Job Description

Job summary

• To ensure the format and submission-readiness validation of all documents that need to be prepared in the official Sanofi electronic Document Management System (eDMS) such as clinical documents, CTD, PSMF, etc.
• Perform compilation/publishing of documents and implement navigation required to submit dossiers to Health Authorities.
• The eDS works in close collaboration with Sanofi teams responsible for the operational delivery of the documents
  

Essential Job duties and responsibilities

• 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.
• Organization and Prioritization: Organize and prioritize workload/multiple requests to comply with agreed-upon timelines and ensure that Sanofi’s 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.
• Actively leads and develops MedHub operations activities
• Ensure new technologies are leveraged
• Follow-up with the Medical Writers and other contributors for performing submission readiness
• Provide 1-1 support to authors/contributors and eDMS Users
• Participate in the review of eDMS-related guides, as appropriate
• Coordinate work that is subcontracted to vendors/CROs, providing technical support to vendors, seeking/identifying solutions, facilitating interaction and exchange of information, overseeing/managing vendor activities
• Collaborates effectively 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
• If require, eDS may act as an alliance with the project specialist to learn and develop the end-to-end process through Datavision, Matrix, approval/compliance tools (e.g., PromoMats, NAYA), or any contracting database

Performance Standards: Duties & Responsibilities People (Weightage 15%)

• Maintain effective relationships with the end stakeholders (Medical scientific community) with an end objective to develop education and communication content as per the requirement
• Interact effectively with stakeholders in medical and pharmacovigilance departments
• Constantly assist medical regulatory writers in submission readiness activities, as required
• Performance indicators Feedback from stakeholders (end users, medical team) on overall satisfaction

Performance (Weightage 40%)

• Ensure electronic documentation/publication materials are delivered, stored as per agreed timelines and quality
• Perform format and submission-readiness validation of clinical documents. Publish/compile clinical documents that consist of multiple components.
• Create clinical documents and “binders” (as applicable) in the Sanofi eDMS. Ensure conformity of clinical documents (e.g., naming conventions, metadata within the eDMS).
• Set links within documents (internal) and publish/compile clinical documents (including CSR, CO, and Clinical Summaries) as required, including review and confirmation of the feasibility of publishing/compilation of Micro plans (timelines), monitoring the availability of appendices, performing format and submission-readiness validation on appendices, compiling all documents in the required/correct order and performing format and submission-readiness validation on the publishing/compilation.
• Electronically approve, within the eDMS, all clinical documents

Performance indicators

• Adherence to timeline
• Adherence to quality target
• Adherence to budget

Process (Weightage 30%)

• Support the delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards for deliveries made by the medical writing group, including scientific documents and clinical/medical reports in the document management system/ approval-compliance
• Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the medical writing group
• Secure adherence to compliance procedures and internal/operational risk controls in accordance with all applicable regulatory standards
• Support Sanofi Regulatory in the contribution of submission-ready clinical documents for applications in electronic Common Technical Document (eCTD) format.
• Support Medical Writers in the completion of the electronic Table of Contents (eTOC) dossier-planning spreadsheet.
• Perform transversal activities, including identifying the need for eDMS user training, communicating the user needs, performing specific types of training, and participating in the development of new tools.

Performance indicators

• Feedback from stakeholders (end users, medical team) on overall satisfaction
• Observations in case of audit/inspection

Stakeholders (Weightage 15%)

• Liaise with the Medical department to prepare relevant & customized deliverables

Performance indicators

• Feedback from stakeholders (end customers, medical teams) on satisfaction with services provided

Knowledge, Skills & Competencies / Language

• Computer Technology: Function as an expert user by building experience with required software and systems.
• Knowledge of clinical document lifecycle, electronic Document Management System (eDMS), and publishing tools.
• Understand regulatory requirements related to document structure and navigation.
• Communicate effectively in English (written and verbal).

Qualifications

• 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

Any other 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).

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.