Publishing and Submissions System Manager

Key People

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

Western Europe,--Basel,Basel,

Key Skills :

regulatory affairs, regulatory, insight publisher, publisher, publishing

Salary :

€76 - €87 per hour

Date Posted :

17 Jan, 2019

Company Name :

Key People

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



The Publishing and Submissions System Manager will be responsible for participating as an active member in cross-functional business teams that support the identification, development, delivery and maintenance of technology projects and systems within Global Pharma Development Regulatory (PDR).

The Publishing and Submissions System Manager will be responsible for supporting Publishing and Submission business users in providing system expertise on a global level, and partner with PD IT in the technical support of Submission tools.

Job Duties/Responsibilities:
* Local and global System Support for Systems Users: Serves as a publishing and submissions system expert to support PD Regulatory on the system usage and processes
* Serves as primary contact and local expert for all publishing and submissions systems, including Insight Publisher, Insight for Viewing and issues as a first level of support and liaison between PD Regulatory and PD IT
* Lead user requirements collection and management, prioritization of system enhancements
* Ensure risks have appropriate mitigation and contingency plans
* Participate in publishing and submission systems user forums
* Supports Regulatory users in the development of applicable systems development process steps and documentation requirements
* Represents PDRZ (Regulatory Technology) as Publishing and Submissions SME in initiatives and system upgrade projects
* Attends and contributes in Publishing and Submission support team meetings
* Supports successful implementation of systems by providing business process knowledge, system knowledge, and best practice
* Provides SME level assistance for the resolution of support tickets
* Partners with PD IT to implement effective system solutions, user access management, and change control
* Collaborates with internal training groups, PD IT and external vendors to provide input in the creation of standard training materials
* Coordinate and participate in system User Acceptance Testing (UAT) as needed

Experience Required:
* Demonstrated experience in working with publishing and submission tools
* Experience working with Insight Publisher and the Liquent suite of tools
* Demonstrated proficiency in using, troubleshooting, supporting and training information systems
* Proven ability to obtain results in a global, cross-site matrix environment including customer service skills and stakeholder management
* Demonstrated ability to execute on a technology strategy and ensure that results are in alignment to the business' priorities
* Ability to communicate, present and train across a variety of audiences, including business people and technologists (both up and down the organization)
* Regulatory knowledge with regards to submission generation and related technology is a must
* General understanding of various System Development Life Cycles (SDLCs) and system integrations * Demonstrated competency in planning, tracking and delivering on assignments and requests
* Ability to work cross functionally, across global locations/time zones
* Proven ability to create strong working relationships in a global setting with many different cultures
* Excellent listening, problem solving, and facilitation skills
* Excellent verbal and written communication and presentation skills Education

* Relevant Bachelor's degree in MIS, Life Sciences, Business; or equivalent experience
* 5+ years of experience as a successful systems leader in the field of IT systems and business processes within pharmaceutical Industry.
* Regulatory and system compliance
* Impeccable ethics. Demonstrates, or has proven abilities to demonstrate
* Contributes to a motivating, elevating and inspiring environment
* Proven expertise in effectively and efficiently managing multiple operational activities on an ongoing basis
* Excellent written and oral communication skills
* Enthusiastic orientation to teamwork: works collaboratively, effectively and efficiently with others internally and externally
* Some travel required

For further details about this role, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to

Company Name:

Key People


Catherine House,Adelaide Street


Staffing Firms


United Kingdom





less than 100




St Albans

Phone No. :

01727 817 626

Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit

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