Life Science Medical Regulatory Writer Job at Sanofi – Apply Online
Medical Regulatory Writer
Location: Hyderabad, India
Type: Permanent
Posted On: Dec. 12, 2024
Closing Date: Mar. 03, 2025
About the Job
Our Team:
Sanofi Business Operations is an internal Sanofi resource organization based in India, established to centralize processes and activities supporting Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data, and Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations globally.
Main Responsibilities:
- Write and/or edit under guidance high-quality safety documents, medical sections of the Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to Clinical Overview, Disease and Product ID Cards, product alerts, and trial transparency documents.
- Deliver high-quality medical documents on time and in compliance with internal and external standards and guidelines.
Essential Job Duties and Responsibilities:
- Participate with support in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.
- Develop and maintain Therapeutic Area (TA) expertise.
- Collaborate 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.
People:
- Maintain effective relationships with the end stakeholders (medical scientific community) within the allocated Global Business Unit and product – with the objective of developing medical regulatory content as per requirements.
- Interact effectively with stakeholders in medical and pharmacovigilance departments.
- Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.
Performance:
- Provide deliverables such as PBRER, ACO, Product and Disease ID Cards, Product Alerts management, posting of trial information (study protocols, amendments, study results, redacted documents, lay summaries) on websites like CTG (ct.gov), EUCTR, EUDRACT as per agreed timelines and quality.
Process:
- Author, review, and act as an expert in medical regulatory writing and maintain regulatory requirements for supported countries.
- Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.
- Implement relevant elements of the medical regulatory plan and associated activities for the region.
- Work with selected vendors within the region to deliver required outputs as per the defined process.
- Design an overall plan of action based on end-customer feedback and improve course content and delivery.
- Prepare/review stand-by statements and questions and answer (SBS QA) documents as part of managing Product Alerts.
- Track postings, file or archive material in relevant systems, and ensure audit and inspection-readiness.
- Stay updated on Sanofi Policy or Quality Documents evolution.
Stakeholders:
- Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables.
- Proactively liaise with Clinical/Medical/Pharmacovigilance/Biostats/Legal/Regulatory/Corporate Affairs departments to prepare relevant and customized deliverables.
About You:
Experience: 2 years of experience in regulatory writing for the pharmaceuticals/healthcare industry.
Soft Skills: Stakeholder management, vendor management, communication skills, and the ability to work independently and within a team environment.
Technical Skills:
- 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.
- Proficiency in computer applications.
Education: Advanced degree in life sciences/pharmacy/similar discipline (PhD, Master’s or Bachelor’s in Science, D Pharma, PharmD) or a medical degree (MBBS, BDS, BAMS, BHMS, MD).
Languages: Excellent English language proficiency (reading, writing, and speaking).
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