• This role offers an excellent opportunity for professional growth
• Joining this company will allow you to contribute to impactful project

Sobre o nosso cliente

Our client is a global healthcare company committed to improving access to high-quality medicines and healthcare solutions worldwide. The Senior Publishing Specialist will be responsible for supporting the end-to-end publishing and submission of regulatory dossiers for new and existing products in electronic format to meet company standards, agency requirements and defined timelines. This includes quality control, validation, electronic transmission, and archiving of submissions. Utilise specialised publishing, document management and RIM tools as appropriate. Troubleshoot technical issues, manage submission schedules, and serve as a subject matter expert for publishing activities. Contribute to process improvements, system support, and regulatory project work, while also mentoring junior colleagues and providing leadership support as needed.

Descrição

• Publish Marketing (MA) Applications and maintenance submissions in eCTD or non-eCTD formats, as appropriate, for both new and existing products, including Emerging and Rest of World markets;
• Ensure all publishing requests are processed in a timely manner to meet internal and Health Authority deadlines and Service Level Agreements;
• Perform QC and technical validation of electronic submissions to ensure compliance with internal standards and external criteria before delivery to Regulatory Affairs and other disciplines as applicable for internal review/approval;
• Perform electronic transmission of submissions to Health Authorities as requested or provide finalised submission to country offices for local dispatch to Health Authorities;
• Archive submissions within the agreed timelines to ensure effective sharing with all internal stakeholders;
• Troubleshoot and resolve technical validation issues identified by regulatory agencies or during internal checks;
• Manage and monitor publishing schedules, coordinate global support during resource constraints, and provide workload and project summaries at team meetings or to leadership;
• Serve as the primary contact and Subject Matter Expert (SME) for publishing queries across Regulatory Affairs and cross-functional disciplines;
• Develop and maintain subject matter expertise in a designated area, act as the primary contact for related queries, and present updates on projects at team meetings;
• Attend and actively contribute to all Team and one-to-one meetings, including hosting Team Meetings on a rota basis, collating agenda items and preparing minutes;
• Document and share all learnings with the global Publishing team for the benefit of all regional teams;
• Develop high-quality working relationships and display social and business maturity when interacting with colleagues.

Perfil ideal

• Academic qualification and a minimum of 5 years of professional experience. However, an equivalent combination of experience and/or education will also be considered;
• Experience with eCTD publishing tools (Lorenz docuBridge is preferred) and Document Management Systems (D2 and Veeva are preferred);
• Ability to manage and plan workload under competing priorities and tight timelines;
• Ability to work in a fast paced, highly cross functional team environment;
• Must maintain a strong knowledge of eCTD requirements for multiple Health Authorities;
• Ability to read and interpret complex business and/or technical documents;
• Strong organization skills and attention to detail.

Vantagens

The company offers a competitive compensation and benefits package, as well as the opportunity to work in a collaborative, international, and cross-functional environment that values diversity, inclusion, and professional growth.