Expert Medical Regulatory Writer Job In Sanofi In Hyderabad / Secunderabad, Telangana, India

• 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

• 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

• 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)

• 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

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all

Sanofi is looking for .

Sanofi is looking for Any Graduate / Post Graduate profile candidates.