Reference No. R2652037 Position Title: Operations Coordinator Department: Regulatory Affairs Location: Mississauga NOTE: Role is based in Mississauga, Ontario About Sanofi - www.sanofi.ca Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi entities in Canada include Sanofi Genzyme (Specialty Care), Sanofi Pasteur (Vaccines), General Medicines and Consumer Healthcare. Together we employ approximately 2,000 people. In 2019, we invested $131 million R&D in Canada, creating jobs, business and opportunity throughout the country. Sanofi Canada consolidates its commercial offices into a state-of-the-art facility in Toronto. Discover your future at Sanofi in areas such as medical, regulatory, commercial and many more. When we recruit new talent, we see it as a fresh start to build their career with Sanofi. If you join us, be prepared to take on new professional opportunities, explore innovative ideas and contribute to our ambition to change the practice of medicine. You will be part of a flexible and inclusive workplace - based on trust and respect - so you can live your life the way you want to. Position Summary: The Operations Coordinator is the RA department Subject Matter Expert (SME) for Health Canada (HC) invoice fees processing and assisting with HC submission fees budgeting, as well as setting up vendor contracts. Lead to assess and assign department training, as well as coordinate workflow of and support development of local department work processes. In charge of translation process and ensuring current Canadian patent information maintained. This position is the main contact overseeing logistics preparations for all Health Canada in-person meetings and also coordinates other logistical and operational activities within the regulatory department. Key Responsibilities: - Process all Health Canada and other Regulatory Department invoices on a timely basis. Independently work to trouble-shoot any Health Canada invoice issues. - Assist with budget planning of health authority submission fees (approximately $4 million Canadian) by tracking expected submission workload. - Key user for P2P tools such as eBuy, Easy Invoices, eContract, Aravo, My Supplier Portal. - Set up new / extend current contracts and purchase orders with third-party vendors; track monthly accruals. - Monitor group mailbox and electronically file all Health Canada correspondence in internal database systems (eg Vault). SME for health authority correspondence filing, independently providing all meta-data information and linking to appropriate submissions. - Document policies, procedures and workflow for assigned areas of responsibility. - Main lead with translation vendor and responsible for posting approved Product Monographs on external company website. - Lead in assignment of training to all Regulatory Affairs members and maintenance of current training curriculum. - Accurately complete and file Annual Drug notification forms (to Health Canada) , coordinate CPS (Compendium of Pharmaceuticals and Specialties) listings (external publisher). - Contribute to department and organization special projects as assigned. Key Requirements: - Completed an office administration diploma or equivalent combination of education and experience. BA/BSc preferred. - A minimum 2 years of relevant experience. - Excellent planning and organizational skills. - Attention to detail and deadline driven. - Excellent oral and written communication skills, and interpersonal skills. - Strong computer skills -including proficiency in the Microsoft Office Suite. - Flexibility and ability to prioritize. - Works well independently as well as in a group environment. - MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat. - Veeva Vault database familiarity is an asset. Languages: - English (written and spoken). - French is an asset. Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Follow Sanofi on Twitter: @SanofiCanada (https://twitter.com/SanofiCanada) and on LinkedIn: https://www.linkedin.com/company/sanofi . Sanofi, Empowering Life #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.