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