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Business Analyst (Pharmaceutical Regulatory Affairs)
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Support, Library, Client
Projektbeschreibung
For our client in BASEL we are looking for a BUSINESS ANALYST for a 4-MONTH contract.
DURATION: 22/10/2018 TILL 22/02/2019
LOCATION: BASEL
WORKLOAD: 100%
ABOUT THE ROLE:
We are looking for an experienced Business Analyst to join the IDM Team (Integrated Document Management). In this cross-functional, energetic and highly talented team, we are at the forefront of designing, building and operating state of the art content management 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 to expand the functionality and user base of IDM.
TASKS & RESPONSIBILITIES:
. 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.
MUST HAVES:
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.
. Bachelor's degree in Computer Science, Life Sciences or similar
. 5+ years of experience in Business Analysis 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 3 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:
+++ Knowledge of Regulatory industry standards like eCTD, CTD, SPL, PIM desired.
+++ Experience in Documentum/OpenText related solutions.
++ Experience in multi-site deployment project
++ Experience with the tools involved for maintaining a project (Perform, Clarity, Project Library, HPSM, HP ALM, etc.)
For further details please contact Beata Arciszewska:
email: (see below)
DURATION: 22/10/2018 TILL 22/02/2019
LOCATION: BASEL
WORKLOAD: 100%
ABOUT THE ROLE:
We are looking for an experienced Business Analyst to join the IDM Team (Integrated Document Management). In this cross-functional, energetic and highly talented team, we are at the forefront of designing, building and operating state of the art content management 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 to expand the functionality and user base of IDM.
TASKS & RESPONSIBILITIES:
. 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.
MUST HAVES:
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.
. Bachelor's degree in Computer Science, Life Sciences or similar
. 5+ years of experience in Business Analysis 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 3 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:
+++ Knowledge of Regulatory industry standards like eCTD, CTD, SPL, PIM desired.
+++ Experience in Documentum/OpenText related solutions.
++ Experience in multi-site deployment project
++ Experience with the tools involved for maintaining a project (Perform, Clarity, Project Library, HPSM, HP ALM, etc.)
For further details please contact Beata Arciszewska:
email: (see below)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges