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Senior Publishing Specialist

Function

1. 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
  • Regularly represent PDRO at RAFT by providing regulatory and technical input and contributing in project planning; Update PDRO on changes of strategies, timelines and risk assessment


2. 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)
  • Liaise with regulatory product managers, concerned functions and external Business Partners organizations when applicable; facilitate communication and collaboration to meet submission timelines and plan future work without supervision
  • Perform occasional report publishing in collaboration with authors across functions
  • Ensure overall submission quality

3. Coordination of EU Product Information Annexes (EU Specific)

  • Coordinate EU Annexes translations with Product Managers, EU Affiliates and other functions and ensure adherence to EMEA/QRD requirements:
  • 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

4. PDR Support

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

5. Training and process support

  • Mentor / train Junior Publishing Specialists and Publishing Specialists in publishing processes and standards and conduct group training sessions when necessary.
  • 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
  • Write / update submission guidelines and SOPs, as well as conduct user training
  • Provide input on future systems enhancements, development requirements and support UAT testing as required
  • Assist technical teams to develop, validate and implement electronic processes and procedures

Requirements

· Degrees: Bachelor’s Degree in Life Sciences

· Excellent oral and written communication skills in English

· Excellent attention to details

· Good computing skills – extensive experience in MS Word, Excel, eCTD requirement, lifecycle management, Adobe Acrobat & ISI Toolbox and Compose

· Advanced 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

· Able to handle multiple project assignments

· Ability to work under minimal supervision

· Ability to work with changing, sometimes high workload

· Minimum 5 years relevant experience in the pharmaceutical industry

Information

At TCS you will discover:

  • A colorful and dynamic work environment with a great diversity of people, cultures and business areas
  • An open culture that improves the quality of life
  • Learning and sharing that helps you to progress both professionally and personally