Subject Matter Expert IDMP / Requirements Engineer (m/f/d) Regulatory Information Management
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Ottobrunn, DE
Make the world better with us!
EXTEDO helps health authorities and pharmaceutical companies around the world develop and bring new drugs and vaccines to market faster and more safely.
As an internationally leading provider of software and services in regulatory information management (RIM), we support life sciences organizations in implementing the requirements of the regulatory authorities for their products. Our solutions thus ensure that medicines and vaccinations reach where they are needed faster and, at the same time, more safely: with the patients. Regulatory authorities around the world also rely on us to review submissions and ensure they meet the highest standards of drug safety.
EXTEDO helps health authorities and pharmaceutical companies around the world develop and bring new drugs and vaccines to market faster and more safely.
As an internationally leading provider of software and services in regulatory information management (RIM), we support life sciences organizations in implementing the requirements of the regulatory authorities for their products. Our solutions thus ensure that medicines and vaccinations reach where they are needed faster and, at the same time, more safely: with the patients. Regulatory authorities around the world also rely on us to review submissions and ensure they meet the highest standards of drug safety.
For our location in Ottobrunn near Munich (or in remote within Germany) we are actively seeking a
Subject Matter Expert IDMP / Requirements Engineer (m/f/d)
Regulatory Information Management
As a Subject Matter Expert IDMP/ Requirements Engineer (m/f/d), you will play a crucial role in bridging the gap between our business objectives and technical solutions. Your primary responsibility will be to support the Product Owner in defining requirements, ensuring that our software solutions meet the needs of our clients. You will also support the entire agile product development team, work closely with cross-functional departments and business stakeholders.Your Tasks - as important as our Software:
- Collaborate with the Product Owner to gather, analyze, and document business requirements
- Develop detailed business and functional requirements, including user stories and acceptance criteria
- Work closely with agile product development team to ensure a clear understanding of requirements and support them throughout the development lifecycle
- Conduct regular meetings with stakeholders to refine requirements and manage expectations
- Perform data analysis to support decision-making and problem-solving
- Facilitate communication between business stakeholders and development team
- Assist in developing and maintaining project documentation, including project plans, roadmaps and status reports
- Participate in quality assurance activities to ensure that the final product meets the requirements
- Support user acceptance testing (UAT) and coordinate feedback sessions with stakeholders
Your Profile - as good as our Solutions:
- Sound knowledge of regulatory and quality processes in the life sciences industry
- Knowledge of Article 57/xEVMPD, IDMP/SPOR data incl. Master and Meta Data Management
- Analytical thinking and basic technical understanding
- Experience in the field of software development, experience in agile methodologies is a plus
- Team player with good social and problem-solving skills
- Fluent in English, German is a plus
You are used to working independently and you have already worked in the life science area, especially Regulatory Affairs, Quality or IT environment. You are initiative, goal orientated and assertive and have joy in business development.
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