Sanofi Group Labeling Excellence & Operations Manager, Swiftwater, PA in Swiftwater, Pennsylvania

Job Summary :

Within Global Labeling, this position is part of the Global Labeling Excellence & Operations’ team. To ensure timely dispatch of global labeling update and related supporting documentation to Sanofi worldwide affiliates and relevant Business partners. To work with Global Labelling Strategists in order to ensure compliance of the labelling documents to regulations and company standards. To coordinate regional and local processes for timely and accurate implementation of labeling change.

Job & responsibilities:

Support includes:

Timely dispatch of global labeling update and related supporting documentation

  • following the decision of the Labelling Review Committee, plans the dispatch of corporate packages and communicates timelines to stakeholders

  • initiates dispatch preparation by completing and sending request forms for corporate package publishing to the GRA Publishing team to initiate the dispatch

  • interacts with authoring functions to ensure availability of approved supporting documentation in repository system and completion of table of content, as per defined timelines.

  • prepares the notification letter for countries with instructions for implementation of the global labelling change.

  • updates internal databases in order to be able to track end-to-end implementation of global labelling changes

  • QC global labelling documents authored by the Global Labeling Strategists

  • sends updated global labelling documents and related supporting documents to Business partners Participation to the preparation of labelling elements for submission to Health Authorities

  • performs QC on local product information (i.e. USPI, EU SmPC…) before submissions to Health Authorities.

  • manages eCTD EU activities for modules involving EU translations, mockups and readability testing (i.e. submissions, closing sequence…)

  • interacts with EU RA affiliates, the EMA and national agencies as « Translation contact point » for EU procedures requiring a linguistic review (variations for Centrally Approved products, or national PSUSA)

  • acts a regulatory referent for packaging in EU CP and US products

  • provides instructions for industrial implementation to EU affiliates following approval of EU CP variations affecting the product information and coordinates response in case of questions

  • uploads approved US and EU CP approved product information in central repository system

  • coordinates leaflet readability testing for EU CP, EU MRP & EU DCP with internal project team and external vendor

  • ensures timely availability of SPL with vendor for US PI

  • initiates process for US artwork update and validates the revised artwork Other activities

  • represents Global labeling operations in assigned working groups

  • participates to update of Quality documents related to Labeling Operations activities.

  • Performs other regulatory labelling duties as required (e.g., document preparation for regulatory inspections).

  • US specifics: preparation of SPLs, SPL review of metadata with decision making and submission to FDA whenever needed.

  • EU specifics: preparation of Labeling part of the documents for EMA submission for its portfolio.

Knowledge and Skills:

• Experience of Labeling Processes, Corporate or Affiliate

• Organizational Skills: capacity to work in networks and to coordinate discussions to reach objectives.

• Must be active and demonstrate initiative; capability of carrying out multiple tasks.

• Excellent communication skills

• Technical Skills: Microsoft Office, IS tools for correction of documents, quality control of documents, as well as, knowledge of data bases. Capacity to learn new tools.

• Capacity of fast adaptation and flexibility.

• Fluent English (verbal and written)

Education and experience:

  • Minimum of 3 years in Regulatory Affairs, or Pharmacovigilance, and of 5 years in Pharmaceutical Industry.

  • This position is within Corporate experience working in an international environment would be a plus.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA

#LI-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