Project manager – MRW/eDS Job Vacancy in Sanofi Hyderabad, Telangana – Updated today
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Company Name : Sanofi
Location : Hyderabad, Telangana
Position :
Job Description : Write and/or edit independently high quality clinical and safety documents, medical section of Periodic Benefit-Risk Evaluation Report, addendum to clinical overview, Clinical Study Reports (CSR), ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, Medical section of CTA..
Delivery of high-quality medical documents in time and in compliance with internal and external standards
Participate in planning of analysis and data presentation to be used, initially in conjunction with mentoring medical writer.
Develops and maintains TA expertise and act as a strategic thought partner to the TA / BU
Takes lead in liaising with the Global Stakeholders for planning, relationship building, tracking the projects delivered by the team
Reviews, coaches and develops medical writers on content, methods and processes
Accountable for deliverable produced by the reporting team, including accuracy of medical content
Manages a team of medical regulatory writers/electronic documentation specialist (eDS) in delivering high quality medical regulatory documents
Qualifications
Advanced degree in life sciences/ pharmacy/ similar discipline or medical degree (Ph.D/ Master in science)
Excellent English language knowledge (fluent – oral and Written)
Requirements of the job
>8 years of experience in medical regulatory writing for the pharmaceuticals / healthcare industry
1-2 years’ experience as operational or functional manager for formal or informal team will be preferred
Good understanding of work processes for medical regulatory writing
Pro-active and ability to work independently
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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