R&D EDS Team Lead

As a  Electronic Document Specialist (EDS) Team Lead  within our Hyderabad Hub, you'll be responsible for managing documents and team resources, while upholding Sanofi s long history of producing high-quality submissions. It s a chance for you to make an impact across the entire portfolio and ensure patients are receiving the care and medications they need to live healthy lives .

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

Why choose us

Skills Required

Document Management, Continuous Improvement, Process Optimization, Edms, Adobe Acrobat, Publishing, Clinical Trials, Information Management