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 QA check for the published document. Will also be responsible for renewal and continuation of marketing licenses of the drug, Coordination with multiple stakeholders to report adverse events.
- 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 under minimal 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
- 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 under minimal 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 under minimal supervision
- Perform occasional report publishing in collaboration with authors across functions
- Ensure overall submission quality
- 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
- Communicate and advise product teams / individuals on RSG publishing requirements
- Mentor / train Junior 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
· 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
· 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 of 2 to 5 years relevant experience in the pharmaceutical industry
· Regulatory publishing experience
Why should you join us?
- Opportunity to work with one of the Top 10 Pharma company partner.
- Looking for candidates from Medical, Pharma & Science Field.
- Opportunity to work and learn Pharmacovigilance – Drug Safety(The branch of pharmacology focused on detecting, assessing, understanding and preventing long- and short-term adverse effects of medicines.) and its regulations
- Options to work Part/Full Time.
- Also you can work from home.