Sanofi is hiring experienced Medical Regulatory Writers to join its Hyderabad team in a permanent, full-time role. This exciting opportunity offers a chance to work with Sanofi’s global business units across specialty care, vaccines, and R&D, supporting medical and regulatory writing needs. If you have over two years of pharmaceutical writing experience and a passion for scientific communication, this role could be your next big career move.
Job Title: Medical Regulatory Writer
Grade: NA
Hiring Manager: Head Scientific Communications/Team Lead
Location: Hyderabad
% of Travel Expected: Travel required as per business need
Job Type: Permanent and Full Time
About the Job
Our Team:
Sanofi Business Operations is an internal Sanofi resource organization based in India. It is set up to centralize processes and activities supporting specialty care, vaccines, general medicine, 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
Under guidance, write and/or edit high-quality safety documents, medical sections of periodic benefit-risk evaluation reports, addendums to clinical overviews, disease and product ID cards, product alerts, and trial transparency documents. Ensure delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines.
Essential Job Duties and Responsibilities
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Participate in the planning of analysis and data presentation with support from a mentoring medical writer.
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Develop and maintain TA expertise.
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Collaborate effectively with global or local Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, Regulatory, and Corporate Affairs teams for assigned documents.
People
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Maintain effective relationships with end stakeholders (medical scientific community) within the allocated global business unit and product to develop medical regulatory content as required.
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Interact effectively with medical and pharmacovigilance department stakeholders.
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Assist other medical regulatory writers in developing knowledge and sharing expertise.
Performance
Provide deliverables (PBRER, ACO, ID Cards, Product Alerts, trial postings, study protocols, amendments, results, redacted documents, lay summaries) per agreed timelines and quality on websites like CTG, EUCTR, and EUDRACT.
Process
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Author, review, and act as an expert in medical regulatory writing, maintaining country-specific regulatory requirements.
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Assist the medical team in the medical regulatory writing needs analysis.
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Implement elements of the medical regulatory plan and associated regional activities.
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Work with vendors to deliver the required outputs as per the process.
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Improve content and delivery based on customer feedback.
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Prepare/review SBS QA documents for Product Alerts.
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Track, file, or archive documents in relevant systems, ensuring audit readiness.
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Stay updated on Sanofi Policy or the evolution of quality documents.
Stakeholders
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Work closely with regional Clinical/Medical teams to identify writing needs and develop deliverables.
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Liaise proactively with Clinical, Medical, Pharmacovigilance, Biostats, Legal, Regulatory, and Corporate Affairs teams.
About You
- Experience: Minimum 2 years in pharmaceutical/healthcare regulatory writing.
- Soft Skills: Stakeholder and vendor management, communication skills, ability to work independently and in teams.
- Technical Skills: Medical writing/editing, data retrieval, scientific interpretation, literature screening, ICH/GCP/GVP knowledge, scientific summarization, document editing, and proficiency with digital tools.
- Education: Advanced degree in Clinical, PhD, Master’s, Bachelor’s in Science, D Pharma, PharmD
- Languages: Excellent English reading, writing, and speaking skills.
Keywords: Medical Regulatory Writer, Sanofi, Healthcare, Pharmaceutical, Regulatory Writing, Stakeholder Management
