Responsible for application governance of all applications within Quality, Regulatory, R&D, Clinical, Training and Legal. You will have a key role in the digitalization journey within all these functions. You are responsible for establishing great business partnership with key business stakeholders and together develop strategic and tactical application roadmaps. You will have some operational duties like project management, vendor management and performing configuration changes as well as providing general IT support (incident/problem).
Reports to CIO.
Key tasks and responsibilities
- Application Governance
- Application lifecycle management
- Business process management
- System configuration
- Change control incl validation
- Periodic review of validated applications
- Training of new users
- Super User support
- Systems administration (User admin, Guides, News, etc.)
- Hosting and managing Business System Boards
- Business need to IT solution
- Communication with key stakeholders
- IT Service Management - establish effective service contracts and follow-up services are being executed as per contract
- Service Control
- Service Compliance
- IT System Admin of the applications and work closely with the Business System admins
- Responsible for compliance to regulations and internal SOP’s (Incident/Problem management, Change management and Release management
- Drive user adoption of assigned applications
Education and experience requirements
- Education; Bachelor’s degree in IT or Business
- Work experience; 10+ years in working with systems in this space
- Regulated Pharma Processes in the areas of Clinical, Regulatory and QA
- Learning management process experience (either regulated or non-regulated)
- Legal process awareness
- System experience: Veeva Vault is required– Quality Docs, RIM, eTMF, Training (or other Learning management solutions)
- General IT; Microsoft Office, Teams, Planner, Sharepoint, etc.
- Beneficial; Veeva Promomats, Veeva Medcomms; AgiLoft, Application integration
Reasons to join the Calliditas Team
- Be a part of a global leader in IgA-Nephropathy and a rapidly growing commercial-stage pharmaceutical company within specialty products with strong growth ambitions and a strong pipeline
- Fast paced small company environment
- A unique corporate culture
- Dedicated, experienced and highly skilled colleagues
- Participate on bonus and benefit programs
Calliditas is a commercial stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.
Calliditas’ lead product, developed under the name Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO® and conditional marketing authorization by the European Commission under the trade name KINPEYGO®.
TARPEYO® and KINPEYGO® are the first and only treatments approved for IgA nephropathy by the FDA and EMA, respectively.
Calliditas also has a pipeline in orphan-focused indications. Calliditas is conducting a Phase 2b/3 clinical trial in primary biliary cholangitis and a Phase 2 proof-of-concept trial in head and neck cancer with its NOX inhibitor product candidate, setanaxib.
Calliditas’ common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT).
Welcome to join the Calliditas Team!