R&D EDS Team Lead

Electronic Document Specialist (EDS) Team Lead

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

Main responsibilities:

• Team Leadership:

  Lead, guide and mentor a team of Electronic Document Specialists, providing guidance, training, and support to achieve their goals and the organizations objectives. Ensure necessary resources and support to complete their tasks efficiently and deliver high-quality work.

• People Management:

  Setting performance standards, conducting evaluations, and providing feedback to help employees improve, professional development and grow.

• Document Preparation:

  Oversee the preparation, compilation, and formatting of electronic documents in accordance with regulatory requirements and company standards.

• Regulatory and Compliance Monitoring:

  Stay abreast of relevant regulations, guidelines, and industry best practices related to submission-related activities on various types of formats (eg eCTD), ensuring all documents adhere to regulatory standards.

• Quality Assurance/Control:

  Implement quality control (eg. QC checklist, guidance etc )as per Sanofi standards and measure to review documents for accuracy, completeness, and consistency, conducting audits as necessary to maintain compliance.

• Process Optimization:

  Identify opportunities to optimize document preparation processes, utilizing automation tools and technology to improve efficiency and productivity.

• Communication and Collaboration:

  Liaise with cross-functional teams, including regulatory affairs, nonclinical (including Research), clinical development, and quality assurance, to gather required documentation and ensure alignment on submission-readiness timelines and objectives.

• Document Management:

  In case of new company acquisitions, support document migration to Sanofi electronic document management system.

• Publishing Support:

  Document compilation and report publishing, ensuring compliance with regulatory requirements and company standards

• Project Management:

  Coordinate multiple submission-related activities simultaneously, prioritizing tasks and allocating resources effectively to meet project milestones and regulatory deadlines.

• Continuous Improvement:

  Drive continuous improvement initiatives within the team, implementing feedback mechanisms and performance metrics to monitor progress and identify areas for enhancement.

About you

• Experience leading transversal teams and managing electronic documents within the pharmaceutical industry, with a focus on regulatory submissions for clinical trials and registrations (eg CTDs)
• .Strong understanding of regulatory requirements and guidelines governing pharmaceutical submissions (eg, FDA, EMA).
• 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.
• Proven ability to use excellent verbal and written communication skills to effectively collaborate with multiple levels in the organization.
• Ability to manage simultaneous priorities and lead complex projects and timelines in a matrix team environment.
• Demonstrate excellent attention to detail and accuracy; apply project management skills to appropriate activities.
• In-depth understanding of the drug development process and comprehensive knowledge of global regulatory regulations and guidelines.
• Demonstrated and recognized capacity to identify critical submission-related activities or publishing issues, determine the causes, and propose creative, achievable, and efficient solutions.
• Demonstrated leadership abilities with strong negotiating/influencing skills and effective people management.

• 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