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Global Medical Expert

5+ years
Not Disclosed
10 March 31, 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 – Hyderabad, India
Location: Hyderabad/Mumbai
Type: Permanent, Full-time
Posted on: Mar. 17, 2025
Expires on: Apr. 30, 2025

About the Job

Our Team:
Sanofi Business Operations is an internal Sanofi resource organization based in India, set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital functions. It strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations globally.

Main Responsibilities:

  • Work with a team of medical regulatory writers and develop expertise in Medical Regulatory Writing (content, methods, and processes).

  • Ensure compliance with regulatory requirements from various regions (FDA, EU, and others).

  • Coordinate and support medical activities related to maintaining marketing authorizations of Established and Generic products across therapeutic areas.

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

Essential Job Duties and Responsibilities:

  1. Provide medical assessment with relevant and updated clinical evidence.

  2. Monitor the execution of strategic documents such as PBRERs, DSURs, Clinical Overviews, Benefit-Risk assessments, and more.

  3. Draft extended study synopses with RWE experts and oversee execution in compliance with SOP, GCP, and other regulations.

  4. Write key medical/clinical parts of Common Technical Documents (CTD) or Briefing Packages (BP).

  5. Review and approve compassionate use requests for Sanofi medicinal products.

  6. Ensure the delivery of high-quality medical documents on time and in compliance with standards.

  7. Collaborate effectively with stakeholders including global medical leads, medical regulatory writing teams, and pharmacovigilance teams.

People Management:

  • Maintain effective relationships with the medical, regulatory, and pharmacovigilance community.

  • Interact with stakeholders to ensure high-quality deliverables.

  • Assist the medical regulatory writing team in developing knowledge and sharing expertise.

Performance and Process Management:

  • Ensure deliverables are met on time and with high quality.

  • Provide strategic medical insights and contribute to managing marketing authorization dossiers.

  • Assist the head of scientific communications in designing an overall action plan based on stakeholder feedback.

Stakeholder Management:

  • Identify medical writing needs with regional medical teams and develop assigned deliverables.

  • Liaise with medical teams to ensure that relevant and customized content is delivered as expected.

About You

  • Experience: ≥5 years in supporting international pharmaceutical companies in medical affairs, clinical development, or pharmacovigilance, with experience in therapeutic areas such as cardiovascular, metabolism, diabetes, CNS, oncology, or anti-infectives.

  • Soft Skills: Stakeholder management, strong communication skills, and ability to work independently and within a team environment.

  • Technical Skills: Medical operational excellence, time and risk management, and strong medical editing and writing skills.

  • Education: Medical degree (MBBS or MD).

  • Languages: Excellent knowledge of English (spoken and written).

Pursue Progress, Discover Extraordinary

Better is out there – better medications, better outcomes, and better science. Progress happens because of people from diverse backgrounds coming together to make a difference.

Sanofi is an equal opportunity employer.

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