GREX-0, Senior Specialist Business Intelligence and Regulatory Data Analytics
Merck
Bangalore, India
2d ago

A career at our company is an ongoing journey of discovery : our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics.

For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.

Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life.

Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role :

  • Supports making data-driven decisions by extracting, validating, interpreting, preparing, and analyzing large amounts of data to deliver high-quality, complex, and timely analytics reporting.
  • These analyses and reports will provide stakeholders with the data they need to make informed decisions in daily operations and strategic planning initiatives.

  • Should be familiar with data sources and data models from various regulatory systems to build queries, retrieve, transform, load and aggregate data in understandable and usable formats.
  • Work collaboratively with various stakeholders across GRA and across R&D to determine and meet their regulatory analytics needs and is also responsible for assisting in any regulatory reporting on data / metrics as needed.
  • Work with internal stakeholders to acquire business knowledge regarding the appropriate use of data elements, establish and maintain common business rules, and ensure consistency in reporting across the organization.
  • This role will be responsible for troubleshooting data integrity issues, analysing data for its completeness and ability to meet business needs, and proposing solutions or recommendations.
  • This role include includes but is not limited to data exploration and visualization, delivering static and dynamic reports, dashboards, and statistical or predictive analysis tools.
  • Modification of the existing reports to add additional information and reflect the real time data in the system.
  • Support Big data / Regulatory Data Objects environments to support the reporting and analytics solutions.
  • Regulatory Data Governance : Defining together with Regulatory Data Governance lead unambiguously the framework of driving forward efficient information management.
  • Define information management standards and principles (e.g. FAIR, ALCOA+).

  • Regulatory Data Quality : Defining goals, approaches and plans of action to ensure that data content is of sufficient quality to support defined business and strategic goals of the organization.
  • Regulatory Digital Transformation : Transforming the GRA organization into a new state based on the integration and synergies of digitalization efforts, resulting in fundamental changes to how businesses operate and deliver value, e.
  • g. automation of Regulatory Affairs (related) processes. Drive the Vault Reporting and Analytics topics.

  • Data submission to health authorities : Ensure compliance to health authority requirements on data submissions by defining and implementing Regulatory data governance, data quality, data operations and data architecture considering new and advanced technologies to reduce human factory work.
  • Impact

  • Define and implement data analytics for all the supporting application / Data from RC&RIM
  • Liaise with Health Authorities on data submission topics (e.g. IDMP)
  • Contributes to define the strategy of the Regulatory Compliance & Regulatory Information Management Department
  • Educate on data literacy for regulatory data
  • Who you are : Education

    Education

  • Basic degree.
  • Excellent Analytics and reporting tools background
  • Excellent RIM database and SQL query background
  • Good knowledge of current regulatory data standards
  • Fluent command of spoken and written English
  • Work Experience

  • Master’s / Bachelor Degree in life science, pharmacy or pharmacoinformatics, computer science, business / data analytics, business information systems or equivalent field with 6+ years relevant experience.
  • Passionate for working with data. Not afraid to ask relevant questions to stakeholders.
  • Prior Knowledge or working experience in Veeva systems is an advantage.
  • Creates reporting and analytics solutions with appropriate oversight that support the quality and timely delivery of reports and visualizations required.
  • Proven knowledge of drug development processes and understanding of drug R&D departments, e.g., Regulatory Affairs, Biostatistics, Drug Safety, Clinical Operations
  • Extensive knowledge on technologies and trends related to Research and Development, including big data and advanced analytics.
  • Prior experience in computerized systems validation (CSV) and testing methodology with awareness of the risks, issues, and activities involved in these processes
  • Versed in TIBCO Spotfire / Tableau or any other analytical platform and able to incorporate and influence their use in reporting solutions.
  • Advanced SQL, Data Visualization, Modelling and Wrangling skills.
  • Strong Customer Facing skills and experienced in training end users of all levels in the use of analytical platforms.
  • Prior Knowledge of R and Python is an advantage.
  • Experienced working in iterative and agile working environments.
  • Leading, influencing, and consulting skills.
  • Adept at translating business requirements into appropriate reporting and dashboard / scorecard.
  • Strong desire and ability to learn, adapt and apply new technologies.
  • Job specific Competencies & Skills

  • High attention to detail and strong organizational skills, work independently, self-motivated and proactive.
  • Ability to establish close communications and working relationship with cross functional teams to meet business objectives.
  • Ability to work with uncertainties and effect innovative solutions to complex regulatory requirements.
  • Strong negotiating, influencing and interpersonal skills especially regarding indirect people leadership in a matrix organization.
  • Results-oriented, entrepreneurial and self-motivated.
  • Goal-oriented, pragmatic, meticulous working style, high attitude to quality.
  • Strong service mentality.
  • Strong verbal and written communication skills.
  • Location : Electronic City, Bangalore

    What we offer : With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons.

    We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life.

    Join us and bring your curiosity to life!

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