.Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.Publishing ManagerLocation: Barcelona, ESThis is what you will do:The Publishing Manager will be coordinating the publishing activities within GRO and will perform routine and nonroutine submission tasks, including publishing, scheduling, submission compilation, QC, validation, dispatch, and archiving of electronic and paper submissions (when needed) for Alexion's portfolio. The Publishing Manager will also work with Regulatory Sub-Teams and Submission Project Teams to provide guidance about electronic and paper submission requirements.The Publishing Manager will be responsible for publishing and preparation of high-quality global submission dossiers, ensuring Alexion delivers compliant submissions to global health authorities within required timeframes. All publishing staff will assist with the evaluation, development, and implementation of systems and processes used to support regulatory activities, including planning and tracking regulatory activities, document requirements, document management, publishing, and archiving (i.E., Regulatory Information Management). The Publishing Manager will be involved in mentoring and training junior publishers and others who will perform publishing tasks within GRO.The Publishing Manager will also work with the Regulatory Business System Support Lead (and other stakeholders, including IT) in planning and implementation of upgrades for publishing and validation system at Alexion. The Publishing Manager will act as the primary point of contact with Submission Managers for major projects when significant planning effort and oversight is required. The Publishing Manager will also assist the Submission Operations Lead in activities related to setting standards, best practices, KPIs collection, developing new procedures and work instructions, and lessons learned dissemination and will assist in other activities as needed. It is also expected that the Publishing Manager will be involved in dossier management and archiving activities within GRO.You will be responsible for:Managing overall publishing activities within GRODistributing publishing tasks among publishers and makes assignmentsTraining publishers on routine and more complicated tasksPublishing both routine (e.G., CSRs, IBs, PSURs) and also more complicated publishing projects (e.G., datasets, CRFs, regional documents) for eCTD, NeeS, and paper submissions
