Job Description

Location: Mississauga, Canada Job reference: R-206733 Date posted: 08/09/2024Position SummaryThe Publishing Manager is accountable for leading and coordinating the publishing activities within GRO for routine and non-routine submission tasks including publishing, scheduling, submission compilation, QC, validation, dispatch and archiving of electronic and paper submissions (when needed) for company portfolio. They are responsible for publishing and preparation of high quality global submission dossiers, ensuring Alexion delivers compliant submissions to global health authorities within required timeframes.The Manager will act as the primary point of contact for project and/ or submission teams (including Regulatory Submission Project Management) for major projects when significant planning effort and oversight is required. They will provide technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submissions including\xc3\x82 guidance about electronic and paper submission requirements.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 individual will be involved in dossier management and archiving activities within GRO, including mentoring and training junior publishers and others who will perform publishing tasks within GRO.All publishing staff will assist with the evaluation, development, and implementation of systems and processes used to support regulatory activities, including planning and supervising regulatory activities, document requirements, document management, publishing, archiving (i.e. Regulatory Information Management). The Publishing Manager will also work with the Regulatory Business System Support Lead (and other collaborators, including IT) in planning and implementation of upgrades for publishing and validation system at Alexion.Principal Responsibilities:Manages overall publishing activities within GRO;Assists with training publishers on routine and more complicated submissions and development of new members in the team.To prepare and submit all type of regulatory submissions ( eg. IND updates, CSRs, Type I/II variatons, Advertising and Promotional Material submissions, NeeS and Paper )Compiles submissions and dispatches through Electronic submission gateways;Ensures acceptable format of documents received in Submission Operations;\xc3\x82Ensures the final submitted documents are physically (paper) and electronically archived;\xc3\x82Develops, reviews, maintains and disseminates publishing Service Level Agreements (SLAs) for different submission categories for efficient planning and resource management;\xc3\x82Monitors the development of new regulatory requirements or guidance\xc3\xa2\xc2\x80\xc2\x99s and provides advice to Global Regulatory Operations and product teams of the impact on the business;\xc3\x82Contributes to development and implementation of standards for dossier management, publishing, archiving and submission process for global regulatory authorities;\xc3\x82Participates in selection and implementation of electronic Regulatory Document Management systems;\xc3\x82Participates in compliant and timely archiving of regulatory submissions and correspondences for Alexion products;\xc3\x82Assists the Submission Operations Lead in assessing impact of standards and requirements with a regional impact to existing and new systems;\xc3\x82Works with GRO leadership to be responsible for strategic implementation of outsourcing services, when needed;\xc3\x82Ensures SOP adherence, application of standard processes, oversight of contractors and CROs, and customer/team member interactions, and overall vendor management activities;\xc3\x82Participates and shares lessons learnt sessions to encourage process improvement and efficiencies within and across submission project teams;Negotiates and agrees on realistic dates for document handoffs in collaboration with the authors, regulatory submission project managers and publishers;As a global publishing expert, ensures the submission project team has sufficient awareness and knowledge on the application of e-submission (eCTD, NeeS, etc.) requirements and lifecycle management concepts and communicates regional differences (general formatting, template adherence, submission standards and procedures and version control) for their specific submission, within the context of global submission preparation;Assists with other Regulatory Operations activities like submission process improvements.Qualifications:A minimum of 4 years of experience in regulatory affairs/operations within the pharmaceutical industry.Strong verbal and written communication and presentation skills. A strong training skill is a plus.Strong communication skills and ability to work effectively and establish relationships with cross-functional teams.Self-motivated and results-oriented with high energy driveVery knowledgeable in CTD/eCTD structure and requirements and a good understanding of submission requirements for global submission types (e.g. IND, BLA, MAA, NDS, CTA, PSUR etc.).Solid experience in publishing and compilation of eCTD submissions for US and EU filings is required and experience publishing electronic submissions in other regions is desirable.Solid understanding of Microsoft Office suite, Sharepoint, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools.Knowledge and experience working in Veeva Vault submission and content planning is desiredIn-depth knowledge of StartingPoint templates.Demonstrated project management, organizational and planning skills.Ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines.Ability to work independently (with minimal direction), and in a team environment with changing timelines and priorities.Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines.Experience with submission deliverable dependencies and ability to reflect this in project plan in order to create and maintain detailed submission schedules (as MS-Project tasks).Understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are met on a timely manner and to the highest quality.Experience with core dossier concepts and global document reusability is desirable.Prior publishing and archiving experience is highly desirable and preferredEducation:A minimum of a Bachelor\xc3\xa2\xc2\x80\xc2\x99s degree in a scientific or technical field is required; equivalent experience may be accepted.A minimum of 4 years pharmaceutical or other related proven experience with 1-3 years of regulatory submission management experienceCompetencies:Excellent experience and familiarity with electronic publishing (eCTD) software, Regulatory Information \xc3\x82 and content/document management tools.Familiarity with submission and drug/biologic development dossier concepts;A firm grasp and understanding of the global eCTD.Good organizational and project management skills.Good knowledge of quality control procedures and methods related to processing of electronic and paper submissions, when needed.\xc3\x82Strong experience with management of electronic (and paper) archival file records for correspondence with regulatory agencies, formal submissions, etc.Great interest and ability for trainingAlexion CanadaSince beginning our operations in Canada in 2009, Alexion has been working tirelessly to bring innovative medicines to the millions of Canadians living with rare diseases. Our pioneering 30-year legacy, our scientific expertise and our commitment to patient-centric decision-making are the foundations of what we are today \xc3\xa2\xc2\x80\xc2\x93 a company with a mission to transform lives.Our Canadian teamWe know that people living with a rare disease and their families deserve our unwavering commitment and investment into finding and accessing therapies that help them live longer, fuller lives. Our presence in Canada has grown to over 200 employees and includes a global research and development hub, made up of highly skilled professionals responsible for conducting our clinical trials in Canada and around the world, as well as our dedicated and passionate local teams that ensures our treatments reach those who need them. Together, we are driving patient impact locally and globally.How we work
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That\xc3\xa2\xc2\x80\xc2\x99s why we work, on average, a minimum of three days per week from the office. But that doesn\xc3\xa2\xc2\x80\xc2\x99t mean we\xc3\xa2\xc2\x80\xc2\x99re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Alexion embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Alexion is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Alexion Pharmaceuticals