Ravishankar Babu
Associate Director, Medical Writing @ICON plc
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WORK HISTORY
Associate Director, Medical Writing @ICON plc
Paris, FR
Responsible for overseeing medical writing budgets, planning, and implementation Manage Medical Writing teams in Europe, the UK, and India, including staff line management Drive and promote organizational process improvement initiatives, encouraging team members to initiate process improvements Review, approve, create, and revise standard operating procedures (SOPs) as needed Build and maintain relationships with internal and external customers, attend client meetings, write and review proposals, price deliverables, attend bid defense meetings, and contribute to contracts and work orders Develop and review financial forecasts and monitor revenue, costs, and utilization Provide regular business updates to senior leaders Collaborate with internal colleagues to improve quality and efficiency across projects and the organization Develop and participate in department training Participate in capacity planning, productivity goals, and set departmental and staff-level expectations Support the implementation of process changes as necessary
EDUCATION
Sikkim Manipal University - Distance Education
Master of Business Administration - MBA
Stanford University
No-Code AI: Unlocking Business Potential, Artificial Intelligence
Indian Law Institute
Certificate Course on IPRs, -Intellectual Property Rights and Information Technology in the Internet Age
Indo-American Hybrid Seeds pvt. Ltd
Certificate Course, Immunological Techniques & Plant Tissue Culture
Kendriya Vidyalaya
Higher Secondary School Certificate, Science
University of Mumbai
Master of Science (M.Sc.), Microbiology, General
University of Mumbai
Bachelor of Science (BSc), Microbiology, General
IPI academy
Pharma 'Mini-MBA'
Sangene Institute of Biosciences
Advanced Diploma, Molecular Biology & Recombinant DNA Technology
University of Mumbai
Doctor of Philosophy (PhD), Microbiology
SKILLS
ABOUT RAVISHANKAR BABU
I\'m a seasoned manager with 19+ years of expertise in overseeing medical writing and regulatory affairs projects across all phases of drug development, spanning various therapeutic areas and geographies. My experience includes handling a wide array of medical writing tasks, both as a service provider and within sponsor companies.I hold a Ph.D. in microbiology and excel as a medical writer, preparing a diverse range of regulatory, disclosure, and scientific documents. My portfolio includes clinical study reports, protocols, clinical overviews and summaries, abstracts, manuscripts, review articles, patient information and consent forms, narratives, safety reports, risk management plans, pediatric investigation plans, agency responses, briefing packages, FDA advisory committee briefing documents, Investigator Brochures, Annual Reports, result summaries, EU results summaries, and protocol summaries for CT.gov and the EU. I\'ve contributed to various therapeutic areas, such as oncology, metabolic and endocrine disorders, renal, immunology, gastrointestinal, respiratory, infectious diseases, and neuroscience.Additionally, I am a proficient manager with excellent people management skills, adept at motivating teams to consistently achieve exceptional results. As a detail-oriented professional with outstanding communication skills, I am flexible and efficient in managing multiple priorities within tight deadlines.
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