Operations Associate / Senior Operations Associate

As the global biologics research and development arm of AstraZeneca, MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic including respiratory, inflammation, and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.

Responsible for providing overall operational support in development, approval, and filing of clinical documents for regulatory submissions within the Medical Communication Department (MC). Works under general supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.

* Contributes to Clinical Study Report (CSR) Appendix 16 document collection, assembling, and uploading to the electronic document management system (EDMS) * Reviews and formats diverse regulatory documents in TRS/ISIWriter, MS Word, and Adobe Acrobat applications to meet submission-ready standards for global Health Authorities * Performs PDF checks and document cleaning activities to meet submission-ready standards for global Health Authorities * Tracks projects and files completed regulatory documents to the Trial Master File (TMF). * Participates in department, project, and MW Operations team meetings * Collaborates cross-functionally and contributes to continuous improvement within the MC Department and across the organization * Assists colleagues in document formatting troubleshooting and contributes to mentoring junior staff, if needed * Performs other operational support when needed

* Up to 1 year of experience in the medical writing or regulatory submissions field for pharmaceutical industry or CROs with the ability to format clinical, medical, and/or scientific documents as well as to do pdf checks * Proficiency in using Microsoft Office 2003-2013, Adobe Acrobat Professional, and TRS/ISIWriter Toolbox applications and working in EDMS environment * 2-3 years of work experience in the medical writing or regulatory submissions field for pharmaceutical industry or CROs with the ability to format clinical, medical, and/or scientific documents as well as to do pdf checks * Proficiency in using Microsoft Office 2003-2013, Adobe Acrobat Professional, and TRS/ISIWriter Toolbox applications and working in EDMS environment * Requires an undergraduate degree, preferably in a scientific discipline * General understanding of the drug development process, clinical regulatory document types, the principles of GXP and ICH guidelines, and applicable standards * Ability to identify and solve the problems * Ability to manage and prioritize multiple projects under general supervision and work in a fast-paced environment * High attention to detail * Strong written, verbal, and interpersonal communication skills * Experience working across multiple disease areas and technical disciplines is an asset