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:
Provide medical assessment with relevant and updated clinical evidence.
Monitor the execution of strategic documents such as PBRERs, DSURs, Clinical Overviews, Benefit-Risk assessments, and more.
Draft extended study synopses with RWE experts and oversee execution in compliance with SOP, GCP, and other regulations.
Write key medical/clinical parts of Common Technical Documents (CTD) or Briefing Packages (BP).
Review and approve compassionate use requests for Sanofi medicinal products.
Ensure the delivery of high-quality medical documents on time and in compliance with standards.
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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