Medical Expert – Regulatory Writing ,Global Medical Hub (BB-F9CAF)
Found in: Talent IN
Works with a team of Medical Scientific writers with different level of expertise
Develops medical expertise within Medical regulatory writing (on contents, methods, processes)
Ensures compliance to regulatory requirements for activities supported
Coordinates and supports medical activities related to the maintenance the marketing authorizations of the Established and Generics products, in different therapeutic areas.
Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance and vendors
Responsible to provide medical assessment with relevant and updated clinical evidence and to monitor the execution of strategic documents as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments and labelling documents for the corresponding therapeutic area or products.
Secure delivery of high-quality medical documents in time and in compliance with internal and external standards
Maintain effectiveness relationships with the end stakeholders (Medical, regulatory, pharmacovigilance 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 medical regulatory writing team in developing knowledge and sharing expertise
Secure deliverables (PBRER, ACO, CSR, ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, Medical section of CTA ) are supported as per agreed timelines and quality
Provide medical strategic insights & evaluation for related Sanofi’s portfolio.
Contribute to the management of the marketing authorization dossiers of the current related portfolio.
Act as an expert in the field of medical regulatory writing and maintain regulatory requirement for countries, teams 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
Assist head Medical regulatory writing in designing an overall plan of action basis end-customers feedback & improving course content and delivery
Work closely with Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables
Liaise with Medical department to ensure relevant & customized are delivered per expectation
Medical Degree; MD.
Medical operational excellence, time and risk management skills;
Excellent technical (scientific) editing and writing skills;
Excellent English language knowledge
Requirements of the job
> 5 years’ experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance
Experience in at least one of the Therapeutic area - Cardiovascular, metabolism, Diabetes and Lipid, CNS, Oncology, Anti-infectives, Internal medicine.
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