R&D Electronic Document Specialist

Electronic Document Specialist

The eDS works in an environment in constant evolution and needs to be prepared to work with new technologies including Artificial Intelligence.

Main responsibilities:

• Document Preparation

  : Create and format documents, dossiers (including binders of authoring documents), reports, and perform submission-readiness validation according to regulatory guidelines and requirements for inclusion or not into the submission related activities (eg eCTD). This includes ensuring consistency in formatting, adherence to document templates, and compliance with Sanofi standards.

• E-Submission-ready Compliance:

  Ensure that all documents meet the specifications outlined for electronic submissions (eg INDs, CTDs), including file formats, naming conventions, and metadata requirements.

• Quality Assurance/Control:

  Conduct formatting quality checks on documents to ensure accuracy, completeness, and compliance with regulatory Sanofi standards, including reviewing documents (eg linking errors, inconsistencies) and making necessary revisions.

• Communication and Collaboration:

  Collaborate with cross-functional teams, including regulatory affairs, nonclinical (including Research), clinical development, quality assurance, CMC, ITS and other stakeholders, to gather the necessary information and documents for ensuring submission-readiness of the documents.

• Document Management:

  Manage electronic documents throughout the document preparation process, including version control (eg locked documents, embargo), tracking changes, and ensuring document integrity and security by using document management systems or other electronic tools to organize and maintain documents.

• Documentation:

  Maintain accurate and detailed records of document preparation activities, including documentation of any changes, revisions, or approvals made to documents during the submission-related activities.

Publishing Support:

About you

• Experience

  : Experience in electronic documentation preparation, with a focus on regulatory submissions for clinical trials and registrations (eg CTDs)
• Understanding of regulatory information management Vault RIM systems, mastery of document management software and tools, such as electronic document management systems (EDMS), Adobe Acrobat, Microsoft Office Suite, and other relevant software used for document preparation and submission. Understandingof eCTD structure and specifications, including knowledge of XML tagging, metadata requirements, and file formats for electronic submissions.
• Ability to troubleshoot technical issues related to document formatting, conversion, and document preparation processes.Strong attention to detail is essential for ensuring accuracy and completeness in document preparation and compliance with regulatory requirements.
• Ability to meticulously review documents for errors, ensure consistency, and compliance with formatting guidelines and naming conventions. Skillin maintaining version control and tracking changes to documents throughout the document preparation process to ensure document integrity. Familiaritywith regulatory guidelines, standards, and requirements relevant to electronic document management and submissions in the pharmaceutical industry.
• Understanding of regulatory processes and documentation requirements for different stages of drug development, including INDs, NDAs/BLAs, and other regulatory submissions. Awarenessof evolving regulatory trends, updates, and best practices related to electronic submissions and document management.
• Effective communication skills to collaborate with cross-functional teams, including regulatory affairs, nonclinical (including Research), clinical development, quality assurance, ITS, CMC, and other stakeholders involved in document preparation and submission processes.
• Ability to convey technical information clearly and concisely to non-technical stakeholders and provide support and guidance on document management and submission-related queries. Fluency in English, both written and spoken Skillin building positive working relationships and facilitating teamwork to achieve common goals related to regulatory submissions.
• Strong problem-solving skills to troubleshoot issues and find solutions related to document formatting, conversion, and submission challenges. Abilityto adapt to changing regulatory requirements, technology updates, and organizational processes, while maintaining quality and compliance in document management and submission-related activities.

• Education

  : bachelorsdegree or equivalent degree in regulatory affairs, sciences, related areas of study, and/or relevant experience

• Languages

  : Communicate effectively in English (spoken and written

Why choose us

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Play an instrumental part in creating best practices within the RD community.