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Global Medical Expert

1-5 years
Not Disclosed
10 April 4, 2025
Job Description
Job Type: Full Time Education: Medical degree 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

 


Job Title:

Global Medical Expert

Company:

Sanofi

Location:

Hyderabad / Mumbai, India

Job Type:

Permanent, Full-time

Grade:

Not Applicable (NA)

Hiring Manager:

Head Scientific Communications / Team Lead

Travel Requirements:

As per business need


About the Team:

Sanofi Business Operations (SBO), based in India, is a centralized organization supporting:

  • Specialty Care

  • Vaccines

  • General Medicines

  • Consumer Healthcare (CHC)

  • Contract Manufacturing (CMO)

  • R&D, Data & Digital

SBO functions as a strategic and functional partner for Medical, HEVA, and Commercial teams globally.


Main Responsibilities:

Medical Expertise & Project Oversight:

  • Lead and guide medical regulatory writing activities and content development.

  • Ensure global compliance (FDA, EU, etc.) for all supported regulatory documents.

  • Coordinate activities related to maintaining marketing authorizations across various therapeutic areas.

  • Collaborate with stakeholders including Global Medical Leads, Regulatory Affairs, Pharmacovigilance, and vendors.

Medical Writing & Document Ownership:

  • Conduct medical assessments and clinical evidence evaluations for documents like:

    • PBRERs, DSURs, ACOs, MDDs, HAQs, CTDs, Clinical Overviews, Benefit-Risk Assessments, Expert Statements, Labeling Documents, Briefing Packages.

  • Oversee execution of study synopses in collaboration with RWE teams.

  • Review/approve compassionate use cases of Sanofi products outside of trials.

  • Secure on-time delivery of high-quality, regulatory-compliant documents.


People & Performance Management:

People:

  • Build strong relationships with medical, regulatory, and pharmacovigilance teams.

  • Provide guidance and share expertise with junior writers and medical teams.

Performance:

  • Ensure timely and high-quality delivery of regulatory and clinical documents.

  • Ensure that deliverables meet internal standards and regulatory expectations.

Process:

  • Provide strategic insights and evaluations related to Sanofi’s product portfolio.

  • Contribute to the development of marketing authorization dossiers.

  • Lead the implementation of medical regulatory plans and activities for assigned regions.

  • Collaborate with vendors and ensure SOP and GCP compliance.

  • Assist in planning, feedback analysis, and process improvement strategies.

Stakeholder Collaboration:

  • Align with medical teams across regions to assess and fulfill regulatory writing needs.

  • Ensure deliverables are tailored and meet the expectations of internal stakeholders.


About You:

Experience:

  • ≥5 years in international pharmaceutical environments, with a background in:

    • Medical Affairs

    • Clinical Development

    • Pharmacovigilance

  • Therapeutic area expertise in: Cardiovascular, Metabolism, Diabetes, CNS, Oncology, Anti-infectives, Internal Medicine

Education:

  • Medical degree (MBBS or MD)

Soft Skills:

  • Strong stakeholder engagement

  • Excellent communication

  • Independent and collaborative work style

Technical Skills:

  • Medical operational excellence

  • Time and risk management

  • Exceptional technical medical writing and editing abilities

Languages:

  • Excellent English (spoken and written)


Diversity & Inclusion at Sanofi:

Sanofi is committed to fostering an inclusive workplace. All qualified applicants will be considered regardless of background, race, religion, gender, orientation, age, or disability.