Business Analyst(Pharma or medical writing experience)

Location:

LinkedIn link: UBI LinkedIn

About UsefulBI:

data, AI, and digital transformation

Role Overview:

Business Analyst

Key Responsibilities:

• Act as the primary liaison between

  business stakeholders and technical teams

  , translating business needs into clear functional and technical requirements.
• Conduct

  requirement-gathering sessions

  , stakeholder workshops, and process mapping to define project scope and deliverables.
• Collaborate closely with Product, Engineering, Cloud, and Infrastructure teams to support smooth SaaS solution delivery.
• Align solutions with

  global regulatory standards

  (FDA, EMA, MHRA, 21 CFR Part 11) to ensure compliance.
• Support

  UAT planning

  , test case creation, validation, and issue resolution.
• Analyze existing processes and recommend data-driven improvements to enhance efficiency and scalability.
• Build and maintain reports and dashboards to track project milestones, risks, and delivery progress.
• Partner with global and cross-functional teams to ensure seamless execution and stakeholder satisfaction.

Required Skills and Experience:

• 7–8 years of experience as a

  Business Analyst

  in

  healthcare, pharma

  , or regulatory technology.
• Proven expertise in

  requirement gathering

  ,

  functional documentation

  , and

  stakeholder management

  .
• Strong knowledge of

  agile methodologies

  and SaaS implementation frameworks.
• Hands-on experience with tools like

  JIRA

  ,

  MS Project

  ,

  Smartsheet

  ,

  Veeva Vault Promomats

  ,

  Google Suite

  ,

  NetSuite

  , and

  SharePoint

  .
• Excellent communication skills with the ability to engage effectively with business and technical teams.

Preferred Qualifications:

• Bachelor’s degree in

  Biotechnology

  , Life Sciences, or a related field.
• Google Project Management Certification or equivalent.
• Knowledge of

  European Medical Device Regulations

  and GxP compliance.
• Exposure to

  AI-driven regulatory platforms

  (e.g., Ai RegIntel).