Publishing Manager, Global Regulatory Operations

at  Alexion PharmaceuticalsInc

POSITION SUMMARY

The 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 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.

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 drive
• Very 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 desired
• In-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 preferred

EDUCATION:

• A minimum of a Bachelor’s 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 experience

• 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;
• Ensures the final submitted documents are physically (paper) and electronically archived;
• Develops, reviews, maintains and disseminates publishing Service Level Agreements (SLAs) for different submission categories for efficient planning and resource management;
• Monitors the development of new regulatory requirements or guidance’s and provides advice to Global Regulatory Operations and product teams of the impact on the business;
• Contributes to development and implementation of standards for dossier management, publishing, archiving and submission process for global regulatory authorities;
• Participates in selection and implementation of electronic Regulatory Document Management systems;
• Participates in compliant and timely archiving of regulatory submissions and correspondences for Alexion products;
• Assists the Submission Operations Lead in assessing impact of standards and requirements with a regional impact to existing and new systems;
• Works with GRO leadership to be responsible for strategic implementation of outsourcing services, when needed;
• Ensures SOP adherence, application of standard processes, oversight of contractors and CROs, and customer/team member interactions, and overall vendor management activities;
• Participates 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.