(Senior) System Manager, R&D Business Systems Management

March 4, 2024
Application ends: April 29, 2024
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Job Description

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 more (Senior) System Managers to help us maintain, develop, and operate our enterprise electronic document management system (EDMS) – GenDocs, covering the clinical, regulatory, CMC and Quality Assurance areas in R&D. GenDocs is a global IT system based on the Veeva Vault cloud platform and it supports our dynamic and expanding R&D organization in Genmab.

R&D Business Systems Management is a global IT application team located in US and in Denmark 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 the system.

As a System Manager, you will implement new IT functions and features in the system to improve and optimize the business processes in the line of business departments. This will be done in close collaboration with the rest of the team, the line of business departments, and the vendor of the system. You will act as a functional lead where you participate and contribute to the configuration and development of the system 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 experience, and experience with GxP and system validation requirements.

We are seeking a System Manager within each of the system management areas: Veeva Vault Quality (QDocs, QMS, LMS), Regulatory (RIM), and Clinical (eTMF). It is a great opportunity for you to work and develop your competences 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 the optimization and innovation of the GenDocs system (Veeva Vaults) and/or 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 system
Continue to improve procedures, work instructions, templates, and other tools to optimize the system and related processes for operating and maintaining the system
Participate in future Veeva Vault projects as (Senior) Functional Lead, or as (Senior) Project Manager
Maintain the system documentation during the operation of the system
Liaise with line of business departments and IT Business Partners to align plans for new features and projects for the future development of the system
Prepare and participate during audits and inspections of the systems

Requirements

We expect that you have a bachelor’s degree e.g., Life Science, IT, Engineering or similar
You have at least 5-10 years of experience from the pharmaceutical or biotech industry and +5 years 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 clinical development, regulatory affairs, quality assurance, 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 both Danish and 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.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website https://www.genmab.com/privacy.

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

About Us

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Apply via. this link: https://genmab.wd3.myworkdayjobs.com/en-US/Genmab_Careers_Site/details/XMLNAME–Senior–System-Manager–R-D-Business-Systems-Management_R9062?locationCountry=49ab063f422741e2aef271de00efeac8&locations=41c11cb1d9c4016f2f5b93661b15dc2d