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Regional Dossier Publisher, Regulatory Operations, Brussels Job

Date: Nov 12, 2017

Location: Brussels, BE

Company: MSD

Requisition ID: REG003055

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.

MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. MRL is a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

We have an exciting opportunity for a Regional Dossier Publisher, Regulatory Affairs, to join our Regulatory Operations teams in Brussels, Belgium.

• The Regional Dossier Publisher (RDP) will work within the MSD Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations Europe, Middle-East and Africa (RAO-EMEA) department in Europe (Brussels, Belgium).

Main 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.


Education Requirements:
• Bachelors Degree in Life Sciences or IT with pharmaceutical industry experience.

Required Experience and Skills:
• Minimum 3 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 Europe.
• Knowledge of the regulatory registration procedure in Europe will be considered as a plus.

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

Recruitment Agency / Search Firm representatives please note:
MSD will not accept unsolicited CVs from recruitment agencies / search firms under any circumstances. In order to present CVs to MSD, your Recruitment Agency / Search Firm will have been invited to work on a specific vacancy and have Terms of Business signed and agreed with the relevant Recruitment and Staffing Regional Lead. Should you send CVs for a vacancy that you have not been specifically invited to work on to any employee at MSD (via email, post, internet, Taleo or any other method), these will be deemed the sole property of MSD. MSD will pay no introduction fee to the Recruitment Agency / Search Firm if a candidate is hired as a result of an agency introduction under these circumstances.

Job: Regulatory Affairs Generic
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Employee Status: Regular
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Company Trade Name: MSD

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