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Business Analyst Resume

SUMMARY:

  • As a Business Analyst, you will be a key player in the consulting team that helps discover and define the problem statement, evaluates the solution options and makes recommendations.
  • You will create detailed functional design architecture and process artifacts and support the validation from a SME perspective and involve in user acceptance.
  • You will also support knowledge transfer with the objective of providing value - adding consulting solutions that enable our clients to meet the changing needs of the global landscape.
  • 4 - 10 years of experience in life sciences research and development area and good understanding of key business processes around Commercial, Clinical, Regulatory & Safety.
  • Experience with modeling business processes, data flows, and workflow processes depicting relationships between data entities.
  • Knowledge of Software Development Life Cycle processes
  • Strong business consulting skills associated with medium / complex IT system implementation spanning over 6-12months.

PROFESSIONAL EXPERIENCE:

Confidential

Business Analyst

Responsibilities:

  • Expertise in more than one subject area like Clinical Trials, regulatory submission process, regulatory information management systems including product registration and tracking, labeling etc.
  • Good knowledge of business processes in EVMPD/IDMP /Product License Tracking (small molecules/Med devices/biologics)
  • Good exposure to regulatory document / content management systems and submission authoring assembly of eCTD / Chemistry Manufacturing Control (CMC) including hands on exposure the submission requirements and types of submission and associated regulations pertaining to different health authorities, especially FDA and EMA
  • Good Knowledge and Labeling process and systems (Above country, In country, SPL)
  • Must have performed requirement analysis, use case modeling, etc. from a business analysis/consulting standpoint.
  • Must be able to translate business requirements into well-formed technical and system requirements
  • Experience in Business analysis methodologies and processes
  • Strong communication skills, planning and Co-ordination skills, Stakeholder management, Good Knowledge of SDLC processes.

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