R&D Senior eDS Specialist

Job title: R&D Senior eDS Specialist 

• Location: Hyderabad

Our Team:

The electronic Document Specialist (eDS) role operates within the Clinical Electronic Document Management (CEDM) subgroup of CSO-Clinical Documentation. The primary functions of the eDS role are as follows:

To ensure format and submission-readiness validation of clinical documents prepared in the official Sanofi electronic Document Management System (eDMS). Perform compilation/publishing of non-complex documents and implement navigation required to submit clinical Electronic Documents and Dossiers to Health Authorities.

The eDS works in close collaboration with Sanofi teams responsible for the operational delivery of clinical documents. This role works with internal members of Clinical Documentation, such as medical writers and record managers, as well as contributors from other functional areas, including (but not limited to) Regulatory, Pharmacology, Statistics, Clinical Leaders, and Project Leaders.

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

Main responsibilities:

• Perform format and submission-readiness validation of clinical documents. Ensure that all Sanofi requirements are applied as per SOP and guidance.

• Publish/compile clinical documents that consist of multiple components.

• Create clinical documents in the Sanofi eDMS. ensure conformity of clinical documents (e.g., naming conventions, metadata within the eDMS).

• Set links within documents (internal).

• Publish/compile non-complex clinical documents as required.

• Support projects for publish of Clinical Study Reports:

• Review and confirm feasibility of publishing/compilation Microplans (timelines) provided by Sanofi Medical Writers

• Monitor the availability of appendices.  Follow-up with contributors.

• Perform format and submission-readiness validation on appendices.

• Compile all documents in the required/correct order.

• Perform format and submission-readiness validation on the publishing/compilation.

• Electronically approve, within the eDMS, all clinical documents. 

• Computer Technology: Function as an expert user by building experience with required software and systems. Propose technical solutions based on previous experience and expertise gained within the eDS role.

• Leadership: Lead a project by collaborating orally and in writing with English-speaking colleagues in all regions, as needed.

• Organization and Prioritization: Organize and prioritize workload/multiple requests to comply with agreed-upon timelines and ensure that Sanofi business needs are met.

• Process improvement: Identify opportunities to streamline ways of working.

• User Testing: Perform user testing of new tools and applications, as needed.

• Training/Pedagogy: Function as a Subject Matter Expert (SME) to train eDS colleagues, as well as users/customers according to their needs.

About you

• Pharmaceutical industry experience or related industry experience is preferred. Document management experience is an advantage.

• ⁠Experience of formatting electronic documents and or submission dossier experience is desirable. Knowledge or experience with Artificial Intelligence (AI).

• Excellent verbal, written, organizational and interpersonal skills with an assertive and diplomatic approach, not afraid to ask for help as and when required.

• Highly self-motivated, pro-active, open minded, responsible, and autonomous individual. With a strong attention to detail and the ability to handle multiple tasks simultaneously.

• Collaborative team player with orientation towards building and maintaining effective relationships with strong culture awareness.

• Ability to work under pressure, adaptability to change, solve problems and willingness to learn to drive to meet short deadlines and shifting priorities.

• Ability to work with multifunctional and multicultural teams in a matrix organization.

• Strong appetite for digital and tech savvy individual.

• Strong computer software skills and solid knowledge of MS Office 365 environment including advanced competency in MS Word (ability to format and work with features).

• Specific software tools desired, not mandatory: eDMS such as Vault RIM, publishing tools, Acrobat (ISI Toolbox).

• Bachelor’s degree in life science or related is preferred. Strong Command of English in both verbally and in writing.

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, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!