Global Medical Expert
Location: Hyderabad, India
Type of Work: Full time
Company Overview:
Sanofi is a global healthcare leader committed to pursuing the miracles of science to improve people’s lives. With operations in over 90 countries and a workforce of 91,000 employees, Sanofi delivers breakthroughs across immunology, chronic disease care, vaccines, and more, backed by cutting-edge technology and digital innovation.
Team Overview:
Sanofi Business Operations (SBO) in India supports global Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. SBO partners strategically with Medical, HEVA, and Commercial organizations to enable tactical excellence across operations.
Main Responsibilities:
Medical Regulatory Writing and Support:
Develop medical expertise within the regulatory writing team across content, methods, and processes.
Ensure compliance with global regulatory requirements (FDA, EU, and others).
Coordinate and support medical activities related to the maintenance of marketing authorizations for Established and Generic products.
Collaborate with Global Medical Leads, Regulatory Affairs, Pharmacovigilance, and external vendors.
Essential Job Duties and Responsibilities:
Provide medical assessments with updated clinical evidence for strategic documents including PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk Assessments, Expert Statements, and more.
Draft extended study synopses in collaboration with RWE experts and oversee execution in compliance with SOPs and GCP regulations.
Author key medical/clinical parts of Common Technical Documents (CTDs) and Briefing Packages (BPs).
Review and approve compassionate use requests for serious/life-threatening conditions outside clinical trials.
Ensure delivery of high-quality medical documents within timelines and in compliance with internal/external standards.
Collaborate with stakeholders including Global Medical Leads, Global Regulatory Affairs, Pharmacovigilance, and Managed Access Program teams.
Stakeholder and People Management:
Develop and maintain effective relationships with Medical, Regulatory, and Pharmacovigilance stakeholders globally.
Support the medical regulatory writing team with knowledge development and expertise sharing.
Performance and Process Excellence:
Secure deliverables related to PBRER, ACO, SO, CSR, ID Cards, Investigator Brochure, CER, BPs, and others as per quality and timeline expectations.
Provide strategic medical insights and evaluations for Sanofi’s portfolio.
Act as a regulatory writing expert, ensuring compliance with evolving country-specific requirements.
Support comprehensive needs analysis and contribute to the yearly medical regulatory writing plan.
Collaborate with vendors to ensure quality outputs according to processes.
Assist in continuous improvement initiatives based on customer feedback.
Stakeholder Collaboration:
Partner with regional and global medical teams to identify and fulfill medical writing needs.
About You:
Experience:
Minimum 5 years of experience supporting international pharmaceutical companies in medical affairs, clinical development, or pharmacovigilance.
Therapeutic area experience in cardiovascular, metabolism, diabetes and lipid, CNS, oncology, anti-infectives, or internal medicine.
Soft Skills:
Strong stakeholder management and communication skills.
Ability to work independently and within collaborative team environments.
Technical Skills:
Medical operational excellence.
Expertise in time and risk management.
Exceptional technical (medical) editing and writing skills.
Education:
Medical Degree (MBBS; MD).
Languages:
Excellent spoken and written English.
Equal Opportunity Statement:
At Sanofi, diversity is the foundation of innovation. We provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
For more, watch our ALL IN video and explore our Diversity, Equity, and Inclusion initiatives at sanofi.com.
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Birmingham |Alaska :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Wilmington |Florida :
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Atlanta | Augusta | Rome |Hawaii :
Hilo | Honolulu |Idaho :
Boise |Illinois :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
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Germany | GErmany |Hesse :
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Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
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Bulgaria |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
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Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
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Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
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Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Renfrew | Australia | Richmond Hill | Uxbridge | Mississauga | North York |Quebec :
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Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
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Tallinn |Chuuk :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
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Surabaya |Jakarta :
Jakarta |Israel :
Be'Er Sheva | Tel Aviv | Yavne | Kfar Saba | Netanya |Italy :
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Almaty |Remote Korea :
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Remote - Europe | Melbourne | Remote | Remote - South America (Latin Americal) | Victoria | Remote - Middle East | Switzerland | Zaragoza | McFarland | Remote - Africa | Remote, USA | Lenexa | Leinster |Bucharest :
Bucharest |Makkah :
Riyadh | Najran | Khulais | King Abdullah Economic City | Jeddah | Rabigh |Nišava District :
Niš |Singapore :
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Midrand | South Africa |Brazil :
Brazil | Sao paulo |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
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Sweden |Taipei :
Taipei |Williamson :
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Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |