M&S Services, PV & Medical - Quality Documents & Training Manager

About the job

Our Team:

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life.

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs.

Main responsibilities:

• Ensure the preparation and maintenance of Pharmacovigilance and Medical Quality documents (QD’s) 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 Electronic Document Management System:
• Ensure documents are following the correct workflow steps
  • Perform a QC step of each document
  • 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
• Participate in company acquisition and divestments projects on QD strategy and implementation plan. As well as, perform gap assessments on Global QDs and follow-up CAPA plan. Provide guidance and support to countries on the management of their local QDs
• Contribute to the preparation and communication of Quality Documents metrics. Support inspections and audits by providing required data on due time, participating to interviews, contributing to root cause analysis and CAPA proposal

About you

Experience:

• Experience in GxP Quality system management minimum 2 years
• Experience in Quality Documents or Medical writing minimum 2 years
• Experience in Pharmacovigilance and/or Medical activities minimum 2 years. Knowledge in International Pharmaceutical Regulation e.g. GVP, GCP, ICH
• 5-7 years of Experience in relevant industry

Technical skills:

• Pharmacovigilance
• Quality systems
• Medical Writing
• Electronic Data Management System (EDMS)
• Quality Risk Management
• Project management skills
• Use and develop Dashboards

Soft skills:

• Act for change                                                                                                           
• Advanced commit to customers
• Cooperate transversally                                                                             
• Strive for results                                                                                         
• Internal and external networking capability                                                
• Problem solving                                                                                          

Education:

• Certified health professional degree: example Pharmacist, Health Science degree, Bachelor of nursing degree

Languages:

• good level of Professional English

Why choose us?

Contribute to the deployment execution & successful delivery of the solutions at manufacturing site in alignment with the defined strategy and process designed (adherence to prescribed Global process, local UAT testing, training execution, user adoption & support).

PursueProgress. 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

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