Company Overview

DBV Technologies is a global, clinical-stage biopharmaceutical company founded by pediatricians who believe that food allergies could one day be effectively treated.

We have made it our mission to advance epicutaneous immunotherapy by using our innovative technology platform, Viaskin™ to develop therapeutic alternatives for immunological diseases with significant unmet medical needs.

This mission is the driving force behind our commitment to advancing treatments for patients and their families. That's why we are researching a potential new class of immunotherapy, epicutaneous immunotherapy (EPIT™), whose goal is to retrain patients' immune systems through the skin.

Position Summary

The Medical Writer is responsible for the development of documents pertaining to clinical studies and regulatory submissions, including but not limited to clinical trial protocols, clinical study reports (CSRs), Investigator Brochures, regulatory briefing documents, and summaries for marketing applications.

The Medical Writer must have thorough understanding of the principles of scientific/medical writing and demonstrate expertise in relevant regulatory requirements.

This person will have the ability to analyze and interpret data in order to convey messages clearly and concisely and ensure consistency across documents.

The Medical Writer will identify appropriate members for the writing team relevant to each project and be able to manage collaborations on cross-functional initiatives.

Main Responsibilities

Independently author high-quality documents compliant with internal processes and external requirements (ICH/GCP/regulatory guidelines)
Demonstrate subject matter expertise
Review and edit sections of documents written by other team members (internal or external) assuring quality of writing and consistency within document
Ability to easily manipulate/format documents, including appropriate referencing and insertion of tables/figures
Provide overall project management for each document, including developing and maintaining project timelines
Ensure scientific accuracy and oversee quality control of document (editorial and fact-checking)

Required Skills

Good understanding of the drug development process and knowledge of Pharmaceutical Industry
Knowledge and experience of GCP/ICH practice, and the regulatory and ethical environment of Clinical Studies
Excellent organizational and management skills
Scientific rigor, ability to analyze, interpret, write and report
Good verbal and written communication skills
Good computer literacy

Qualifications

Bachelor’s degree in the life sciences, advanced degree preferred
Minimum 1 year experience of medical writing, either within pharmaceutical industry or medical communications
Ability to interpret and organize complex scientific/medical content into concise messages
Project management skills and ability to successfully manage assignments on time with high quality
Advanced computer skills, including knowledge of MS Word, PowerPoint and Excel; reference databases
Ability to communicate clearly and work collaboratively across multiple departments
Ability to multi-task and work within shortened timeframes

At DBV Technologies, we celebrate full expression of our four core values and their associated professional behaviors. Also known as the 4Cs, these values - Curiosity, Courage, Collaboration and Credibility - are rooted in the DNA of our company.

With roots in France, and a strong American and Australian presence, our ambition is global. Do you want to join an ambitious biotech company where employees are passionate about science and innovation! DBV Technologies is committed to studying all applications with the utmost care and without discrimination.

Join us at DBV Technologies!

DBV Technologies

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Medical Writer