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Job title: EDS Team Lead
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 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 organization's 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 (e.g. 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 (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.
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 : Bachelor’s degree 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 R&D community
Pursue Progress . 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 video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Pursue progress , discover extraordinary
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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)