Document Specialist

4 weeks ago

sany, India Randstad India Full time
Responsible for document creationformatting and performing updates in the clients
RIMsystem. The role also involves document routing and tracking thedocuments in the
dossier planner. Directly supportformatting processing and compilation of Word and
PDFdocuments to the appropriate client specifications.
Format and review word documents in preparation for publishing inaccordance with all
relevant client style guides and /or regulatory guidelines and specifications and withinall
established timelines.
Perform documentconversion to PDF and formats and reviews PDF documentsto
specification (for eCTD compliance) includingbookmarks hyperlinks keyword linking
document propertiesetc. in accordance with all relevant client style guides and /or
regulatory guidelines and specifications and withinall established timelines.
Compile regulatory documents/ reports gathering all required documents within all
established timelines. FunctionalResponsibilities
Delivery
Regulatory Component Document Creation and Revisions in RIMSystem:
Component documents are accuratelycreated/updated in the RIM system.
Bookmarks are appliedbefore routing for approval.
Metadata are correctlyentered
Correct template is chosen from the dropdownlists in RIMs.
Documents are routed to reviewers forcomment.
Comments are tracked for resolution using WORDtools.
Formatting is performed using the Authortoolbar.
Regulatory component documentworkflow:
Component documents are routed for workflowand tracked via the Dossier
Planner/tracker or otherappropriate methods per the project leader.
Workflowauthor signature is applied to the document prior to theapprover.
Data Review:
The MS&T portionof CPIFs are accurately and completely populated in the
timeframe requested by the Packaging Engineer
SupportingDocument Processing: JobDescription Upload External Documents to the RIM system to supportthe regulatory
component document approval.
External documents are reviewed for legibility applicabilitycompleteness vs.
the submission plan and regulatorycomponent document prior to routing for
approval.
Send the documents to workflow approving asauthor before obtaining
approval.
Preparedocuments for upload to the RIM tool as applicable:
Documents providing evidence of the application submission orsubmission
approval are prepared according to therequirements of the change control
procedure andprovided to the deliverable owner for upload.Training compliance
Ensure that all trainings(internal training and client training) are successfully
completed in a timely manner by each team memberNote: The above statements describe the general natureand level of work to be performed and
are not anexhaustive list of all responsibilities required for theposition.Education
B. Pharma/BSDegree and/or advanced degree in a health or life science relatedfield
Skills and personal attributes
Extensive experience and technical skills within RegulatoryOperations
Ability to directly oversee and lead projectsand people in a matrix environment
Excellentrelationship building people management and communicationskills
Integrity credibility and commitment to buildingthe CONTINUUM brand in the
marketplace
Demonstrates the ability to use knowledge and experience tounderstand financial and
industry data to makedecisions Minimum WorkExperience
At least 5 years of experience in regulatory publishing activities. If the candidatehas following
experience it would be aplus:

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