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Junior Publishing Specialist

Introduction

Publishing Associate will support authors to publish submission ready documents by applying appropriate compliance check to the type of document, publishing the document & also performing the QC check for the published documents. Associate will also be responsible for renewals, continuation of marketing licenses of the drug and coordination with multiple stakeholders to report adverse events.

Function

Primary Responsibilities:

· Support and provide coordination, compilation and publishing expertise in the preparation of new and existing regulatory applications including initial applications (CTAs, MAAs etc.), amendments, supplements, variations and other submissions in compliance with health authority regulations

· Primary focus is on regulatory submissions of moderate to high complexity both eCTD and non-eCTD format, including all Modules accountability for large submissions without supervision

Submission coordination and publishing tasks:

· Lead and coordinate the compilation of paper submissions and assembly of electronic submissions in eCTD including tracking progress of document delivery, gathering metrics for submission processing, quality assurance, releasing and archiving in accordance with SOPs and guidance documents without supervision

· Perform publishing activities using various electronic technologies including electronic publishing (e.g. eCTD, InSight Publisher) and electronic Document Management (IDM)

· Ensure documents are compliant with Client standards and ICH guidelines. Bookmark and hyperlink PDF documents to ensure adherence to ICH guidelines for incorporation into eCTD submissions using PDF editing tools including Adobe Acrobat and ISI Toolbox

· Compilation of electronic submissions in eCTD format for Basic and International license renewals and submit it to the Health authorities without supervision

· Publishing and submission activities for TRICs submissions (Technical Regulatory information change)

· Ensure overall submission quality


Coordination of EU Product Information Annexes (EU Specific)

· Provide support in the preparation of the English Annexes, initiate & coordinate translation activities

· Liaise between the Product management teams and the worldwide pharmaceutical Affiliates to get relevant questionnaires completed

PDR Support

· Communicate and advise product teams / individuals on RSG publishing requirements

Training and process support

· Assist in assuring adherence to current publishing processes and standards and support development of new publishing standards and processes

· Contribute to the improvement of submission processes and working practices through working groups, submission debrief meetings


Requirements

You are the perfect candidate if you have:

Education

Required:

· Degrees: Bachelor’s Degree in Life Sciences

Skills & Qualifications

Required:

· Excellent oral and written communication skills in English

· Excellent attention to details

· IT skills – Very good command of Microsoft Office and Adobe Acrobat

Advantage:

· Regulatory publishing experience

· Working knowledge of document management and publishing software and supporting tools

· Regulatory Knowledge – working knowledge of ICH, FDA, EU dossier structural requirements

Offer

We offer a colorful and dynamic work environment with:

· a great diversity of people, cultures and business areas

· language courses and trainings

· internal rotations

· on-site relax & gym rooms

volunteering, sport and employee events.

Information

Maria Liszkai +36 30 165 86 01

Application

Maria Liszkai +36 30 165 86 01