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Role Summary

The Regional Dossier Publisher (RDP) will work within the MSD Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations Asia Pacific (RAO-AP) department in Singapore. The RDP is responsible for publishing key regulatory submissions in the region and supporting the publishing work carried out by our decentralised publishing team who are working on dossiers for the region. The RDP will have a good knowledge of the regulatory procedures and requirements in the region and be able to apply this to the publishing processes and tools to ensure that the submissions delivered to the Country RA groups meet their specific needs.

The RDP will also be involved with supporting Country RA teams with their local publishing and submission transmission needs and ensure they can meet their submission deadlines. The RDP will also work with colleagues from the Head Quarters publishing functions to assist in the development of the tools and procedures that support our submission planning and publishing procedures.

Key Responsibilities

• The RDP will be responsible for identifying and maintaining requirements supporting regulatory dossier assembly (aka publishing) and delivery to regulatory health authorities or to the country organization in the region.
• The publisher will support the maintenance of related processes in accordance with regional/country requirements, and also will support the central publishing team responsible for executing the assembly processes to generate regional/country compliant to regulatory requirements.
• The publisher will execute the assembly and delivery processes, in particular to meet critical submission targets. The RDP will be the regional expert for regulatory submission capabilities, including dossier structures and file formats, electronic submissions and transmission (e.g. agency gateways), dossier repositories and databases.
• He/she will play an advocating role for standardization across the supported countries within the region.
• Maintain the regional/country regulatory dossier assembly requirements (structure, organization, formats: paper and electronic, delivery methods, etc.)
• Lead technical impact assessments of regional/country requirements for regulatory submissions.
• Serve as the technical expert for local Country RA teams.
• Provide training to the Country RA teams on the publishing processes.
• Support the maintenance of processes and systems related to the assembly and delivery of regulatory submissions.
• Ensure readiness of the assembly and delivery related systems and toolsets for the region (publishing system, validation tools, media creation (e.g. CD, DVD). Participate in system testing, performance measures and other efforts necessary for readiness.
• Support the Central Publishing Team in understanding and applying the regional/local regulatory dossiers requirements.
• Develop and provided necessary training and communication.
• Execute the assembly and delivery process, when necessary, to meet submission targets.
• Serve as the technical expert and point of contact for health/regulatory authorities in the region.
• Support the technical validation process. Support the region adopting global or established standards in the regulatory submissions area.

Qualifications

Qualification

• Degree in Life Sciences or IT with pharmaceutical industry experience.
• Minimum 5 years publishing experience with Liquent Insight Publisher, knowledge of other publishing tools will be considered as a plus.
• Strong analytical and customer service skills with the ability to work with varying grade levels, educational background and departments.
• Excellent interpersonal skills and oral and written communication skills.
• Demonstrated ability to work under tight deadlines.
• Proven attention to detail and ability to work with a variety of technical applications.
• Strong knowledge of the English language.
• Working knowledge of the standard computer applications (MS Office applications, Adobe Acrobat, MS Project, Documentum)
• Knowledge of publishing requirements in the Asia Pacific region.
• Knowledge of the regulatory registration procedures in the Asia Pacific region will be considered as a plus.