Requisition ID: REG004549

MSD is a global health care leader with a diversified

portfolio of prescription medicines, vaccines and animal health products. The

difference between potential and achievement lies in the spark that fuels

innovation and inventiveness; this is the space where MSD has codified its

125-year legacy. MSD’s success is backed by ethical integrity, forward

momentum, and an inspiring mission to achieve new milestones in global

healthcare.

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.

Job: Regulatory Affairs Generic

Other Locations:

Employee Status: Regular

Travel:

Number of Openings: 1

Shift (if applicable):

Hazardous Materials:

Company Trade Name: MSD