Data Strategy & Analytics Consultant - Digital CMC

Responsibilities:

* Working in a support function with IT and the digital CMC workstream leads to define and design the data strategy: data usage, identify the types and sources of data that will be collected.

* Support data governance policies, define data quality standards, and assist in determining the technology infrastructure and tools needed to support the data strategy at a day-to-day level.

* Support strategic initiatives in analytical knowledge transfer and regulatory authoring

* Efficiently identify, assess, acquire, and manage data to gain insights for strategic advantages in line with FAIR principles.

* Assit in creating analytics-ready data, support EA principles, and capture information from ongoing POCs to meet service target selection needs in the future state.

* Assist in the implementation of semantic layer that will serve as a common language that enables consistent interpretation and representation of data elements, their relationships, and their contextual meaning: establishing a logical and structured framework to bridge the gap between different data sources, systems, and formats.

* Effectively communicate complex data concepts to various cross-functional stakeholders, work collaboratively with cross-functional teams, and build consensus around data and systems initiatives, with an enterprise mindset.

* Leading through influence to identify and address cross-divisional situations and proactive risk identification and mitigations that are embedded within the workstreams and digital CMC (as it faces the enterprise)

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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Qualifications:

* 4+ years of experience in the pharmaceutical/biotech industry supporting digital transformation initiatives

* Thorough understanding of drug development - having a degree in a life sciences-related field is highly preferred

* Experience in data strategy, digital transformation, and data management in a CMC environment

* Knowledge of data principles and sources related to tech transfer, analytical development, and regulatory filings

* Ability to effectively communicate complex data concepts to diverse stakeholders

* Hands-on experience with process and knowledge management systems, data sources/sourcing, and export systems.

* Proficient in LIMS, ELN, MES, --ERP, SAP, DeltaV, and familiar with CRO/CMO sources.

* Able to map business processes by connecting with subject matter experts and provide a detailed representation of business step and data flow.

* Able to conduct detailed inquiry on business process: identify pain points and opportunities for improvement on both business and data flow.

* Able to visually present the outcomes with clarity to both business and IT leaders, assist the process of solutioning by creating consensus with a technology and enterprise mindset.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.