.This job is with Thermo Fisher Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 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.We are seeking a Sr Label Coordinator to join our Global Clinical Supplies Team.The role can be based in Spain, Croatia, France or Ireland.Role overview Acts as a liaison and support to the local team in all areas of clinical supplies lifecycle (i.E., receipt, storage & handling, shipment & delivery, return & and accountability, destruction coordination) for assigned studies, ensuring compliance with requirements.A day in the life: Ensures all activities are driven in compliance with company good practices and client requirements.Completes ongoing training on new regulations concerning clinical supplies and Gx P activities.Participates in and supports department project teams, including development clinical supply strategy.Assists in the development and suggestion of improvements to update departmental SOPs.May train or assist junior staff.Plans and coordinates label, patient card, and dosing card activities.Ensures activities are completed as needed according to PPD SOP requirements and/or client requirements.Coordinates the preparation and regulatory approval of information to be included on labels, patient cards and dosing cards in clinical trials.Reviews source documents and requests for quotes.Assists with the development and maintenance of the Global Labeling Management tool as per SOP-CS-38 and the Translation Glossary.Takes on complex projects.Takes on Initiatives outside of project work such as process improvements, SMEs, training.Providing cover for Manager during periods of absence (leave, sickness).making recommendations.Keys to success: Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years)
