Associate Medical Writer
About The Position
DBV Technologies is seeking a detail-oriented Associate Medical Writer/QC Specialist to support the development of clinical trial documents and regulatory submissions. The role focuses on scientific writing and meticulous document compilation, including clinical study reports, protocols, Investigator’s Brochures, DSURs, and related documents. The successful candidate will optimize SharePoint document organization, work efficiently under shortened deadlines, and communicate proactively with stakeholders to ensure established timelines are met. Additional responsibilities may be assigned based on project needs and organizational priorities. The position is based in Warren, New Jersey, with a minimum of three days onsite.
Requirements
- Bachelor’s degree in life sciences, scientific communications, or a related field.
- Minimum of 2 years of medical writing and QC experience.
- Strong attention to detail with proven QC experience.
- Strong multitasking skills and a demonstrated ability to meet tight deadlines.
- Proficiency in the Microsoft Office suite, reference databases, and SharePoint.
- Proficiency 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, including FDA and EMA requirements.
Nice To Haves
- Advanced degree.
- GCP or AMWA certification.
- Ability to interpret and organize complex scientific content into concise messages.
Responsibilities
- Support the 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 data consistency.
- Develop and maintain document components such as lists of abbreviations, references, and appendices, and ensure consistent formatting and style throughout documents.
- Format documents, including tables, figures, and cross-reference insertions.
- Incorporate reviewer feedback effectively and lead comment adjudication meetings.
- Summarize statistical outputs into clear, regulatory-compliant narrative text.
- Adhere to document timelines and provide status updates to management as requested.
- Optimize SharePoint document organization.
- Communicate proactively with stakeholders to support adherence to established timelines.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
