Sanofi Group Quality Documents and Training Coordinator in Bridgewater, New Jersey

The associate participates in the development; implementation and maintenance of a quality system related to the quality documents and related training:

  • Support Global Pharmacovigilance quality documentation and its related training

  • Promote harmonization of quality standards

  • Communicate on processes and tools related to QD & training activities

Main missions of the role are described below:

  • Participate in the definition of GPV standards, to ensure the preparation and maintenance of Quality documents (QDs) applicable for GPV in line with global quality directives and to ensure the delivery of training of the respective QDs

  • Promote a single consistent approach in sanofi processes:

  • Contribute to the establishment and monitoring of the annual QD plan. Ensure sanofi architecture of QD is applied.

  • Foster simplification and avoid redundancy of Quality Documents

  • Ensure timeliness and quality of PV 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 PV Quality Documents

  • Ensure required or essential quality documents are authored in due time in collaboration with respective Subject Matter Experts (SMEs).

  • Collaborate with the Quality Document network with associates from other functions

  • Coordinate or participate to specific projects related to PV or quality process or tools improvements

  • Contribute to the preparation of Quality Documents metrics and Key Performance Indicators

Requirements:

  • Certified health professional degree preferred: example Pharmacist or Pharm D or Bachelor of nursing degree or Health Science degree required

  • Minimum experience 5 to 7 years in International Pharmacovigilance activities, involvement in interaction with affiliates, training users and vendor management

  • Experience in GxP Quality system management notably in Quality Documents writing

  • Experience in Medical writing

  • Knowledge of international regulations and guidelines ICH, CIOMS, EMA and FDA Pharmacovigilance regulation.

#GD-SA

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life