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.
Desired Skills & Experience
• 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.
Good to Have
• 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.