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Safety Writing Scientist (UK)
Location:
Slough
Description:
Make your mark for patients We are looking for a Safety Writing Scientistto join us in our Patient Safety and Medical Managementteam, based in any of our Brussels (Belgium), Slough (UK) or Raleigh (US) offices. About the role Scientific analysis and writing acumen to effectively articulate for benefit: risk backssments, safety risk management strategies, safety signal backssments, regulatory submissions, aggregate reports, and publications. Lead, project manage, and contribute to projects (including mentoring of vendor) as assigned to deliver the project in accordance with global regulatory submission requirements (for external documents), within planned timelines (and budget as appropriate), and according to required standards of quality and compliance. As assigned, lead a hub of expertise in the Safety analysis and writing team on an area of interest for the Patient Safety Medical Management team, which may include technical oversight of vendor or processes, being Subject Matter Expert on key activities, etc Who you'll work with You will report into the Senior Safety Writing Scientist Team Lead What you'll do : Lead preparation of Patient Safety and Medical Management deliverables, including planning, contributing to analysis strategy, writing, presentation when necessary, and review/approval of documents and deliverables in scope which include DSUR, SMR, PSUR, SSAR, RMP, PAER, BRAMS document, regulatory responses, submission documents, relevant and other regulatory/safety annual reports.Provide mentorship to relevant vendors and oversee the work, ensuring the final deliverables meet the UCB quality guidelines.Perform literature review and summary of literature for AR, RMP, epidemiology, product renewals, safety evaluations: Assure quality and consistency across Patient Safety and Medical Management deliverables, including compliance with regulatory requirements and compliant with agreed and defined timelines: Prepare ECMS templates to be compliant. Visit ListedBuy for more information.
Posted:
April 23 on ListedBuy
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Safety Writing Scientist (UK) is a Other Art & Media Jobs Scientist Job located in United States. Find other listings like Safety Writing Scientist (UK) by searching Oodle for Other Art & Media Jobs Scientist Jobs.