Sanofi Hiring Expert Medical Regulatory Writers

Sanofi Hiring Expert Medical Regulatory Writers

11 March, 2022

About the job

Mission statements

  • 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 peer 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.

Qualifications

  • Advanced degree in life sciences/ pharmacy/ similar discipline (Phd, Masters, or Bachelors in science, D Pharms) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
  • Excellent English language knowledge (Spoken and Written)

Requirements of the job

  • ≥8 years of experience in regulatory writing for the pharmaceuticals / healthcare industry
  • Expert knowledge of and demonstrated accomplishment in global registration of drugs
  • Excellent communication skills (written, verbal and presentation)
  • Substantial knowledge of biostatistics principles
  • Experience of managing global, cross-functional teams and working in Matrix environment
  • Demonstrated ability to motivate, coach or mentor people.

Apply through below link

https://www.linkedin.com/jobs/view/2958731674/?refId=UUjOcw8HSN%2FtPdfAqyRxrQ%3D%3D&trackingId=UUjOcw8HSN%2FtPdfAqyRxrQ%3D%3D&midToken=AQHmsj73qo3RDQ&midSig=3E0fJpvW6LRG81&trk=eml-email_jobs_viewed_job_reminder_01-similar_jobs-56-similar%7Ejob%7Etitle%7Emercado&trkEmail=eml-email_jobs_viewed_job_reminder_01-similar_jobs-56-similar%7Ejob%7Etitle%7Emercado-null-fkrvld%7El0ldtv8h%7Esm-null-jobs%7Eview

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