Job Information
Insight Global Business Analyst - CMC Digitization in Rahway, New Jersey
Job Description
We are seeking a detail-oriented and proactive Business Analyst to join our team and support a pharmaceutical company's CMC digitization initiative. This role will focus on optimizing technology transfer processes, enhancing data management, and improving overall efficiency in CMC operations. The ideal candidate will possess a strong analytical mindset, excellent communication skills, and a deep understanding of pharmaceutical manufacturing and regulatory requirements.
Key Responsibilities:
* Identify the true source documents for previous regulatory filing sections to assist with the prioritization of section digitization.
o 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.
o 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 internal 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.
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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Skills and Requirements
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. null
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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.