Global Regulatory Medical writer

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

Qualifications
• 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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.