SANOFI Hiring Senior Medical Regulatory Writers Advanced degree in life sciences/ Pharmacy/ similar discipline or medical degree (Ph.D – Master in science) Apply Now
Mission statements
Write and/or edit under guidance
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
Reviews content created by peers
writers
Collaboration
Scientific communication global or
local teams
Medical regulatory writing global
or local teams
Pharmacovigilance teams
Duties & Responsibilities
1.People
Maintain effectiveness
relationships with the end stakeholders (Medical scientific community) within
the allocated Global business unit and product – with an end objective to
develop medical regulatory content as per requirement
Interact effectively with stakeholders
on medical and pharmacovigilance departments
Constantly assist other medical
regulatory writers in developing knowledge and sharing expertise
Feedback from stakeholders (end
customers, medical teams) on overall satisfaction
2.Performance
Provide deliverables (PBRER, ACO,
CSR, ID Cards, Investigator brochure, clinical evaluation report, Briefing
packages, Medical section of CTA ) as
per agreed timelines and quality
Adherence to timeline
Adherence to quality target
3.Process
Act as an expert in the field of
medical regulatory writing and maintain on regulatory requirement for countries
supported.
Assist the assigned medical team in
conducting comprehensive medical regulatory writing-needs analysis
Implement relevant element of
medical regulatory plan and associated activities for the year identified for
the region
Work with selected vendors when
required within the region to deliver the required deliverables as per defined
process
Design an overall plan of action basis end-customers feedback & improve course content and delivery
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