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Job Details

Submission Publisher

Company name
Tata Consultancy Services Limited

Sharonville, OH

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Job Description
TATA Consultancy Services  is looking for a dynamic Submission Publisher who is interested in working in the fast-faced BioPharmaceuticals industry.   The Submission Publisher will work on creating navigation in PDF documents from Clinical study reports, CRF processing, word formatting and publishing of eCTD, NeeS and Papers.  The ideal candidate will have 2-5 years of experience and the following:\r\rRequirements: \r\r Experience with mainstream publishing tools (e.g. Insight publisher or equivalent)\r Broad technical knowledge  (MS Word, Adobe Acrobat, Acrobat Plug-ins, Document Management Systems, Excel)\r Experience in eCTD publishing for low/medium complexity in one or more ICH and  global eCTD filing.\r Experience in an operationally focused role\r Reviewing the publishing request and processing as per provided comments and regulatory requirements\r Compliance checks of provided document (M2, M3, Clinical, Non-clinical and other document)\r Formatting of Regulatory document includes – Module 1 to Module 5 documents\r Processing PDF document using publishing plug-ins (Smartdesk/ISI tool box or any other tool\r Prepare submission planner as per submission type for US, EU and ROW market\r Preparing, compiling and publishing eCTD submission based on client requirements\r Performing external hyper linking task for the published output document and validation of the submission\r\r

Job Requirements
Qualifications:  \r\r Master’s degree in Pharmacy, Medical and/or Life Science OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree & 4 years of directly related experience OR High school diploma / GED & 6 years of directly related experience OR Master’s degree in Pharmacy, Medical and/or Life Science\r Working knowledge of global regulatory practices, electronic submission guidelines and requirements.\r Must exhibit strong attention to detail, have good organization, communication, and collaboration skills, and seamless multi-tasking abilities to be able to work simultaneously on multiple projects. \r Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, Lync, Access, Documentum, InSight Publisher, InSight Validator eCTD viewers and web based applications) and be technically savvy with such systems.\r Ability to work a flexible schedule per project requirements. \r The ideal candidate will work out of the TCS office location in Cincinnati, OH, however, candidates who are interested in working remotely can be considered with proper credentials. \r

Company info

Tata Consultancy Services Limited
Website :

Company Profile
Tata Consultancy Services (TCS) is one of the world s leading information technology companies. Through its Global Network Delivery Model „ , Innovation Network, and Solution Accelerators, TCS focuses on helping global organizations address their business challenges effectively. TCS continues to invest in new technologies, processes, and people which can help its customers succeed. From generating novel concepts through TCS Innovation Labs and academic alliances, to drawing on the expertise of key partners, it keeps clients operating at the very edge of technological possibility. Whether TCS is envisioning a business advantage, engineering an IT solution, or executing an outsourcing strategy, it helps its customers experience certainty in their every day business. TCS reported 2006-07 global revenues of USD 4.3 billion.

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