Regulatory Affairs Specialist - Reg Intelligence

Detalles de la oferta

.At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.**Regulatory Affairs Specialist - Reg Intelligence****Responsibilities**:- Quality checks information in the Regulatory Intelligence database for readability, consistency and accuracy against regulatory agency guidance.- Keeps colleagues informed of delayed, missing or incomplete intelligence; ensure follow-up and completion of all action are performed in a timely manner.- Proactively communicates with and supports in-country associates to ensure global regulatory intelligence remains accurate.- Proactively monitors the global regulatory environment for regulatory intelligence updates to support the regulatory intelligence screening process.- Supports business development activities by downloading/creating reports from the RI database, and/or seeking input from in-country associates.- Generates MS PowerPoint slides & reports in MS Excel & MS Word as requested by RIPA management.- Supports RIPA management in the administration of agreed regulatory intelligence activities.**Education and Experience**:- Bachelor's degree in Science or equivalent and relevant formal academic / vocational qualification- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)- Previous experience working in the pharmaceutical/ CRO industry would be an advantage**Knowledge, skills and abilities**:- General knowledge of global/ regional/ national country requirements is an asset; - Very good English language skills; - Ability to read, analyze and interpret general, scientific and business periodicals, governmental regulations; - Computer skills (Microsoft office); - Good organizational and planning skills; - Excellent attention todetail and ability to identify trends, gaps etc.- Ability for multiple project tasking; - Ability to work effectively in a team environment.- Global exposure and cultural awareness are a plus.**What we offer**:At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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