Associate Medical Writer

DBV Technologies; Bernards Township (NJ); Ibrido; USD 85.000 - 110.000; Tempo pieno

Descrizione del lavoro

DBV Technologies seeks a detail-oriented Associate Medical Writer/QC Specialist to support clinical trial documents and regulatory submissions. You will ensure full QC of SARs, protocols, and DSURs, with meticulous document compilation and SharePoint organization.

The role focuses on scientific writing, with tight deadlines and proactive stakeholder communication to ensure timelines are met. On-site presence in Warren, NJ is required.

Competenze

• Bachelor’s degree in life sciences, scientific communications, or related field.
• Advanced degree preferred.
• GCP or AMWA certification preferred.
• Minimum of 2 years medical writing and QC experience.
• Strong attention to detail with proven QC experience.
• Strong multi-tasking skills and ability to meet tight deadlines.
• Proficient in Microsoft Office, reference databases, and SharePoint.
• Proficient in summarizing data from Tables, Figures, and Listings (TFLs).
• Excellent written communication and drug development understanding.
• Familiarity with ICH-GCP and regulatory submission requirements.

Mansioni

• Support development of regulatory-compliant documents.
• Perform QC reviews of deliverables for editorial and formatting accuracy.
• Develop and maintain abbreviations lists, references, and appendices.
• Format documents including tables, figures, and cross-references.
• Incorporate reviewer feedback and lead adjudication meetings.
• Summarize statistical outputs into regulatory narratives.
• Adhere to timelines and provide status updates to management.

Conoscenze

Medical writing

QC experience

Attention to detail

Time management

Written communication

SharePoint

MS Office

Data summarization

Formazione

Bachelor’s degree in life sciences

Advanced degree

GCP or AMWA certification

Strumenti

SharePoint

Reference databases

Descrizione del lavoro

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.

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.

DBV Technologies is a global clinical stage biopharmaceutical company founded by pediatricians who believed that food allergies could one day be treated safely and effectively.
We are on a mission to advance epicutaneous immunotherapy using our innovative technology platform, Viaskin™, to develop treatment options for immunologic diseases with significant unmet medical need.
This mission drives our commitment to the advancement of treatments for patients and their families. That is why we are investigating a potential new class of immunotherapy, epicutaneous immunotherapy (EPIT), that aims to re-educate the immune system of patients through the skin.
Today, we are focused on exploring the use of Viaskin to address food allergies, a devastating condition that afflicts millions of patients. As an important milestone in our journey, we hope to offer the first epicutaneous immunotherapy treatment for peanut allergy.
Tomorrow, as pioneers, we will continue to explore the broad applications of this potential new class of immunotherapy, including treatments for patients suffering from inflammatory and autoimmune diseases.