Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Post : Expert Medical Regulatory Writer
Job Description
Job summary
Write and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities including complex Clinical Study Reports (CSR), complex CTD submission documents (clinical overview (CO), summary of clinical efficacy (SCE), clinical safety (SCS), clinical pharmacology (SCP), and biopharmaceutics (SBP)), medical section of Periodic Benefit-Risk Evaluation Report (PBRER), addendum to clinical overview (ACO), Risk Management Plans (RMP), ID Cards, clinical evaluation report, Briefing packages, responses to Health Authorities Queries, and immunogenicity reports.
Job duties and responsibilities
• Leading complex submissions, contributing to key messaging meetings, providing expert content guidance for medical sections of CTD, and delivery of high-quality medical documents in time and in compliance with internal standards and external guidelines.
• Participate in the planning of analysis and data presentation to be used as an ad-hoc member of the Clinical Trial Team (CTT), a core member of the Clinical Submission Teams (CST), and an extended member of the Global Clinical teams (GCT) and Safety management team (SMT)
• Develops and maintains TA expertise and provides document-related advocacy to other line functions
• Reviews content created by peer writers and act as a coach, mentor, and trainer for the development of writers for the new document type
• Work with minimal supervision and support development of medical regulatory writers
• Agile and knowledgeable to be able to work across therapeutic areas.
• Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, CTT, CST, GCT, and SMT
Candidate Profile
• Advanced degree in life sciences/ pharmacy/ similar discipline (Phd, Masters, or bachelor’s in science, D.Pharms) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
• Excellent English language knowledge (Spoken and Written)
• Therapeutic area/domain knowledge exposure (including but not limited to): Diabetes, Familial hypercholesterolemia, Cardiovascular disease, Multiple sclerosis, Immunology, Oncology, Market access, Emerging markets, Generics, Vaccines, Vitamins and supplements, Digestive, Allergies, Parkinson, Haemophilia, Rare diseases, and rare blood diseases
• Stakeholder management
• Project management
• Regulatory Procedures
Any other requirements of the job
• ≥8 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
• Expert knowledge of and demonstrated accomplishment in global registration of drugs
• Excellent communication skills (written, verbal, and presentation)
• Substantial knowledge of biostatistics principles
• Experience in managing global, cross-functional teams and working in a Matrix environment
• Demonstrated ability to motivate, coach or mentor people.
Additional Information
Experience : ≥8 years
Qualification : M.Pharm, MSc, Ph.D, D.Pharm, MBBS, BDS, BAMS, BHMS, MD
Location : Hyderabad
Industry Type : Pharma
End Date : 30th April, 2023
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