Document Specialist

Responsible for document creation formatting and performing updates in the clients
RIM system. The role also involves document routing and tracking the documents in the
dossier planner. Directly support formatting processing and compilation of Word and
PDF documents to the appropriate client specifications.
Format and review word documents in preparation for publishing in accordance with all
relevant client style guides and / or regulatory guidelines and specifications and within all
established timelines.
Perform document conversion to PDF and formats and reviews PDF documents to
specification (for eCTD compliance) including bookmarks hyperlinks keyword linking
document properties etc. in accordance with all relevant client style guides and / or
regulatory guidelines and specifications and within all established timelines.
Compile regulatory documents / reports gathering all required documents within all
established timelines.

Functional Responsibilities
Delivery
Regulatory Component Document Creation and Revisions in RIM System:
Component documents are accurately created/updated in the RIM system.
Bookmarks are applied before routing for approval.
Metadata are correctly entered
Correct template is chosen from the dropdown lists in RIMs.
Documents are routed to reviewers for comment.
Comments are tracked for resolution using WORD tools.
Formatting is performed using the Author toolbar.
Regulatory component document workflow:
Component documents are routed for workflow and tracked via the Dossier
Planner/tracker or other appropriate methods per the project leader.
Workflow author signature is applied to the document prior to the approver.
Data Review:
The MS&T portion of CPIFs are accurately and completely populated in the
timeframe requested by the Packaging Engineer
Supporting Document Processing:

Upload External Documents to the RIM system to support the regulatory
component document approval.
External documents are reviewed for legibility applicability completeness vs.
the submission plan and regulatory component document prior to routing for
approval.
Send the documents to workflow approving as author before obtaining
approval.
Prepare documents for upload to the RIM tool as applicable:
Documents providing evidence of the application submission or submission
approval are prepared according to the requirements of the change control
procedure and provided 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 member

Note: The above statements describe the general nature and level of work to be performed and
are not an exhaustive list of all responsibilities required for the position.

Education
B. Pharma/BS Degree and/or advanced degree in a health or life science related field
Skills and personal attributes
Extensive experience and technical skills within Regulatory Operations
Ability to directly oversee and lead projects and people in a matrix environment
Excellent relationship building people management and communication skills
Integrity credibility and commitment to building the CONTINUUM brand in the
marketplace
Demonstrates the ability to use knowledge and experience to understand financial and
industry data to make decisions

Minimum Work Experience
At least 5 years of experience in regulatory publishing activities. If the candidate has following
experience it would be a plus: