Job ID: JOB_ID_4295
Job Summary:
We are seeking a highly analytical and detail-oriented Sr. Business Analyst with a strong background in the pharmaceutical or MedTech industry. The ideal candidate will possess excellent problem-solving skills and experience working in regulated environments. This role requires a deep understanding of pharmaceutical business processes, quality management systems, and compliance frameworks. You will be responsible for translating business needs into clear functional requirements, managing stakeholder relationships, and ensuring solutions align with regulatory standards.
Key Responsibilities:
- Analyze, evaluate, and translate business and user requirements into clear specifications for development, test, and cross-functional teams.
- Develop user stories, acceptance criteria, and backlog items aligned with business scope and priorities.
- Engage with business stakeholders to understand functional processes and pain points within pharma quality management workflows.
- Ensure all solutions meet relevant regulatory, security, privacy, and compliance standards required in the pharmaceutical environment.
- Support user acceptance testing (UAT), system training activities, and documentation aligned with GxP expectations.
- Collect and document functional requirements from stakeholders through interviews, workshops, and surveys.
- Analyze data to identify trends, patterns, and insights to inform business decisions.
- Manage stakeholder expectations and negotiate priorities between technical and business teams.
- Coordinate with Technology Quality Partner and Business Owner for requirement analysis, review, and approval.
- Collaborate with development and validation teams for business requirements clarification, ensuring GxP regulations are met.
- Develop functional design documents, process flow diagrams, and other artifacts to illustrate system functionality.
- Work with technical teams to ensure systems are built according to functional requirements.
- Assist the testing team with test plans to ensure systems meet requirements and function correctly.
Essential Skills:
- Business Analysis
- Project Management Experience
- Strong analytical ability and problem-solving skills.
- Experience working in regulated environments (pharmaceuticals or MedTech).
- Understanding of pharmaceutical business processes and compliance frameworks.
- Working experience in Quality Management Processes and Systems in the pharmaceutical domain.
- Ability to translate business needs into clear functional requirements.
- Experience in Business process mapping and requirements gathering.
- Ability to manage relationships with various stakeholders.
- Working knowledge of Agile methodology (User Story management, Continuous Integration, Continuous Testing).
- Experience with Agile tools like JIRA and Confluence.
- Ability to comprehend and map business processes into visual flows.
- Understanding of software development lifecycle.
- Excellent verbal and written communication skills.
Desirable Skills:
- Generic Managerial Skills
- Self-motivated and proactive.
- Ability to manage pressure and show dynamism.
- Attention to detail.
This role requires a Sr. Business Analyst with a strong understanding of the pharmaceutical domain and experience in regulated environments. You will play a crucial role in defining and implementing solutions that meet stringent industry standards.
Special Requirements
Onsite
Compensation & Location
Salary: $100,000 – $140,000 per year (Estimated)
Location: Raritan, NJ
Recruiter / Company – Contact Information
Email: ar@aceitworld.com
Recruiter Notice:
To remove this job posting, please send an email from
ar@aceitworld.com with the subject:
DELETE_JOB_ID_4295