PAREXEL International

JOB DESCRIPTION
Job Title Sr.Document Specialist
Department Medical Writing Services
Essential Function
The Document Specialist Lead owns the document technology process for Medical Writing Services
(MWS). Some specific responsibilities include managing! resourcing and trac"ing the daily wor"flow
and #uality of the group$s output% training and supervision of document specialist staff on processes
and deliverable re#uirements% reporting metrics for deliverables% and managing document technology
program needs for specific client pro&ects. 'n addition! the Document Specialist Lead is involved in
production wor" such as compilation of appendices to clinical study reports and similar documents!
document scanning(uploading! preparation of electronic appendices using departmental publishing
wor"station and other document formatting re#uirements. The Document Specialist Lead must be
conscientious! able to wor" and lead teams with minimal supervision! have an aptitude for wor"ing
with a variety of different software applications and systems! e)hibit a high degree of fle)ibility and
initiative! demonstrate the ability to follow up on multiple tas"s and pro&ects! and possess the ability to
handle matters of a confidential nature.
e! Accountabilities
*wn and lead the document technology process for MWS! providing sub&ect matter e)pertise as
re#uired to the department
Manage and trac" daily wor"flow. +nsure ade#uate resourcing.
+nsure high #uality of deliverables of the document technology group
Train and supervise document specialist staff on processes and deliverable re#uirements
Maintain records of document technology group output! and collect and report on document
technology group metrics
Manage document technology program needs for specific client pro&ects and interface with
client and pro&ect teams as necessary
,ompile appendices to clinical study reports in compliance with appropriate regulatory
re#uirements. Wor" with internal or e)ternal ,linical and(or -ro&ect Leadership functions to
ensure that appendi) documentation is complete and complies with the relevant guidelines.
-erform scanning and uploading of paper documents
.e responsible for conversion of documents to -D/ format
0se departmental publishing software to produce electronic deliverables to ensure insertion of
navigability features! and accurate intra1document hyperlin"ing! according to
S*-(client(regulatory re#uirements
-erform MS Word formatting of clinical documents according to S*-(client(regulatory
re#uirements. 'nsert tables if re#uested.
PAREXEL International
*rgani2e and trac" delivery of appendices! and any other documents as re#uired
+nsure all document specialist deliverables (own and team) are complete and of high #uality
prior to distribution to both internal and e)ternal clients
Wor" with 'T and 3alidation groups to ensure maintenance of software and hardware owned by
MWS! including trac"ing and validation of software updates. -erform the Designated
4esponsible 'ndividual (D4') role for MWS software! if re#uested.
S"ills
+)cellent interpersonal! verbal and written communication s"ills! and good degree of initiative
,lient focused approach to wor"
/le)ible attitude with respect to wor" assignments and new learning
5bility to manage multiple and varied tas"s with enthusiasm! and prioriti2e wor"load with
attention to detail
5bility to wor" in a matri) environment and to value the importance of teamwor"! connecting
with a broad range of cultures
5dvanced word processing s"ills in MS Word(*ffice. 5bility to apply formatting to template
documents! perform #uality chec"s! edit tables and figures within templates! and verify template
data against source documents.
5dvanced -D/ processing s"ills in 5dobe 5crobat
5dvanced s"ills in other document editing software! such as design and application of
styles(templates! graphics! and integration with other applications
-roficient in document management systems and "ey publishing software. +)perience with
advanced tools for publishing such as 'S' Toolbo)! ,ore Dossier! and related plug1ins! is an
advantage.
+)perience in wor"ing on clinical submission documents! clinical study reports! protocols!
appendices! etc.! and assembly of electronic submissions in compliance with technical editorial
and format re#uirements
-roficiency in basic grammar! punctuation! and spelling. 0nderstanding of medical and
pharmaceutical terminology desired.
5dvanced "eyboard s"ills
+)perience in leading and managing teams
E#ucation
-rimary degree! either in health1related sciences with significant e)perience in document
processing(publishing! and(or in computer science or technology.
Lan$ua$e S"ills
/luent in written and spo"en +nglish.
PAREXEL International
%inimum &or" E'perience
6ood "nowledge of word processing and publishing software with proven ability (78179 pages per
hour of formatting and post -D/ wor"). +)perience with processing multiple clinical documents
of varying comple)ity such as clinical trial submission dossiers! clinical study reports! etc.! as an
independent document technologist or specialist.