(Senior) System Manager, Regulatory Systems Management, Veeva RIM

2 weeks ago

Copenhagen, Denmark Genmab Full time

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The role

Genmab is looking for a (Senior) System Manager to help us maintain, develop, and operate our enterprise electronic document management system (EDMS), GenDocs, covering the clinical development, regulatory affairs, CMC, and QA areas in R&D.
GenDocs is a global IT system in Genmab based on the Veeva Vault cloud platform and it supports daily operations in our dynamic and expanding R&D organization.


Digital Systems Management is a global IT application team located in US and in Europe which supports, develops, and innovates IT systems, primarily Veeva Vaults, and processes in R&D. We do this by working closely together with the line of business departments, understanding, and bridging their business needs to optimized systems.

As a System Manager in Digital Systems Management, you will implement new IT functions and features in the systems to improve and optimize the business processes, especially in the regulatory systems domain, like Veeva RIM and docuBridge.

This will be done in close collaboration with the rest of the team, the line of business departments, and the vendors of the systems. You will act as a functional lead where you participate and contribute to the configuration and development of the systems with different SME´s from line of business, the vendor, and our own team.


An important part of the role is to be in near contact with line of business departments to handle their requests, questions, or need for help. This requires a good combination of IT system knowledge, business process understanding and experience, and experience with GxP, system configuration and validation.


This is a great opportunity for you to work and develop your competences and skills within an IT system team and get first-hand experience of how a biotech company operates. The position also involves communication with external vendors, and with end users in line of business through projects, network groups, daily tasks etc.

Responsibilities

  • Lead and contribute to the optimization and innovation of the GenDocs system (Veeva Vaults) and docuBridge, and their related processes in line of business
  • Participate in the daily system management work, for example configure, implement and validate new system feature and functions
  • Participate in the resolution of daily issues and incidents from users of the systems
  • Continue to improve procedures, work instructions, templates, and other tools to optimize the systems and related processes for operating and maintaining the systems
  • Participate in future Veeva Vault projects as (Senior) Functional Lead, or as (Senior) Project Manager
  • Maintain the system documentation during the operation of the systems
  • Liaise with line of business departments and IT Business Partners to align plans for new features and projects for the future development of the systems
  • Prepare and participate during audits and inspections of the systems

Requirements

  • We expect that you have a bachelor’s degree e.g. in Life Science, IT, Engineering or similar area
  • You have at least 5-8 years of work experience from the pharmaceutical or biotech industry, and 3-5 years’ experience from a similar role as system manager
  • You have practical work experience with EDMS systems, and preferably Veeva Vault administrator and platform certification
  • It is an advantage if you have worked or collaborated with regulatory affairs,  clinical development, pharmacovigilance, or a similar line of business areas during your career
  • You have extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management
  • You have participated in IT GxP projects, either as project SME, (Senior) Functional Lead, or (Senior) Project Manager
  • You have excellent communication skills in English, written and oral
  • It is an advantage but not a requirement if you have experience with IT test tools, like HP ALM, Jira, etc.

Moreover, you meet the following personal requirements:

  • Ability to work independently as well as in teams
  • Service minded and meeting challenges with a smile and a positive mindset
  • Pragmatic attitude, able to balance, and see other people´s perspective
  • Take responsibility and have a personal drive
  • Structured and systematic, and can adapt the level of right detail to the context

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds
  • You are determined to do and be your best and take pride in enabling the best work of others on the team
  • You are not afraid to grapple with the unknown and be innovative
  • You have experience working in a fast-growing, dynamic company (or a strong desire to)
  • You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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