Job title: Senior Medical Regulatory Writer
Location: Hyderabad, Mumbai
Hiring Manager: Head Scientific Communications/ Team Lead
% of Travel Expected: Travel required as per business need
Job type: Permanent and Full-time
About the Job:
Our Team:
Sanofi Business Operations is an internal Sanofi resource organization based in India and is set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
Main Responsibilities:
Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to Clinical Overviews, Clinical Study Reports (CSR), Disease and Product ID Cards, Clinical Evaluation Reports, product alerts, and trial transparency documents.
Deliver high-quality medical documents on time, in compliance with internal and external standards and guidelines.
Work independently on documents with minimal supervision and act as a buddy or mentor to medical writers.
Efficiently peer review content created by peers.
Essential Job Duties and Responsibilities:
Document Planning: Participate independently in the planning of analysis and data presentation.
TA Expertise: Develop and maintain therapeutic area (TA) expertise.
Content Review: Review content created by peers.
Collaboration: Collaborate effectively with global or local teams, including Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, Regulatory, and Corporate Affairs teams.
People:
Maintain effective relationships with the medical and scientific community globally.
Interact effectively with stakeholders in medical and pharmacovigilance departments.
Assist other medical regulatory writers in developing knowledge and sharing expertise.
Performance:
Provide deliverables such as PBRER, ACO, CSR, Product and Disease ID Cards, Clinical Evaluation Reports, Briefing Packages, Medical sections of CTA, managing Product Alerts, and trial transparency documents as per agreed timelines and quality standards.
Process:
Author, review, and act as an expert in medical regulatory writing while maintaining regulatory compliance.
Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.
Implement relevant elements of the medical regulatory plan.
Design an overall plan of action based on customer feedback and improve course content and delivery.
Prepare/review standby statements and Q&A documents as part of managing Product Alerts.
Track postings, file, or archive material in relevant systems and ensure audit and inspection readiness.
Stakeholders:
Work closely with Clinical/Medical teams to identify medical writing needs and assist in developing deliverables.
Proactively liaise with relevant departments including Clinical, Medical, Pharmacovigilance, Biostatistics, Regulatory, Legal, and Corporate Affairs.
About You:
Experience:
5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry.
Soft Skills:
Stakeholder management, vendor management, communication skills, and ability to work independently and within a team.
Technical Skills:
Medical operational excellence, time, and risk management skills.
Excellent technical (medical) editing and writing skills.
Data retrieval, interpretation of scientific data, medical literature screening.
Knowledge of ICH and GCP/GVP guidelines.
Ability to summarize scientific information and edit text for specific audiences.
Proficiency in computer applications.
Education:
Advanced degree in life sciences/pharmacy/similar discipline (PhD, Masters, or Bachelor’s in Science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD).
Languages:
Excellent command of English, both written and verbal.
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Bridgeport | Bristol | Enfield | Groton | Hartford | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
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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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Dickinson |northeastern :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
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China | Quarry Bay |Hubei :
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Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
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Remote - Middle East | Remote - Europe | Remote, USA | Remote - Africa | Remote - South America (Latin Americal) | Remote | Switzerland |Bucharest :
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Riyadh | Najran | Rabigh | Khulais | Jeddah | King Abdullah Economic City |Nišava District :
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