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Job Descrption

About fme:

fme Life Sciences focuses on Business Solution deployments leveraging Enterprise Content Services platforms for clients in the Life Sciences Industry. fme 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:

As a Project Manager/Business Analyst in 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:

Project Management:
• Project Governance: Establish and maintain program governance structures and processes, including regular meetings, reporting mechanisms, and decision-making frameworks across fme and client leadership.
• Project Leadership: Lead client-facing meetings with technical lead support as well as hold regular technical team meetings to measure progress, address questions, and support the remediation of project challenges.
• Project Planning and Performance Management: Lead and provide direction and guidance for a wide array of activities associated with project planning and management to ensure that all assigned projects are completed on time, within budget, and to client specifications. Monitor the performance of projects, tracking key metrics and milestones to assess progress and identify areas for improvement.
• Stakeholder Management: Serve as the primary point of contact for project stakeholders, including senior management (client and fme), client project management, and external partners, communicating program status, risks, and issues regularly. As required, present periodic project status presentations to the fme C-Suite and PMO and client leadership.
• Resource Allocation: Assign and oversee daily tasks of the designated technical personnel in collaboration with the technical lead to ensure adherence to the project timeline and completion of tasks in alignment with established project milestones.
• Risk Management: Identify and mitigate risks and issues that may impact project delivery, working closely with project managers and stakeholders to develop mitigation strategies.
• Quality Assurance: Adhere to the ISO 9001: Quality Management standard and processes and confirm project deliverables meet quality standards and comply with relevant regulations and requirements.
• Methodology: Adhere to fme formal project management methodology for all projects.
• Change Management: Main point of contact and accountable for the management of changes to project scope, schedule, and budget, assessing the impact on the program and implementing appropriate change control processes.

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.

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.
• Project Management: Demonstrated project management skills.
• Analytical Skills: Superior conceptual thinking, analytical, and problem-solving skills.
• Communication: Strong verbal and written communication skills at all levels.
• Decision Making: Strong decision-making, judgment, and analytical skills.
• Collaboration: Proven ability to collaborate effectively with cross-functional virtual teams.
• Regulatory Information Management: Experience in Regulatory Information Management (RIM) is preferred.
• Certifications: Certifications on leading R&D technology platforms are a plus but not required.
• Travel: Ability to travel to client sites across the US and potentially internationally when necessary.
• Education: Bachelor's Degree in a related field.
• Technical Skills: Experience with Documentum/Generis/Veeva Vault/IT and/or migration projects REQUIRED.
• Interpersonal Skills: Effective interpersonal, communication, and presentation skills.
• Problem-solving: Collaborative approach to problem-solving.
• Self-motivation: Self-motivated and directed.

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