Business Analyst (Health Authority/Regulatory Authority)
Posted on Sep 9, 2019 by Harvey Nash IT Recruitment Switzerland
For our client in Kaiseraugst we are looking for Business Analyst (Health Authority/Regulatory Authority) for a 6-month contract.
We are looking for an experienced Business Analyst to join the Trial Execution Network Squads for the topic of informed consent. In this cross-functional, energetic and highly talented team, we are at the forefront of designing, building of the informed consent form systems in the clinical & regulatory domain, putting people at the center of our designs. You will be part of a business analyst team working on the delivery of strategic projects around this topic.
* Start date: 01.10.2019
* Latest start date: 07.10.2019
* End date: 31.03.2020
* Extension: Extension might be possible, but would need to be approved.
* Work load: 100 %
* Work location: Kaiseraugst
* Remote: In agreement with the manager.
* Travelling: up to 10% travelling may be required within EU
* Team: virtual cross-functional global teams
* Department: FPDX
Tasks & Responsibilities:
Your key responsibilities and tasks:
* Is responsible for establishing user requirements (URS) and functional requirements (FS) on the basis of identified business needs. This may include techniques such as using interviews, document analysis, requirements workshops, surveys, site visits, business process descriptions, use cases, and task/workflow analysis.
* Critically evaluates information gathered from multiple sources, reconciles conflicts, decomposes high-level information into details, abstracts up from low-level information to a general understanding, and distinguishes user requests from the underlying true needs.
* Serves as the conduit between the project managers and the software development team and Solution Architect through which requirements flow, including challenging project managers on their assumptions of how they will successfully execute their plans.
* Takes responsibility to ensure that the final solution matches the URS and meets the customers' needs and supports operational services teams in ensuring continued business value realization and business adoption.
* Has a strong understanding for the framework of Computer System Validation and strives for very high quality standards of documentation and adherence to process.
* Connects with the Business Process Owner and business community bringing a value-adding Informatics point of view to help continuously improve business processes and solutions.
* Provide leadership to team members and peers by collaborating with others; articulating ideas and viewpoints to senior management, peers and others; driving the resolution of issues; and holding self and team accountable for results
You are an outgoing, open minded and organized individual with strong communication, influencing and presentation skills. You also possess experience in document management solutions and preferably in performance optimization related projects.
For this position, you bring the following qualification:
* Bachelor's degree in Science.
* (Computer Science, Life Sciences or similar) with 4+ years of business analysis experience.
* In multiple areas of business domain and technology or related field experience with Health Authority/Regulatory Authority.
* Proficient knowledge of pharmaceutical Regulatory and Clinical processes, including knowledge and appreciation of scientific Regulatory affairs, ethical and compliance principles.
* Minimum of 4 years of experience in the area of Regulatory Affairs and/or Clinical Development including the associated application landscape.*
* Strong systems, user and functional requirements analysis and technical skills.
* Ability to support prototyping activities.*that will validate business requirements and solution definition.
* Proven skills in document authoring.* (eg User Requirements Specification, Functional Specifications).
* Proactive and flexible approach to changing objectives, priorities and challenges.
* Proven skills in relationship building, customer-focus, decision-making, and problem solving.
* Ability to recognize and react to situations with a sense of urgency and problem ownership/accountability, with a focus on customer service.
* Ability to deal with confidential matters and privacy appropriately.
* Excellent presentation, meeting facilitation and communications skills (written and verbal in English, other languages are plus).
* Formal training and proficiency in software development methodologies and computer systems validation in regulated industries (biotech/pharma).
* Positive and enthusiastic attitude and interpersonal skills.
* Excellence in functionally leading and coordinating teams in multicultural and virtual environments.
* Be prepared to work outside the standard office hours and according to different time zones as required.
Nice to Haves:
* Experience in Informed Consent topics
* Knowledge of Regulatory industry standards like eCTD, CTD, SPL, PIM desired.
* Experience in leading a team of business analysts
* Experience in multi-site deployment project
* PMM methodology experience and with the tools involved for maintaining a project (Perform, Clarity, Project Library, HPSM, HP ALM, etc.)
For more information please contact Barbara Tenerowicz