About fme Life Sciences:

fme Life Sciences focuses on Business Solution deployments leveraging Enterprise Content Services platforms for clients in the Life Sciences Industry. fme Life Sciences is increasingly regarded as a trusted vendor and partner by its clients, who range from small and emerging start-ups to large global pharmaceutical companies. The company is widely regarded as a leader in providing business consulting, systems integration, and ongoing support services focused on Content Services and its applicability to business-critical solutions, including RIM, Regulatory, Clinical and QMS. fme is partnered with the leading Business Solutions and ECM vendors supporting the Life sciences industry, including Veeva Vault, OpenText Documentum, Generis CARA, Honeywell TrackWise and TrackWise Digital, and Alfresco.

fme’s priority is client satisfaction and assisting them with determining the most effective way to deploy mission-critical technologies. We focus on three aspects: business process consulting, technology platform implementations, managed services, and data/document migration services. This ability to provide business insight to supplement the client's internal expertise and execute efficiently and cost-effectively is a crucial feature of our services and differentiates us from our competition.

Job Description:

In the Senior Business Analyst - Life Sciences role at fme Life Sciences, you will drive project management and business analysis activities for Life Sciences projects. You will lead and manage projects from initiation to completion, ensuring they are delivered on time, within budget, and to client specifications. Additionally, you will support business technology and migration consulting projects, primarily in Regulatory Affairs. This includes gathering business and functional requirements, facilitating workshops to define new business processes and data architectures, and driving user adoption through training and change management activities. You will also document content and data migration transformation mapping rules, support validation, and user acceptance testing (UAT).

Key Responsibilities:

Business Analysis:

• Process Analysis: Conduct a thorough process analysis to identify efficiency opportunities and improvements.
• Requirements Analysis: Analyze business and functional requirements, ensuring comprehensive documentation and clarity.
• Content and Data Mapping: Develop and document source-to-target content and data mapping and rules within the Mapping Specification.
• Data Quality Review: Conduct data quality reviews and gap assessments to support migrations.
• Change Management: Support change management and communication activities to foster a success-oriented and accountable environment.
• Documentation: Prepare regular written and verbal presentations, technical documents, and reports.
• Team Collaboration: Work effectively in a team, taking on different roles as needed based on project requirements.
• Multitasking: Manage multiple tasks in a fast-moving, ambiguous environment, demonstrating resourcefulness in setting priorities.
• Migration Planning: Contribute to the strategic elements of migration plans, ensuring a clear and concise description of the overall migration process.

Requirements

Competencies, Experience and Education:

• Experience: Minimum of 10 years of business/process analysis within information management consulting experience REQUIRED.
• Experience with validated systems implementations and business solution deployments leveraging enterprise content services platforms.
• Regulatory Information Management: Experience in Regulatory Information Management (RIM), including Veeva RIM, is required.
• Technical Skills: Experience with Documentum, Generis, Veeva Vault, or migration projects REQUIRED.
• Stakeholder Management: Experience working with Regulatory Affairs teams, business process owners, IT, and client-side leadership.
• Travel: Ability to travel occasionally to client sites across the United States and internationally when necessary.
• Applicants must be eligible to work in the United States without employer sponsorship, now or in the future.
• Education: Bachelor's Degree in a related field is preferred.
• Workshop Facilitation: Experience facilitating workshops is preferred.
• Migration and Validation: Hands-on experience with migration mapping, data quality assessment, and supporting validation and user acceptance testing (UAT) is preferred.
• Certifications: Certifications on leading R&D technology platforms are a plus but not required.

Benefits

• Medical, Dental & Vision plans
• 401k with company match
• Life Insurance, Short & Long-term Disability Plans
• Paid Time Off (Vacation, Sick/Personal & 10 Paid Holidays)
• Employee Referral Program
• Training & Development & Company Retreats
• Wellness Resources/Employee Assistance Program