Clinical Project Manager - Publishing
The Clinical Publishing Project Manager will manage activities associated with generating clinical regulatory submissions, including identifying and sourcing planned submission content, managing and planning submission timelines and projects, overseeing publication activities, resolving publishing and submission issues, applying quality control processes, document management, and engage in life cycle management of clinical submission documents to ensure document integrity, and utilizing a wide array of document management, tracking, publishing, and eCTD building tools.
Duties &Responsibilities Overview:
This position will be responsible for the coordination of publishing tasks associated with the assigned submission, including initial quality control of submissions generated by other Global Publishers and eCTD Administrative tasks. This position will work in close collaboration with the Global Publishers, Publishing Managers, including regularly providing up to date status reports and reporting of issues in a timely manner.
Manage and ensure all clinical documents are published according to regulatory requirements and existing clinical publishing processes.
Help gather and track publishing and/or submission metrics.
Manage generation and compilation of module 5 eCTD clinical sections of submissions using electronic document and publishing technology.
Apply quality control processes, document management, and engage in life cycle management of clinical submission documents to ensure document integrity.
This position will support all IND/marketing application submission types. This will ensure proper cross-training and support of submission timelines.
Manage all aspects of marketing application and IND type submissions in order to provide a fully navigable, reviewable and compliant submission, ensuring a high quality dossier to the agency.
Provide support to global publishing team in managing publishing tasks associated with the compilation of European submission activities on an as-needed basis to ensure support of European colleagues to provide a fully navigable, reviewable and compliant submission ensuring a high quality dossier to the agency.
Work closely with the Dossier Publishing Manager to maintain understanding of the current workload, capability of ensuring the timely finalization of all submissions, and to provide quality control support to other Publishers.
Assist with the training of submission activities to all levels of publishing staff.
Act as lead publisher for all US marketed applications. Act as lead publishing contact for marketed applications. Provide first line support to Dossier Publishing Manager with regards to publishing.
Assist with training and support to the Dossier Leads & Submission Managers. They will have the ability to represent the US publishing group in meetings and initiatives associated with eCTD, publishing tool validation and industry meetings.
6-9 years experience in a related industry or academic field or equivalent.
Familiarity with content and organization of regulatory submissions required.
Thorough knowledge of U.S. FDA Regulations and ICH Guidance’s as they apply to the creation of investigational drug (IND) and marketing applications.
Knowledge of eCTD submission format.
Demonstrated ability to work in a technical environment required.
Minimum four years experience in Regulatory Affairs or equivalent.
Minimum BA/BS degree in the Lead publisher experience, preferably in a health-related field, or equivalent theoretical/technical experience.