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, archiving (ie, 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 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 (eg, CSRs, IBs, PSURs) and also more complicated publishing projects (eg, datasets, CRFs, regional documents) for eCTD, NeeS and paper submissions.Compiling submissions and dispatches through Electronic submission gatewaysEnsuring acceptable format of documents received in Submission OperationsEnsuring the final submitted documents are physically (paper) and electronically archivedDeveloping, reviewing, maintaining, and disseminating publishing Service Level Agreements (SLAs) for different submission categories for efficient planning and resource management.Monitoring the development of new regulatory requirements or guidances and provides advice to Global Regulatory Operations and product teams of the impact on the business.Contributing to development and implementation of standards for dossier management, publishing, archiving and submission process for global regulatory authoritiesParticipating in selection and implementation of electronic Regulatory Document Management systemsParticipating in compliant and timely archiving of regulatory submissions and correspondences for Alexion productsAssisting the Submission Operations Lead in assessing impact of standards and requirements with a regional impact to existing and new systems.Working with GRO leadership to oversee strategic implementation of outsourcing services, when neededParticipating and shares lessons learnt sessions to encourage process improvement and efficiencies within and across submission project teams.Negotiating and agrees on realistic dates for document handoffs in collaboration with the project managers, authors, and submission managers.Assisting with other Regulatory Operations activitiesAssisting with training and development of all Regulatory Operations staffYou will need to have:BA in Regulatory Affairs or Equivalent Degree.Minimum 3 to 4 years of experienceThe duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving.#J-18808-Ljbffr
