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Global Medical Expert

5+ years
Not Disclosed
10 Dec. 13, 2024
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

Job Title: Global Medical Expert
Location: Hyderabad / Mumbai
Job Type: Permanent, Full-time
Hiring Manager: Head, Scientific Communications / Team Lead
Travel: Travel required as per business need

About Sanofi Business Operations

Sanofi Business Operations is an internal organization based in India, centralizing processes and activities to support various functions, including Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D. We aim to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial teams across Sanofi globally.

Main Responsibilities:

As a Global Medical Expert, you will play a crucial role in providing medical assessments, drafting key documents, and supporting regulatory activities related to the maintenance of marketing authorizations. Your responsibilities include:

Medical Expertise and Document Management:

  • Provide medical assessments with up-to-date clinical evidence for strategic documents like PBRERs, ACO, DSURs, Clinical Overviews, Benefit-Risk assessments, and Expert statements for MDD.
  • Draft extended synopses of studies in collaboration with RWE experts and oversee execution plans in compliance with SOP, GCP, and other regulations.
  • Write key medical and clinical sections of CTD and Briefing Packages.
  • Review and approve requests for compassionate use of medicinal products in serious or life-threatening diseases.
  • Ensure timely and high-quality delivery of documents that comply with internal and external standards.

Stakeholder Collaboration:

  • Collaborate with Global Medical Leads, Global Regulatory Affairs, Pharmacovigilance, and other teams to create and review medical regulatory content.
  • Maintain effective relationships with stakeholders within medical, regulatory, and pharmacovigilance teams.

Performance & Process Management:

  • Secure timely delivery of medical documents such as PBRER, ACO, CSR, ID Cards, Investigator brochures, clinical evaluation reports, and medical sections of CTA.
  • Contribute to the management of marketing authorization dossiers for Sanofi's portfolio.
  • Provide medical strategic insights and assist in conducting medical regulatory writing-needs analyses.
  • Collaborate with vendors to ensure the delivery of required documents as per the defined processes.

Leadership & Development:

  • Assist the Head of Scientific Communications in designing action plans based on customer feedback and improve course content and delivery.
  • Share expertise and assist the team in developing knowledge in medical regulatory writing.

About You:

Experience:

  • ≥5 years of experience supporting international pharmaceutical companies in medical affairs, clinical development, or pharmacovigilance. Experience in at least one of the therapeutic areas: Cardiovascular, Metabolism, Diabetes, CNS, Oncology, Anti-infectives, or Internal Medicine.

Education:

  • Medical degree (MBBS, MD).

Skills:

  • Strong stakeholder management and communication skills.
  • Ability to work independently and collaborate effectively in a team environment.
  • Excellent technical skills in medical editing and writing.
  • Medical operational excellence, time, and risk management skills.

Language Skills:

  • Fluency in English (both written and spoken).

Why Sanofi?

At Sanofi, we believe in making miracles happen by pursuing progress together. We provide equal opportunities for all and support diversity, equity, and inclusion in the workplace. Join us to explore extraordinary opportunities and help us make a meaningful difference in the world of healthcare.

Pursue Progress. Discover Extraordinary.

Sanofi is an equal opportunity employer, embracing diversity in all its forms, and committed to fostering an inclusive and supportive work environment.