Ref #: 29544

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 14-Sep-2021



Collaborates closely with the Document Publishing Lead to manage assigned documents and ensure delivery by expected due dates. Knowledgeable in all aspects of submission-readiness
requirements and department processes. Monitors the work request system for new requests and performs assigned tasks with high quality.

•The Document Specialist supports the technical aspects of the Clinical report-level document production for the authoring community. Familiarity with Clinical Study Reports, Protocols, Investigator Brochures, Briefing Documents, and Response Documents is helpful. The individual must communicate closely with the authoring community and other departments.

•Responsibilities include, but are not limited to the technical preparation of submission documents (individual documents and compound documents). Meets internal document standards with regard to formatting, timeliness, and submission readiness, with some direct guidance.

•Provides advanced publishing services of complex documents using industry standard publishing tools, including submission ready formatting, hyper-linking, and bookmarking.

•Provides document management services including electronic document secure storage in the submissions document repository, indexing and archiving of approved documents in accordance with quality standards.

Qualifications required:

Knowledge of publishing software (InSight Publisher knowledge preferred), electronic document management systems, and intra- and inter-document linking. Strong word-processing skills and advanced proficiency with MS Office, Adobe Acrobat Professional, and ISI Toolbox. Knowledge of templates and complex document formats.

• In-depth understanding of the document-level processes, and guidances that impact those processes.

Effective interpersonal, teamwork, and communication skills. Share a sense of urgency for meeting document/submission deadlines.

• Ability to work or lead in a matrix environment and influence stakeholders.

• Knowledge of Regulatory Information Systems, planning, publishing tools, project management, and tracking tools.

• Knowledge and skills to build productive relationships across the organization and with external stakeholders.

• Demonstrated problem solving, troubleshooting, and adaptability.

• Proficiency in submission related HA and Industry regulations and guidelines, as relevant.

• Performs technical QC.

For more information please contact

Please note you must already reside in the UK with the right to work in the UK without sponsorship.