PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
POSTS:
- Manager, Document Specialist Group {below}
- PK Analyst
- Consultant Regulatory Affairs
Post: Manager, Document Specialist Group
Job Description:
Essential Function
The Document Specialist Lead owns the document technology process for Medical Writing Services (MWS). Some specific responsibilities include: managing, resourcing and tracking the daily workflow and quality of the groups output; training and supervision of document specialist staff on processes and deliverable requirements; reporting metrics for deliverables; and managing document technology program needs for specific client projects. In addition, the Document Specialist Lead is involved in production work such as compilation of appendices to clinical study reports and similar documents, document scanning/uploading, preparation of electronic appendices using departmental publishing workstation and other document formatting requirements. The Document Specialist Lead 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, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle matters of a confidential nature.
Key Accountabilities
- Own and lead the document technology process for MWS, providing subject matter expertise as required to the department
- Manage and track daily workflow. Ensure adequate resourcing.
- Ensure high quality of deliverables of the document technology group
- Train and supervise document specialist staff on processes and deliverable requirements
- Maintain records of document technology group output, and collect and report on document technology group metrics
- Manage document technology program needs for specific client projects and interface with client and project teams as necessary
- 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-document hyperlinking, 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 document specialist deliverables (own and team) 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.
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Experience:
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
- Experience in leading and managing teams
Education
- Primary degree, either in health-related sciences with significant experience in document processing/publishing, and/or in computer science or technology.
Language Skills
- 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). Experience with processing multiple clinical documents of varying complexity such as clinical trial submission dossiers, clinical study reports, etc., as an independent document technologist or specialist.
Additional Information:
Location: Karnataka - Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 4th Oct, 2012
Req Number: pare-10017760
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Post: PK Analyst
Job Description:
* Mainly supports programming activities within the assigned clinical trial and ensures that all programming activities are executed in a timely manner and to the required high statistical and reporting standards as specified in Standard Operating Procedures (SOPs).
* Programs and documents derived datasets, listings, tables, figures and statistical appendices mainly for safety, pharmacokinetics and pharmacodynamics of clinical studies.
* Ensures that the deliveries match the agreed specifications. Supports quality control and quality audits of deliverables.
* Working according to International Conference on Harmonization Good Clinical Practice standards.
* Maintain a positive, results orientated work environment, building partnerships.
* Other duties as assigned.
* Review of scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports
* To attend client meetings and represent PK/PD aspects as needed
Experience:
A 3 year degree or equivalent, in a programming discipline is preferable; Post graduate qualification is advantageous:
* Good programming skills.
* Windows applications; Word (including adapting and writing macros); E-mail; Excel; Internet; Powerpoint.
* Professional attitude; Self-motivated; Logical thinking; Attention to detail; Client liaison; Able to work independently; First time quality control; Communication of programming issues to non-technical staff.
* Excellent inter-personal, verbal and written communication skills.
* Client and quality focused approach to work.
* A flexible attitude with respect to work assignments and new learning.
* Willingness to work in a matrix environment and to value the importance of teamwork.
* Ability to work well under pressure and to keep scheduled timelines
Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 4th Oct, 2012
Req Number: pare-10021156
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Post: Consultant Regulatory Affairs
Job Description:
* Responsible for the coordination and the preparation and review of documents/packages for regulatory submissions. CTA/MAA
* Develop and execute regulatory strategy for CTA, MAA and maintenance of licences/authorizations according to needs
* Track status and progress of regulatory documentation
* Review of labels
* Monitor applicable regulatory requirements; assure compliance with the companys and external standards
* Compile and prepare responses to regulatory authorities queries
* Maintain regulatory files in a format consistent with requirements
* Establish communication and good working relationships within other functions and the health authorities
* Awareness of regulatory requirements
* Liasoning with DCGI office/customs/Central Drug Labs and other regulatory authorities
* Pre-submission screening for all DCGI submissions.
* Follow-up with external experts for receiving the documents and sending their comments to DCGI
Experience:
4 years of experience in clinical research regulatory affairs and exposure to product registrations
Additional Information:
Location: Haryana - Gurgaon
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 4th Oct, 2012
Req Number: pare-10020958
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