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Fusion Life Sciences Technologies LLC ยท 2 days ago
CMC Business Analyst
NYC Metro Area
Contract
Onsite
Mid, Senior Level
5+ years exp
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Responsibilities
Identify the true source documents for previous regulatory filing sections to assist with the prioritization of section digitization. This task involves understanding the existing regulatory filing sections, identifying whether the original source information is digital or not, and then determine if there are other options to access that information digitally. Once Identified, the Analyst will assist with the prioritization of data to digitize.
Assist with the business process mapping of activities to generate data that supports technology transfer and control strategy development. The analyst will collaborate with the Digital CMC team to map out the business processes involved in generating data for technology transfer and control strategy development. This mapping will help identify areas that can be optimized and streamlined using digital tools.
Summarizing complex tasks into easy-to-understand workflows to summarize the current state and identify gaps for further exploration.
Scheduling and hosting information collection consultations with members of the Merck CMC community.
Familiarity with tech transfers, regulatory authoring, control strategy definition, and business process mapping preferrable, but not required
Collaborate with cross-functional teams to gather and analyze business requirements for CMC digitization projects.
Develop detailed business process documentation, including workflows, use cases, and data models.
Support project management activities, including task tracking, status reporting, and stakeholder communication.
Conduct gap analysis and recommend solutions to address process inefficiencies and compliance issues. Liaise with IT, Research, and Manufacturing teams to ensure seamless integration of digital solutions with existing systems. Monitor and report on key performance indicators (KPIs) to measure the success of digitization initiatives.
Qualification
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Required
5+ years of experience as a Business Analyst, preferably in the pharmaceutical or biotechnology industry.
Strong understanding of CMC processes, technology transfer, and regulatory requirements in the pharmaceutical industry.
Proven experience with digital transformation projects, including process automation and data management.
Proficiency in project management and business analysis tools/methodologies, such as MS Project & Lean Methodologies/Agile
Familiarity with digital tools and platforms used in CMC operations (e.g., LIMS, MES) is highly desirable.
Bachelor's degree in Business Administration, Life Sciences, Engineering, or a related field. Advanced degree (MBA, MS) preferred.
Preferred
Familiarity with tech transfers, regulatory authoring, control strategy definition, and business process mapping preferrable, but not required
Company
Fusion Life Sciences Technologies LLC
Fusion Life Sciences Technologies is a Healthcare staffing firm offering Engineering, FDA Remediation and all non IT services for the Pharmaceutical, Bulk Drug Manufacturing, Biotechnology, Medical Device & Automobile industries.
201-500 employees
H1B Sponsorship
Fusion Life Sciences Technologies LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (91)
2022 (130)
2021 (134)
2020 (131)
Funding
Current Stage
Growth StageLeadership Team
R
Rohith Kumar
Co-Founder
Company data provided by crunchbase
