- 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.
- Alliance with the project specialist to learn and develop on end-to-end process through Datavision, Matrix, approval/compliance tools (e.g., PromoMats, NAYA) or any contracting database.
Knowledge, Skills & Competencies / Language
- 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.
- Strong and thorough knowledge of MS WORD functionality and advanced skills in using Adobe Acrobat.
- Collaboration: Manage document-related activities globally, with teams and colleagues, as appropriate, in all countries/regions.
- Organization and Prioritization: Organize and prioritize workload/multiple requests to comply with agreed-upon timelines and ensure that Sanofi business needs are met.
- Negotiation: Understand valid criteria for challenging various demands of users/customers. Be able to understand and identify priorities for the purpose of negotiating timelines.
- Knowledge of clinical document lifecycle, electronic Document Management System (eDMS) and publishing tools.
- Regulations: Understand regulatory requirements related to document structure and navigation.
- Communication: Communicate effectively in English (written and verbal).
- Graduate / Post Graduate degree in life science preferred
- Knowledge of Clinical development, submission dossiers and Sanofi procedures preferred
- Awareness of Specific software tools such as eDMS, publishing tools, Acrobat (ISI Toolbox) and MS Office 365 environment are an added advantage
Requirements of the job
- 1-3 years of experience in the pharmaceuticals industry is preferred (electronic Documentation Specialist/ Project Management experience)
- Industry experience should be within comparable sectors or roles (computer systems, electronic document management systems/ project specialist role).
Apply : https://sanofi.wd3.myworkdayjobs.com/en-US/SanofiCareers/job/Hyderabad/Project-Specialist—eDS_R2612230?utm_source=Linkedin.com&utm_campaign=annual_all_business&utm_medium=social_media&utm_content=job_posting&ss=paid&source=Linkedin&dclid=CjgKEAjwsZKJBhDc3ZmoiqDdpEoSJADvcjtf9mNpxIrq3V4A9NAyF4uy-DDhA4rkodMvOK0tzu7UBfD_BwE