IQVIA Global Regulatory Medical writer in Kochi, India
Regulatory medical writer :
• Secure delivery of high-quality medical/Safety/clinical documents (PBRER, ACO, CSR, Investigator brochure, clinical evaluation report, Briefing packages, Medical section of CTA) in time and in compliance with internal and external standards
• Responsible to provide medical assessment with relevant and updated clinical/safety evidence and to monitor the execution of strategic regulatory and labelling documents for the corresponding therapeutic area or products.
• Coordinates and supports medical/clinical activities related to the maintenance the marketing authorizations of the Novel/Established/Generics products, in different therapeutic areas
• Screening medical and scientific literature to substantiate safety and efficacy content
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency.
• Develops clinical expertise within Global Regulatory Affirms (on contents, methods, processes)
• Lead cross-functional communications to optimize feedback and input towards high quality documents. Maintain audit, SOP and training compliance.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas
• Master's Degree Degree in Lifescience or related discipline Req
• With at least 2 years of relevant medical writing experience
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Good, solid interpersonal communication (oral and written) and organisation skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office
• Demonstrates self-motivation and enthusiasm;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
• Ability to make decisions on discrete tasks under senior supervision;
• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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