Sanofi

Medical Expert – Regulatory Writing ,Global Medical Hub (BB-F9CAF)

Found in: Talent IN

Description:
  • Role Expectation
  • 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

    People

  • 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
  • Performance

  • 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
  • Process

  • 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
  • Customer

  • 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
  • Qualification

  • 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.
  • 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.

    calendar_today1 day ago

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    info Full time

    location_on Hyderabad, India

    work Sanofi

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