Sanofi is committed to helping people overcome their health obstacles. We are a multinational biopharmaceutical business with a focus on people’s health. We use vaccines to prevent illness, and we offer cutting-edge pain relief and suffering reduction treatments. We support both the millions of people with chronic long-term illnesses and the few who have rare diseases. Our company reinvents how we work, changes the way medicine is practised, and empowers individuals to reach their full potential in both their professional and personal lives. We make sure that our employees grow along with us as we move and expand regularly. Our workplace enables individuals to lead the lives they choose while assisting us in creating a dynamic, inclusive workplace built on respect and trust.
Designation: Medical Regulatory Writer
Qualifications:
1. 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).
2. Excellent English language knowledge (Spoken and Written).
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.
Essential 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
Knowledge, Skills & Competencies / Language
- 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
