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Global Medical Expert

5+ years
₹18–₹28 LPA
10 July 28, 2025
Job Description
Job Type: Full Time Education: MBBS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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)