Randstad
remote principal business analyst (pharma/gxp)
Randstad, Cambridge, Massachusetts, us, 02140
remote principal business analyst (pharma/gxp).
cambridge , massachusetts (remote)
posted september 4, 2024
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.
cambridge , massachusetts (remote)
posted september 4, 2024
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.