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Business Analyst - Regulatory Affairs

  • Gehalt: CHF78 - CHF82 per hour
  • Art der Stelle: Contract, Full-time
  • Ort: Kaiseraugst
  • Berufsbereich: Business Analysis, Content / Document Management, Pharma & Life Sciences
  • Datum der Ausschreibung: 05.06.2019
  • Job ID: BBBH104569

Business Analyst - Regulatory Affairs

Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across a number of professional sectors, with IT being at the heart of our operations.

For one of our clients, specialized in the pharmaceutical area with HQ in Basel, we are looking for a Business Analyst with strong experience in Regulatory Affairs and/or Clinical Development.

This is a challenging contracting position starting in July until the end of the year with extension possibilities.

Tasks & Responsibilities:

  • 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

Requirements:

  • Bachelor's degree in Computer Science, Life Sciences or similar
  • 5+ 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.
  • 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 (e.g. 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
  • 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
  • Knowledge of Regulatory industry standards like eCTD, CTD, SPL, PIM desired
  • Experience in Documentum / OpenText related solutions.
  • Experience in multi-site deployment project

Location: Kaiseraugst

Start Date: 01.07.2019

If you are a result-oriented Business Analyst currently looking for a challenging new position that applies to your skills, then we look forward to receiving your application!


Not the right job for you? Since new jobs are coming in every day just give us a call +41 (0)61 282 22 17. Experis, the leading IT recruitment agency in Switzerland has many open jobs, just browse our website now to find interesting professional opportunities!

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