Parexel invites for Senior Document Specialist, PK Analyst/Programmer, Senior Auditor, Senior Statistical Programmer, Clinical Data Analyst II, Quality Specialist II
PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.Post:
· Senior Document Specialist {below}
Position: Senior Document Specialist
Job Description:
Essential Function
The Senior Document Specialist will provide advanced document technology support on Medical Writing Services (MWS) projects as appropriate. The SeniorDocument Specialist will be involved in production work such as compilation of appendices to clinical study reports and similar documents, documentscanning/uploading, preparation of electronic appendices using departmental publishing workstation and other document formatting requirements. The SeniorDocument Specialist must be conscientious, able to work and lead teams with minimal supervision, have an aptitude for working with a variety of different software applications and systems, exhibit a high degree of flexibility and initiative, and demonstrate the ability to follow up on multiple tasks.
Essential Function
The Senior Document Specialist will provide advanced document technology support on Medical Writing Services (MWS) projects as appropriate. The SeniorDocument Specialist will be involved in production work such as compilation of appendices to clinical study reports and similar documents, documentscanning/uploading, preparation of electronic appendices using departmental publishing workstation and other document formatting requirements. The SeniorDocument Specialist must be conscientious, able to work and lead teams with minimal supervision, have an aptitude for working with a variety of different software applications and systems, exhibit a high degree of flexibility and initiative, and demonstrate the ability to follow up on multiple tasks.
Relationships
Reports To Departmental Line Management, MWS
Directly Supervises None
Provides Work Direction to Document Specialists
Works Closely with Medical Writers, Clinical and Project Leadership staff
External Relationships Client technical representatives
Reports To Departmental Line Management, MWS
Directly Supervises None
Provides Work Direction to Document Specialists
Works Closely with Medical Writers, Clinical and Project Leadership staff
External Relationships Client technical representatives
Key Accountabilities
* Independently compile appendices to clinical study reports in compliance with appropriate regulatory requirements. Work with internal or external Clinical and/or Project Leadership functions to ensure that appendix documentation is complete and complies with the relevant guidelines.
* Perform scanning and uploading of paper documents
* Be responsible for conversion of documents to PDF format
* Use departmental publishing software to produce electronic deliverables to ensure insertion of navigability features, and accurate intra-documenthyperlinking, according to SOP/client/regulatory requirements
* Perform MS Word formatting of clinical documents according to SOP/client/regulatory requirements. Insert tables if requested
* Organize and track delivery of appendices, and any other documents as required
* Ensure all deliverables are complete and of high quality prior to distribution to both internal and external clients
* Work with IT and Validation groups to ensure maintenance of software and hardware owned by MWS, including tracking and validation of software updates. Perform the Designated Responsible Individual (DRI) role for MWS software, if requested.
* Train and mentor junior members of the team on processes and deliverable requirements, as required
* Provide subject matter expertise to MWS management, Medical Writers and other Document Specialists, when required
* Support MWS management in collection and reporting of metrics and other departmental tasks as appropriate
* Independently compile appendices to clinical study reports in compliance with appropriate regulatory requirements. Work with internal or external Clinical and/or Project Leadership functions to ensure that appendix documentation is complete and complies with the relevant guidelines.
* Perform scanning and uploading of paper documents
* Be responsible for conversion of documents to PDF format
* Use departmental publishing software to produce electronic deliverables to ensure insertion of navigability features, and accurate intra-documenthyperlinking, according to SOP/client/regulatory requirements
* Perform MS Word formatting of clinical documents according to SOP/client/regulatory requirements. Insert tables if requested
* Organize and track delivery of appendices, and any other documents as required
* Ensure all deliverables are complete and of high quality prior to distribution to both internal and external clients
* Work with IT and Validation groups to ensure maintenance of software and hardware owned by MWS, including tracking and validation of software updates. Perform the Designated Responsible Individual (DRI) role for MWS software, if requested.
* Train and mentor junior members of the team on processes and deliverable requirements, as required
* Provide subject matter expertise to MWS management, Medical Writers and other Document Specialists, when required
* Support MWS management in collection and reporting of metrics and other departmental tasks as appropriate
Skills
* Excellent interpersonal, verbal and written communication skills, and good degree of initiative
* Client focused approach to work
* Flexible attitude with respect to work assignments and new learning
* Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail
* Ability to work in a matrix environment and to value the importance of teamwork, connecting with a broad range of cultures
* Advanced word processing skills in MS Word/Office. Ability to apply formatting to template documents, perform quality checks, edit tables and figures within templates, and verify template data against source documents.
* Advanced PDF processing skills in Adobe Acrobat
* Advanced skills in other document editing software, such as design and application of styles/templates, graphics, and integration with other applications
* Proficient in document management systems and key publishing software. Experience with advanced tools for publishing such as ISI Toolbox, Core Dossier, and related plug-ins, is an advantage.
* Experience in working on clinical submission documents, clinical study reports, protocols, appendices, etc., and assembly of electronic submissions in compliance with technical editorial and format requirements
* Proficiency in basic grammar, punctuation, and spelling. Understanding of medical and pharmaceutical terminology desired.
* Advanced keyboard skills
* Excellent interpersonal, verbal and written communication skills, and good degree of initiative
* Client focused approach to work
* Flexible attitude with respect to work assignments and new learning
* Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail
* Ability to work in a matrix environment and to value the importance of teamwork, connecting with a broad range of cultures
* Advanced word processing skills in MS Word/Office. Ability to apply formatting to template documents, perform quality checks, edit tables and figures within templates, and verify template data against source documents.
* Advanced PDF processing skills in Adobe Acrobat
* Advanced skills in other document editing software, such as design and application of styles/templates, graphics, and integration with other applications
* Proficient in document management systems and key publishing software. Experience with advanced tools for publishing such as ISI Toolbox, Core Dossier, and related plug-ins, is an advantage.
* Experience in working on clinical submission documents, clinical study reports, protocols, appendices, etc., and assembly of electronic submissions in compliance with technical editorial and format requirements
* Proficiency in basic grammar, punctuation, and spelling. Understanding of medical and pharmaceutical terminology desired.
* Advanced keyboard skills
Education
* Primary degree, either in health-related sciences with significant experience indocument processing/publishing, and/or in computer science or technology.
* Primary degree, either in health-related sciences with significant experience indocument processing/publishing, and/or in computer science or technology.
Language Skills
* Fluent in written and spoken English.
* Fluent in written and spoken English.
Minimum Work Experience
* Good knowledge of word processing and publishing software with proven ability (15-17 pages per hour of formatting and post PDF work). Extensive experience with processing multiple clinical documents of varying complexity such as clinical trial submission dossiers, clinical study reports, etc., as an independent documenttechnologist or specialist.
* Good knowledge of word processing and publishing software with proven ability (15-17 pages per hour of formatting and post PDF work). Extensive experience with processing multiple clinical documents of varying complexity such as clinical trial submission dossiers, clinical study reports, etc., as an independent documenttechnologist or specialist.
Additional Information:
Location: Karnataka - Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 3rd Feb, 2012
Req Number: pare-10024227
Location: Karnataka - Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 3rd Feb, 2012
Req Number: pare-10024227
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