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Randstad US remote principal business analyst (pharma/gxp) in cambridge, Massachusetts

remote principal business analyst (pharma/gxp).

  • cambridge , massachusetts (remote)

  • posted 10 days ago

job details

summary

  • $80 - $90 per hour

  • contract

  • bachelor degree

  • category computer and mathematical occupations

  • reference1064491

job details

job summary:

Client has one of the most exciting pipelines in the Biotech / Pharmaceutical industry. Along with this growth comes a number of exciting opportunities to work with our expanding business areas. Within Research & Development (R&D) IT, there is a need to support the Regulatory Affairs organization team as a contract Business Analyst.

MUST HAVE

  • MUST have GxP and or CFR 21 Part 11 and systems validation.

  • Life Sciences, Biotech or pharmaceutical industry experience

  • An understanding of non-clinical or regulatory is preferred.

Location: 100% Remote

location: CAMBRIDGE, Massachusetts

job type: Contract

salary: $80 - 90 per hour

work hours: 8am to 4pm

education: Bachelors

responsibilities:

S/he will be expected to partner with the Principal Business Analyst and the Regulatory organization to support a suite of systems.

The key activities for this position include:

  • Lead/Co-Lead requirements elicitation sessions

  • Develop process knowledge to translate to business and technical requirements

  • Documentation of business processes and use cases

  • Author of SDLC deliverables for review

  • When required, support complex data migration activities, including Excel data mapping and repeated load processing activities

  • Provide appropriate technical/functional software support throughout the life of the project

  • Assist in testing preparation and implementation of new application

  • Support development of training materials and facilitation of end user training sessions

  • Contribute to the creation of operational support documentation

  • Determine systems retirement/data archiving requirements and execute via standard processes, as needed

  • Complete other ad hoc tasks requested of Principal Business Analyst

Qualifications:

  • strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors.

  • 5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies.

  • Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner.

  • Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction.

  • Experience with GxP, CFR 21 Part 11 and systems validation.

  • Life Sciences, Biotech or pharmaceutical industry experience

  • Regulatory and/or Parexel Insight Manager knowledge a plus.

qualifications:

  • Experience level: Experienced

  • Education: Bachelors

skills:

  • Business Analysis

  • GxP / CFR 21 Part 11

  • regulatory / non clinical

  • pharmaceutical / life sciencesEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.

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