Global Medical Expert
Location: Hyderabad, India
Job Type: Full-Time
Job Summary:
Sanofi is seeking a Global Medical Expert to lead the development, review, and delivery of strategic medical regulatory documents in support of global medical, regulatory, and pharmacovigilance activities. This pivotal role involves cross-functional collaboration to support key products across a wide therapeutic portfolio including diabetes, cardiovascular diseases, immunology, and chronic care.
Key Responsibilities:
Strategic Medical Content Development:
Draft and medically assess regulatory documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk Assessments, MDDs, HAQ responses, labeling documents, and briefing books.
Write key medical/clinical sections of CTDs and oversee execution aligned with SOPs, GCP, and regulatory requirements.
Review and approve compassionate use requests for serious or life-threatening conditions.
Support RWE teams in drafting extended study synopses.
Ensure timely and compliant delivery of high-quality medical documents.
Cross-Functional Collaboration:
Work closely with Global Medical Leads, Regulatory Affairs, Pharmacovigilance, Managed Access Program teams, and writing teams.
Guide vendors and support regional regulatory medical needs.
Engage with global business units to align medical writing strategy with global objectives.
People & Knowledge Development:
Maintain strong relationships with internal stakeholders to deliver tailored medical writing content.
Mentor and support junior writers and team members by sharing therapeutic and regulatory knowledge.
Assist with needs analysis and content planning for medical writing and scientific communications.
Performance & Process Management:
Secure timely delivery of required medical documents across product life cycles.
Contribute to regulatory dossier management and support key activities for marketing authorization.
Monitor feedback, propose content enhancements, and ensure compliance with evolving global regulatory requirements.
Required Qualifications:
Education: MBBS or MD (Medical degree is mandatory)
Experience: Minimum 5 years in medical affairs, clinical development, or pharmacovigilance in a pharmaceutical environment
Therapeutic Area Experience (Preferred): Cardiovascular, Metabolism, Diabetes, Lipid Disorders, CNS, Oncology, Anti-infectives, or Internal Medicine
Technical Skills:
Expertise in medical regulatory writing and strategic content creation
Strong time and risk management capabilities
Proficiency in handling clinical and regulatory documentation
Excellent written and verbal English communication skills
Soft Skills:
Strong stakeholder management
Effective team collaboration and ability to work independently
Estimated Salary: ₹18–₹28 LPA (based on role, experience, and industry benchmarks in India)
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