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Global Medical Expert

5+ years
Not Disclosed
10 March 7, 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: Permanent
Posted on: March 4, 2025
Closing on: April 30, 2025

Our Team:

Sanofi Business Operations is an internal Sanofi resource organization based in India. It centralizes processes supporting Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital functions. The team acts as a strategic and functional partner for Medical, HEVA, and Commercial organizations globally.

Main Responsibilities:

  • Lead a team of medical regulatory writers and develop medical expertise in regulatory writing.
  • Ensure compliance with global regulatory requirements (FDA, EU, etc.).
  • Coordinate medical activities for marketing authorization maintenance across therapeutic areas.
  • Collaborate with Global Medical Leads, Regulatory Affairs, Pharmacovigilance, and vendors.

Essential Job Duties:

  • Conduct medical assessments and provide updated clinical evidence for strategic documents, including PBRERs, ACOs, DSURs, Benefit-Risk Assessments, and labeling documents.
  • Draft extended study synopses in collaboration with RWE experts.
  • Write key medical/clinical sections of Common Technical Documents (CTD) and Briefing Packages.
  • Review and approve compassionate use requests for Sanofi medicinal products.
  • Ensure timely, high-quality delivery of medical documents.
  • Work closely with global teams, regulatory affairs, and pharmacovigilance teams.

People Management:

  • Maintain relationships with medical, regulatory, and pharmacovigilance stakeholders.
  • Collaborate effectively with medical and pharmacovigilance departments.
  • Support knowledge-sharing within the medical regulatory writing team.

Performance & Process Improvement:

  • Secure timely and quality deliverables for regulatory submissions.
  • Provide medical strategic insights for Sanofi’s portfolio.
  • Manage marketing authorization dossiers for assigned products.
  • Act as an expert in medical regulatory writing and compliance.
  • Assist in regulatory writing needs analysis and medical communication planning.
  • Work with vendors and internal teams to ensure high-quality content.

Stakeholder Engagement:

  • Collaborate with regional and global medical teams to identify medical writing needs.
  • Work with the Medical department to ensure customized deliverables.

Qualifications & Experience:

  • Experience: ≥5 years in pharmaceutical industry (medical affairs, clinical development, pharmacovigilance) in therapeutic areas like cardiovascular, metabolism, diabetes, CNS, oncology, anti-infectives, or internal medicine.
  • Soft Skills: Strong stakeholder management, communication, and teamwork.
  • Technical Skills: Medical writing, operational excellence, time and risk management.
  • Education: MBBS or MD.
  • Languages: Excellent English (spoken and written).

About Sanofi:

At Sanofi, we are committed to progress through innovation and diversity. We provide equal opportunities to all individuals, regardless of background, and strive to make an extraordinary impact in healthcare. Learn more about our Diversity, Equity, and Inclusion initiatives at sanofi.com.