Regulatory Systems IT Specialist with Passion for Innovative Cancer Treatment
1 month ago
About Genmab
We are a biotech company committed to building extraordinary futures together. Our mission is to transform the lives of patients through innovative cancer treatment and serious diseases. We believe that being uniquely authentic, determined to be our best, and impact-driven is essential to fulfilling our purpose.
The Role
We are looking for a (Senior) System Manager to help us maintain, develop, and operate our enterprise electronic document management system (EDMS), GenDocs, covering clinical development, regulatory affairs, CMC, and QA areas in R&D. GenDocs is a global IT system based on the Veeva Vault cloud platform and supports daily operations in our dynamic and expanding R&D organization.
Key Responsibilities
- Ongoing optimization and innovation of the GenDocs system (Veeva Vaults) and docuBridge, including related processes in line of business.
- Daily system management work, such as configuring, implementing, and validating new system features and functions.
- Resolving daily issues and incidents from users of the systems.
- Improving procedures, work instructions, templates, and other tools to optimize the systems and related processes for operating and maintaining the systems.
- Participating in future Veeva Vault projects as (Senior) Functional Lead or (Senior) Project Manager.
- Maintaining system documentation during operation of the systems.
- Liaising with line of business departments and IT Business Partners to align plans for new features and projects for future development of the systems.
Requirements
- Bachelor's degree in Life Science, IT, Engineering, or similar field.
- At least 5-8 years of experience in the pharmaceutical or biotech industry, with 3-5 years' experience in a similar role as System Manager.
- Practical work experience with EDMS systems, preferably Veeva Vault administrator and platform certification.
- Advantageous: worked or collaborated with regulatory affairs, clinical development, pharmacovigilance, or similar line of business areas.
- Extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management.
- Participated in IT GxP projects as project SME, (Senior) Functional Lead, or (Senior) Project Manager.
- Excellent communication skills in English, written and oral.
- Experience with IT test tools like HP ALM, Jira, etc., advantageous but not required.
About You
- You are passionate about our purpose and genuinely care about transforming the lives of patients through innovative cancer treatment.
- You bring rigor and excellence to all that you do, believing 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 doing so.
Salary
$120,000 - $180,000 per year, depending on experience.
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