Sanofi – Senior Medical Regulatory Writer (Advanced Life Sciences Degree) – Apply Now
Are you a highly skilled and experienced regulatory writer with an advanced degree in life sciences or a related discipline, and a minimum of 5 years of experience in the pharmaceutical/healthcare industry? Sanofi, a global healthcare leader, is seeking a talented Senior Medical Regulatory Writer to join our team in Hyderabad. If you possess excellent writing and editing skills, a strong understanding of regulatory guidelines, and the ability to collaborate effectively with cross-functional teams, we encourage you to apply! This is a permanent and full-time position.
Job Title: Senior Medical Regulatory Writer
Job Details:
- Hiring Manager: Head Scientific Communications/ Team lead
- Location: Hyderabad
- % of Travel Expected: Travel required as per business need
- Job Type: Permanent and Full time
- Job Requisition ID: R2789778
Main Responsibilities:
As a Senior Medical Regulatory Writer at Sanofi, you will be responsible for:
- Writing and/or editing high-quality safety and clinical documents, including medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts, and trial transparency documents, demonstrating advanced knowledge and expertise.
Essential Job Duties and Responsibilities:
- Participating independently in the planning of analysis and data presentation to be used in regulatory documents.
- Developing and maintaining therapeutic area expertise.
- Reviewing content created by peer writers.
- Collaborating effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams, and Corporate Affairs Teams based on the documents assigned.
About You:
- Experience: >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
- Soft Skills: Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment
- Technical Skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications)
- Education: Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
- Languages: Excellent knowledge of the English language (to read, write, and speak
Keywords: Senior Medical Regulatory Writer, Sanofi, Hyderabad, Full time job, Medical Regulatory Writer job, Regulatory writing, Pharmaceutical industry, Healthcare industry, Medical documents
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