- 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.
- 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.