Expert Medical Regulatory Writer

☞ Sanofi

View: 108

Update day: 06-05-2024

Location: Hyderabad / Secunderabad Telangana

Category: Health / Medical Care

Industry: Pharmaceutical Biotechnology

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Job content

  • Write and/or edit under guidance high quality clinical and safety documents for submission to regulatory authorities to support marketing authorization application, renewals, and maintenance activities including complex Clinical Study Reports (CSR), complex CTD submission documents (clinical overview (CO), summary of clinical efficacy (SCE), clinical safety (SCS), clinical pharmacology (SCP), and biopharmaceutics (SBP)), medical section of Periodic Benefit-Risk Evaluation Report (PBRER), addendum to clinical overview (ACO), Risk Management Plans (RMP) ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, and responses to Health Authorities Queries, immunogenicity reports.
  • Leading complex submissions, contributing to key messaging meetings, providing expert content guidance for medical sections of CTD, and delivery of high-quality medical documents in time and in compliance with internal standards and external guidelines.
  • Participate in planning of analysis and data presentation to be used as an ad-hoc member of the Clinical Trial Team (CTT), core member of the Clinical Submission Teams (CST) and extended member of the Global Clinical teams (GCT) and Safety management team (SMT)
  • Develops and maintains TA expertise and to provide document-related advocacy to other line functions
  • Reviews content created by peers writers and act as a coach, mentor, trainer for development of writers for the new document type
  • Work with minimal supervision and support development of medical regulatory writers
  • Agile and knowledgeable to be able to work across TA.

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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Deadline: 20-06-2024

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