Job Description Document Controller Remote 6 Months Job Description: ROLE SUMMARY The Associate, Document Specialist will assist with non-clinical document management and preparation.
The role helps to manage document upload, creation, and workflows within the clients global electronic document management system (GDMS) and provides specific support to the Regulatory Submission Professionals (RSPs) managing integration/acquisition projects.
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In addition, this individual will help identify and create Master Lists of DSRD specific data and documents (including study reports, SEND files, and regulatory submissions amongst others) for transfer into GDMS and/or other document repositories in partnership with other nonclinical lines, and enabling functions.
Using Document Standards and Requirements, the individual may assist regulatory colleagues prepare documents to a submission-ready format, and provide regular project status updates to the Regulatory Operations Lead.
ROLE RESPONSIBILITIES
– Manages documents and workflows in GDMS, ensures document properties are appropriately set, and uploads documents and data according to internal practices and document standards and requirements.
– Follows the necessary change management processes to maintain compliance during creation of new and revision of existing documents.
– Use of Sharepoint, TEAMS, excel and other systems are to support document management/collaboration and acquisition-related activities.
– Submission-readiness of documents including QC, formatting, linking and managing nonclinical documents using existing practices.
– Interfaces with other parts of the organization such as other non-clinical operations support (in Med Design, Non-Clinical Pharmacology), enabling sunctions (Digital, Records Management) and other supporting functions on site.
BASIC QUALIFICATIONS Bachelors degree in a scientific or business related field, with at least 1 year of experience, preferably in a Biopharmaceutical or other regulated environment.
OR General Education with minimum of 3 years of experience in a similar document specialist role, preferably in a Biopharmaceutical or other regulated environment.
OR Minimum of 5 years of experience in a documentation-related or supporting function is required, preferably in a Biopharmaceutical or other regulated environment.
ESSENTIAL SKILLS REQUIREMENTS
– Experience working within GDMS as uthor and/or content creator
– Proficient using Microsoft applications (inc., outlook, excel, word, TEAMS), fileshare areas (Sharepoint), and Adobe PDF documents.
– Experience proofing, formatting, linking, and QC’ing documents.
PREFERRED EXPERIENCE & TECHNICAL SKILL REQUIREMENTS
– Able to quickly learn and navigate GDMS to facilitate routine document management tasks
– Familiarity managing study documents (protocols & reports) and/or regulatory submission documents (inc., INDs, NDAs, SEND files).
– Some experience or knowledge of submission-ready requirements and preparation of documents for delivery to Health Authorities
– Skilled in word processing and document formatting; experienced in Microsoft Office applications (Word, Excel, PowerPoint, Visio)
– Able to effectively proofread documents prepared by self and others for content and others to ensure content and formatting accuracy
– Demonstrates an ability to adapt to shifting priorities, change, stress and to find appropriate balance between needs of the organization, others and self.
Incorporates insights of other people into ongoing work.
– Able to learn and understand pharmaceutical processes in order to assist with training needs
– Strong organizational and communication skills, detail-oriented
– Team based collaborative problem solving
– Some Project Management experience preferred but not essential