Sanofi
Senior Medical Regulatory Writer
Sanofi, Baltimore, Maryland, United States,
Senior Medical Regulatory Writer
Locations:
Hyderabad
Time Type:
Full time
Posted On:
Posted 9 Days Ago
Job Requisition ID:
R2762118
About the Job:
Our Team:
Sanofi Business Operations is an internal Sanofi resource organization based in India and is set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
Main Responsibilities:
Write and/or edit high-quality safety and clinical documents, including medical sections of Periodic Benefit-Risk Evaluation Reports, Clinical Study Reports (CSR), and clinical evaluation reports.
Deliver high-quality medical documents on time and in compliance with internal and external standards and guidelines.
Work independently on documents with minimal supervision and act as a mentor to other medical writers.
Participate independently in the planning of analysis and data presentation.
Develop and maintain therapeutic area expertise.
Review content created by peers.
Collaborate with global or local teams in Scientific communication, Medical regulatory writing, Pharmacovigilance, and Regulatory Affairs.
Maintain effective relationships with stakeholders in the medical scientific community.
Provide deliverables (PBRER, ACO, CSR, etc.) as per agreed timelines and quality.
Assist in conducting comprehensive medical regulatory writing needs analysis.
Work with selected vendors within the region to deliver required documents.
Ensure audit and inspection readiness by tracking postings and archiving materials.
Remain updated on Sanofi Policy or Quality Documents evolution.
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:
Medical operational excellence, time and risk management, excellent technical editing and writing skills, data retrieval, interpretation of scientific data, knowledge of ICH and GCP/GVP.
Education:
Advanced degree in life sciences, pharmacy, or 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).
Pursue progress, discover extraordinary.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
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Locations:
Hyderabad
Time Type:
Full time
Posted On:
Posted 9 Days Ago
Job Requisition ID:
R2762118
About the Job:
Our Team:
Sanofi Business Operations is an internal Sanofi resource organization based in India and is set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
Main Responsibilities:
Write and/or edit high-quality safety and clinical documents, including medical sections of Periodic Benefit-Risk Evaluation Reports, Clinical Study Reports (CSR), and clinical evaluation reports.
Deliver high-quality medical documents on time and in compliance with internal and external standards and guidelines.
Work independently on documents with minimal supervision and act as a mentor to other medical writers.
Participate independently in the planning of analysis and data presentation.
Develop and maintain therapeutic area expertise.
Review content created by peers.
Collaborate with global or local teams in Scientific communication, Medical regulatory writing, Pharmacovigilance, and Regulatory Affairs.
Maintain effective relationships with stakeholders in the medical scientific community.
Provide deliverables (PBRER, ACO, CSR, etc.) as per agreed timelines and quality.
Assist in conducting comprehensive medical regulatory writing needs analysis.
Work with selected vendors within the region to deliver required documents.
Ensure audit and inspection readiness by tracking postings and archiving materials.
Remain updated on Sanofi Policy or Quality Documents evolution.
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:
Medical operational excellence, time and risk management, excellent technical editing and writing skills, data retrieval, interpretation of scientific data, knowledge of ICH and GCP/GVP.
Education:
Advanced degree in life sciences, pharmacy, or 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).
Pursue progress, discover extraordinary.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
#J-18808-Ljbffr