writing experience and full quality control capabilities in developing clinical study reports, protocols, Investigator’s Brochures, DSURs, and related documents. This role focuses on scientific writing and meticulous document compilation.

The successful candidate will optimize SharePoint document organization, work efficiently under shortened deadlines, and communicate proactively with stakeholders to ensure adherence to established timelines. Additional responsibilities may be assigned depending on project needs and organizational priorities.

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

Salary Range : $85-110k

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.

• 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 2 years of medical writing and QC experience.

• Strong attention to detail with proven QC experience.

• Strong multi-tasking skills and proven ability to meet tight deadlines.

• Proficient in the Microsoft Office suite, reference databases, and SharePoint.

• Proficient in summarizing data from Tables, Figures, and Listings (TFLs).

• Excellent computer literacy and written communication skills.

• Good understanding of the drug development process.

• Familiarity with ICH-GCP guidelines and regulatory submission requirements (FDA, EMA).

• Preferred: Ability to interpret and organize complex scientific content into concise messages.

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.