fme Life Sciences

Oversee and manage data and document migration projects to Veeva Vault RIM, leading technical teams and collaborating with stakeholders. | Extensive experience in data and document migration, leadership in life sciences or regulated environments, and technical skills in Veeva Vault RIM, SQL, XML, scripting, and regulatory compliance. | About fme Life Sciences fme Life Sciences focuses on Business Solution technology implementations that leverage Content Services (Document Management) 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, OpenText/Documentum, Generis (Cara), Sparta. 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 and managed services, and data/document migration services. This ability to provide business insight as a supplement to the clients’ internal expertise, and then to execute efficiently and cost effectively on the technical implementation, is a key feature of our services and differentiates us from our competition. Job Description We are seeking a highly skilled and experienced Senior Technical Lead to oversee and drive data and document migration projects to the Veeva Vault RIM platform. This role requires deep technical expertise, strong leadership abilities, and a thorough understanding of the life sciences landscape. As a Senior Technical Lead, you will serve as the subject matter expert, overseeing and managing all technical aspects of the project and leading the technical team. This role requires close collaboration with the Project Manager (PM) and engagement with both internal and external stakeholders, including contractors, to ensure project success. You will work in tandem with the Project Manager, Business Analysts and Technical Consultants to ensure seamless project progression, provide strategic guidance, address technical challenges, and achieve project objectives within the established constraints. The ideal candidate will have in-depth technical expertise in Veeva Vault RIM and the Life Sciences industry. The successful candidate will be adept at collaborating with both Regulatory business and IT teams. As the technical lead, you will be responsible for migrating data and documents for a diverse range of Life Sciences clients, including small, medium, and large enterprises. You will work closely with clients to understand their business objectives, translate those objectives into requirements, and lead the successful migration of solutions. This role involves coordinating with our offshore team and partners to ensure seamless execution. A strong understanding of pharmaceutical validation, documentation practices, and relevant regulations is essential. This role demands outstanding verbal and written communication skills, with the ability to engage effectively with individuals at all levels of an organization. We seek a creative and committed individual who will thrive in and contribute to our collaborative culture. Key Responsibilities / Qualifications Project Planning: Partner with project managers and stakeholders to define project requirements, objectives, timelines, and resource efforts. Break these down into actionable work packages, ensuring they are effectively captured and tracked within development plans. Communication and Collaboration: Serve as the liaison between the technical project team and stakeholders, including project managers, business contacts, and QA teams. Facilitate clear and effective communication, coordinate dependencies, provide timely updates, address concerns or issues promptly, and promote collaboration and teamwork. Team Leadership and Management: Lead and manage a global team of technical consultants, including onshore and offshore employees and contractors, by cultivating a positive, collaborative, and results-oriented work environment that encourages productivity and support. Technical Guidance: Provide technical expertise and guidance to the project team, covering key areas such as architecture and design decisions, code reviews, documentation practices, project execution standards, and best practices. Additionally, ensure the preservation of artifacts and knowledge throughout the project lifecycle. Stakeholder Management: Engage with technical stakeholders to gather feedback, understand their requirements, and manage expectations. In partnership with the Project Manager, keep them informed about project progress, risks, and any changes in scope by providing or contributing to weekly status reports, using client-specific or standardized fme templates. Risk Management: Identify and mitigate technical risks, challenges, and potential roadblocks, proactively communicating them to the Project Manager. Collaborate with the technical project team to gather detailed information and explore solution options for addressing these risks. Change Management: Identify potential change orders and proactively communicate them to the Project Manager. Provide detailed technical scope definitions, estimates, and resource planning for the proposed changes. Quality Assurance: Ensure the team adheres to quality assurance practices by working closely with QA teams to define test strategies, review test plans, and ensure adequate test coverage. Provide support in identifying and resolving defects and performance issues. Continuous Improvement: Stay updated with the latest industry trends, technologies, and best practices and identify areas of improvement in internal processes, tools, or implementation and migration practices as well as opportunities for continuous learning and professional development within the technical project team. Thought Leadership: Stay abreast of industry trends, emerging technologies, and market developments, and share knowledge and insights through whitepapers, blog posts, webinars, or speaking engagements. Pre-sales Support: Support the business development and account management teams by providing technical expertise during the pre-sales phase. Collaborate with these teams to understand client requirements, develop tailored solutions and estimates, and contribute input to proposals. Education: Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field. Experience: Minimum of 8 years of experience in data and document migration, with at least 3 years in a leadership role within the life sciences industry. Technical Skills: Advanced experience in Veeva Vault RIM, data and document migration tools, SQL, XML, and scripting languages. Experience with cloud-based solutions as well as on-premise solutions. Regulatory Knowledge: Strong understanding of life sciences regulations and compliance requirements, including experience with validation processes as well as with GxP-validated systems, processes, and documentation requirements. This is a REMOTE position but may require occasional international and domestic travel to project sites or client meetings. Flexible work hours may be necessary to accommodate program timelines and deadlines Additional Skills & Competencies Leadership Abilities: Proven track record of leading technical teams and managing complex projects, with excellent problem-solving and decision-making skills. Problem-Solving and Prioritization Skills: Strong critical thinking, analytical, problem-solving, and conflict-resolution skills, with a client-focused approach, along with the ability to multitask and prioritize effectively in a fast-paced environment. Communication: Strong verbal and written communication skills, with the ability to effectively convey technical concepts to non-technical stakeholders and build strong relationships with both internal and external teams. Proven consultative skills with a track record of effectively guiding clients. Globalization: Experience working with clients across international markets. Demonstrated success in managing globally distributed technical project teams, including collaboration with offshore resources and external providers. The candidate must be strong at communicating with stakeholders of all levels. Must possess extensive interpersonal skills and must be able to prepare regular written and verbal presentations, technical documents, and reports The candidate must be self-driven but must also work well in a team, taking on different roles as needed (dependent on the project situation) The candidate must be flexible and able to multi-task; can work within an ambiguous, fast-paced environment, while also driving toward clarity and solutions; demonstrated resourcefulness in setting priorities Medical, Dental & Vision plans 401k with company match Life Insurance, Short & Long-term Disability Plans Paid Time Off (Vacation, Sick/Personal & Paid Holidays) Employee Referral Program Training & Development & Company Retreats Wellness Resources/Employee Assistance Program #LI-REMOTE

Lead and manage business analysis activities for Life Sciences projects, including process analysis, requirements gathering, content and data mapping, and supporting migration and change management. | Minimum of 10 years of business/process analysis experience, with technical skills in content management systems like Documentum, Veeva Vault, or Generis, and project management expertise. | 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: The Business Analyst role at fme, 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. 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. 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 #LI-REMOTE

Lead and manage business analysis activities for Life Sciences projects, including process analysis, requirements gathering, content/data mapping, and supporting migration and change management. | Minimum of 10 years in business/process analysis within information management consulting, experience with validated systems, project management skills, and technical knowledge of content management platforms. | 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: The Business Analyst role at fme, 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. 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. • 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 #LI-REMOTE