Location: Hyderabad
About the job
Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi R&D department and providing a springboard for the amazing work we do. Build a career with us and you can be part of transforming our business while helping to change millions of lives. Ready? As a Senior Electronic Document Specialist within our Hyderabad Hub, you’ll be responsible for managing documents for regulators, 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 senior 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 (e.g. 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 (e.g. 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 Sanofi standards, including reviewing documents (e.g. 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 (e.g. 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. 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.
Regulatory and Compliance Monitoring: Monitor regulatory updates and changes to ensure ongoing compliance with evolving electronic documentation requirements and standards including staying informed about new guidelines, best practices, and technological advancements in electronic submission processes. Keep abreast of current regulatory intelligence and industrial best practices
Training and Support: Provide training and support to internal teams on submission readiness document preparation guidelines, and best practices to help ensure consistency and efficiency in document preparation across the organization.
Continuous Improvement: Identify opportunities for process improvements and efficiencies in document preparation and submission-readiness processes, including proposing and implementing changes to streamline workflows, enhance quality, or reduce errors.
About you
Experience: Previous experience in electronic document management within the pharmaceutical industry, with a focus on regulatory submissions for clinical trials and registrations (e.g. CTDs)
Strong understanding of regulatory requirements and guidelines governing pharmaceutical submissions (e.g., 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.
Understanding of 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.
Skill in maintaining version control and tracking changes to documents throughout the document preparation process to ensure document integrity.
Familiarity with 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.
Awareness of evolving regulatory trends, updates, and best practices related to electronic submissions and document management.
keep abreast of current regulatory intelligence and industrial best practices
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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
Skill in 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.
Ability to adapt to changing regulatory requirements, technology updates, and organizational processes, while maintaining quality and compliance in document management and submission-related activities.
Education: Bachelor’s degree or equivalent degree in regulatory affairs, IT, sciences, related areas of study, and/or relevant experience
Languages: Communicate effectively in English (spoken and written
Dona Wolfington, Clinical Documentation Global Head
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 R&D community.
PursueProgress. Discover Extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN videoand check out our Diversity Equity and Inclusion actions at sanofi.com!
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!