Overview
fme Life Sciences focuses on Business Solution technology implementations that leverage Content Services (Document Management) platforms for clients in the Life Sciences Industry. The company is 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 leading Business Solutions and ECM vendors supporting the Life Sciences Industry, including Veeva, OpenText/Documentum, Generis (Cara), Sparta. fme is focused on client satisfaction and helping clients deploy mission-critical technologies through business process consulting, technology platform implementations and managed services, as well as data/document migration services.
Job Description
We are seeking a highly skilled and experienced Senior Technical Lead to oversee and drive data and document migration projects, along with enterprise content management (ECM) implementations. This role requires deep technical expertise, strong leadership abilities, and a thorough understanding of the life sciences landscape. The Senior Technical Lead 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 with leading content management platforms and the Life Sciences industry, and will collaborate with business and IT teams within Clinical, Regulatory, or Quality domains. The role involves implementing and migrating Content Management solutions 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 system requirements, and lead the successful implementation and migration of solutions. This role involves coordinating with an offshore team and partners to ensure seamless execution. A strong understanding of pharmaceutical validation, documentation practices, and relevant regulations is essential. Excellent verbal and written communication skills are required to engage effectively with individuals at all levels of an organization.
Key Responsibilities
- 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 architecture and design decisions, code reviews, documentation practices, project execution standards, and best practices. 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. Keep them informed about project progress, risks, and changes in scope by contributing to weekly status reports using client-specific or standardized fm e templates.
- Risk Management: Identify and mitigate technical risks, challenges, and roadblocks, proactively communicating them to the Project Manager. Collaborate with the technical project team to gather detailed information and explore solution options.
- Change Management: Identify potential change orders and communicate them to the Project Manager. Provide detailed technical scope definitions, estimates, and resource planning for proposed changes.
- Quality Assurance: Ensure the team adheres to quality assurance practices by working with QA teams to define test strategies, review test plans, and ensure adequate test coverage. Support defect and performance issue resolution.
- Continuous Improvement: Stay updated with industry trends, technologies, and best practices, and identify areas for internal process improvement as well as opportunities for continuous learning within the technical project team.
- Thought Leadership: Stay informed about industry trends and share knowledge through whitepapers, blog posts, webinars, or speaking engagements.
- Pre-sales Support: Provide technical expertise during the pre-sales phase to support business development and account management teams, helping translate client requirements into tailored solutions and estimates.
Requirements
- Education: Bachelors degree in Computer Science, Information Technology, Life Sciences, or a related field
- Experience: Minimum of 8 years in data and document migration, ECM implementation, or related fields, with at least 3 years in a leadership role within the life sciences industry. Extensive experience in architecting, implementing, configuring, and troubleshooting ECM systems and applications.
- Technical Skills: Advanced experience in ECM platforms (e.g., Veeva Vault, OpenText Documentum, Generis CARA), data and document migration tools, SQL, XML, and scripting languages. Experience with cloud-based and on-premise solutions.
- Regulatory Knowledge: Strong understanding of life sciences regulations and compliance requirements, including validation processes and GxP-validated systems, processes, and documentation requirements.
- Travel: 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
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