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Product Development (PD) at Client is committed to accelerating CMC development to launch through strategic investments in Client development and manufacturing platforms, new development playbooks, and advancing innovation though modeling, AI/Client, and automation. In this role, the data integrator will be responsible for collecting and curating data for use in predictive models across a range of use cases focusing on accelerating process development.

<div> Data Integrator Onsite--New Brunswick Work Schedule: Mon - Fri, Business Hours Product Development (PD) at Client is committed to accelerating CMC development to launch through strategic investments in Client development and manufacturing platforms, new development playbooks, and advancing innovation though modeling, AI/Client, and automation. These specific strategic investments are known as our Development Excellence strategy. As part of this organization, the Product Development Strategy group is accountable for developing a holistic digital and modeling strategy and its global integration and implementation. We are seeking a highly motivated scientist to join the Modeling and Digital Strategy group as a data integrator. In this role, the data integrator will be responsible for collecting and curating data for use in predictive models across a range of use cases focusing on accelerating process development. The role will participate in highly visible and agile cross functional teams with scope spanning the digital and modeling space. They will collaborate closely with partners within PD such as drug substance, drug product and analytical functions as well as with business partners such as IT. This role will report to the Sr Director, Product Development Strategy. Responsibilities •Collect and curate data from multiple sources including electronic notebooks, spreadsheets, slide decks, and instrument files •Ensure data quality, consistency, and completeness across different data sets •Apply data standards, ontologies, and metadata to facilitate data integration and analysis •Support data discovery, access, and sharing across the organization •Collaborate with scientists and engineers to identify data sources and locations, understand data requirements and challenges, and provide data solutions •Communicate and translate between life science experts and data engineers Qualifications •Bachelor's degree or higher in a relevant field such as chemical engineering, life sciences, data science, or computer science •At least 2 years of experience in process development or data analysis in the pharmaceutical industry or a related domain •Familiar with data standards, ontologies, and metadata for pharmaceutical process development data •Excellent communication and interpersonal skills to work effectively with diverse stakeholders •Strong problem-solving and analytical skills to handle complex and large-scale data challenges •Self-motivated and proactive to learn new skills and technologies</div>

TechDigital Corporation

Product Development - Data Integrator

TechDigital Corporation Jobs

Develop a 'playbook for success' defining key metrics, how to interact with the Business Units (BUs), how to manage specific situations, communication strategy to senior level stakeholders in the BUs, incl. • Integrate into the Commercial organization (Patient Support, Pharmacovigilance (PV), Country Quality, Medical, Regulatory, Clinical) as a business partner to proactively identify, navigate, and drive Quality risk discussion and avoidance.

<div> Role & Responsibilities • The Business Integrator role will work within the Risk Management/Inspection Readiness (RMIR) Pillar of the North America Quality Organization (U.S. and Canada) to help shape and define this role. • Integrate into the Commercial organization (Patient Support, Pharmacovigilance (PV), Country Quality, Medical, Regulatory, Clinical) as a business partner to proactively identify, navigate, and drive Quality risk discussion and avoidance. • Assess and prioritize risk, and balance the needs of each country's Business Units (BUs). • Foster Quality culture and collaboration and translate activities into functional, executable plans including metrics, milestones and timelines. • Collaborate and engage with multiple BUs (multi-channel engagement) to understand ongoing activities to allow the Quality organization to provide a risk perspective. • Structure a communications framework, e.g., if formal quarterly meetings, what is the communication plan between meetings for the various stakeholders across the BUs and Quality • Develop a 'playbook for success' defining key metrics, how to interact with the Business Units (BUs), how to manage specific situations, communication strategy to senior level stakeholders in the BUs, incl. country Counsel. • Evaluate the GxP processes throughout the operation, and propose dashboard activities for trending which can support various stakeholder communications, action plans, and milestones. The dashboards will help us articulate and present key data collection, and use it to translate risk priorities or areas for focused improvement within the business units. • Work with two internal client resources who have been engaged with parts of this initiative to share perspectives on what has worked and not worked......draw on your experiences to share approach(es) that have been successful. • Shape the longer term organizational mindset change and mission, while solidifying excellence in this evolving arena. Skills • Seasoned Quality minded professional with Life Sciences experience required, likely 15+ years' experience • Has demonstrated experience working across business units with senior management • Demonstrated experience integrating quality risk discussion with commercial operations as defined below • Risk management and Enterprise risk tolerance experience (Quality risk) • Commercial business acumen, collaboration, relationship building and negotiating prowess o Commercial operations related to patient support, e.g., Pharmacovigilance (PV), Country Quality, Medical, Regulatory, Clinical</div>

OQSIE

Business Integrator -Quality & Commercial Operations

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Product Development - Data IntegratorTechDigital Corporation

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