Cerner Enviza (an Oracle company) is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research.
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.
Cerner Enviza are looking for a One Year Maternity Cover Regulatory & Safety Project Manager for Real World Evidence and non-interventional studies. This role is a remote role to be based in the United Kingdom.
The Regulatory & Safety Project Manager will be primarily responsible for the daily tasks associated with the project management of regulatory engagements which includes accuracy of survey programming for content, skip logic, data checking, managing third party vendors and checking the work they produce, opening POs and invoices. They will be the central contact for routine study related issues, participation in creation of study documents, preparation of documents for submission and notification process, administration of invoices, may assist in monitoring tasks. The Regulatory & Safety Project Manager will overtake the main responsibility for a successful management of the submission and notification process in the countries participating in each study and for negotiation of contracts (sites, vendors etc.)
The successful candidate should have a Master´s Degree (or similar qualification) in Life Sciences, Pharmacy or Public Health or relevant professional education with an additional 3 years (minimum) of practical experience in RWE, regulatory and/or non-interventional studies focused on medicinal products and medical devices, preferably in a CRO(s). An epidemiological background will be highly recognized.