Quality Documents Expert

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* Job Title:

** Quality Documents Expert
** Location**:
Morristown, NJ Cambridge, MA
** About the Job
** Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers.

The Quality Documents Expert is part of the Pharmacovigilance Quality (PVQ) department in PSPV function working in an international and culturally diverse team. The Quality Documents Expert participates to the robustness of the quality system by supporting the Quality Documentation.
** About Sanofi:
** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
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* Main Responsibilities:

*** Supporting the Pharmacovigilance, Medical and Transversal Quality Operations (TQO) quality documentation (QD) and its related training
* Promoting harmonization of quality standards
* Communicating on processes and tools related to quality documentation
** Major duties and responsibilities:
*** Ensure the preparation and maintenance of Pharmacovigilance and Medical Quality documents (QDs) in line with global quality standards
* Promote a single consistent approach in sanofi processes:* + - Contribute to the establishment and monitoring of the annual QD plan. Ensure sanofi architecture of QDs is applied.  + - Foster simplification and avoid redundancy of Quality Documents
* Ensure timeliness and quality of Quality documents in the Content Management System (CMS):* + - Ensure documents are following the correct workflow steps  + - Perform a technical review of each document ensuring writing rules are followed  + - Monitor workflow steps of each document until approval. Remind authors, reviewers and authorizer as needed.  + - Communicate on the approval and effective dates of Quality Documents
* Ensure the delivery of training of the concerned QDs by creating training link in the Learning Management Systems(s) and preparing e-learning material with SMEs
* Lead or participate to specific projects related to process or tools improvements, assess impacts, set up and monitor action plans
* Maintain up-to-date the documentation describing Quality Documents activities
* Perform gap assessments on Global QDs and follow-up Corrective Actions and Preventive Actions (CAPA) plan
* Provide guidances and support to countries on the management of their local QDs
* Contribute to the preparation and communication of Quality Documents metrics and Key Performance Indicators (KPI)
* Support inspections and audits by providing required data on due time, participating to interviews, contributing to Root Cause Analysis (RCA) and CAPA proposal
* Collaborate with key stakeholders from Quality Document network
** About You
**** About You
***
* Qualifications:

*** Bachelor’s degree (Certified health professional degree e.g. Nursing, Pharmacist, Health Science degree)
* 2+ years’ experience in GxP Quality system management, Quality Documents or Medical/Scientific writing
* 2+ years’ experience in Pharmacovigilance and/or medical activities
* Knowledge in International Pharmaceutical Regulation e.g. GVP, GCP, ICH
* Advanced use of Microsoft Word and Excel
* Advanced use of Content Management System (CMS)
* Use and develop dashboards
* Project Management skills
** Preferred:
*** Team player that cooperates transversally in a cross-functional environment
* Analytic, proactive, and problem-solving mindset
* Self–motivated, able to relentlessly prioritize, plan effectively and autonomously
* Organized and detail oriented while seeing the big picture
* Efficient time management
* Customer focus
** Why Choose Us
*** Bring the miracles of science to life alongside a supportive,…