Sanofi

Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.

Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.

Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for marketed and LCM products

Medical Regulatory Writer at Sanofi. Participate with support in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 

Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related healthcare discipline.

The CTSM Team leader is responsible to support the clinical study leadership to execute and deliver on our clinical studies.

Master or PhD of pharmaceutical. Perform statistical analyses of data from the laboratories using R and possibly other languages SAS or standard statistical software used in Sanofi, JMP, SIMCA, internal tools. Sanofi

Advanced degree in life sciences / pharmacy / similar discipline or medical degree. Stakeholder management; writing/communication skills; external engagement and ability to work independently and within a team environment

Manage core HEVA communication processes, templates, and products across the portfolio in accordance to the scientific and value messages aligned with Core Value Dossier, the US AMCP dossier, and HEVA contributions as appropriate to other submissions