fme Life Sciences

Role Description As an experienced Principal Project Manager, you will lead the fme team on one or more designated projects to deliver work within the schedule and budget described in the agreed project Statement of Work (SOW). The selected candidate will follow fme processes and methodology regarding internal and external reporting pertaining to measuring project performance and client satisfaction. The role will require the day-to-day management of select high-profile projects for key clients. The Principal Project Manager is directly responsible for end-to-end project management activities for assigned projects including, but not limited to: - Project status reporting (including financial KPIs) - Project planning - Risk identification, remediation, and tracking - Scope management - Estimation - Client and contractor management - Relationship management - Other project documentation preparation for projects of high business complexity The ideal candidate will have a high level of technical understanding of regulated systems in the life sciences industry, specifically Veeva RIM, as well as effective organization, leadership, and communication skills. Qualifications - Minimum of 15 years' experience as a Project Manager in the life sciences industry - Experience with business solution deployments leveraging enterprise content services platforms for clients - Experience delivering projects from a software or services provider or consulting firm experience highly preferred - PMP, PRINCE2, CSM certification - Experience with Veeva Vault RIM and regulated software migration projects - Effective interpersonal, communication, and presentation skills - Problem-solving and collaborative approach to projects - Self-motivated and directed - Bachelor's Degree in a related field required Requirements - 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: Leading client-facing meetings with technical lead support as well as holding 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 - Stakeholder Management: Serve as the primary point of contact for project stakeholders, including senior management (client and fme), client project management, and external partners - Risk Management: Identify and mitigate risks and issues that may impact project delivery - Quality Assurance: Adheres to ISO 9001 quality standard and processes and confirms 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 changes to project scope, schedule, and budget 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 - Remote Travel This role typically operates remotely but will also require travel to project sites, as needed, and occasional international and domestic travel for fme meetings. Flexible work hours are necessary to accommodate program timelines and deadlines. Location This is a remote based position with location requirements of New Jersey, eastern Pennsylvania, New York, Connecticut, Rhode Island, or Massachusetts. Language Requirements Business fluent-level English proficiency (spoken and written) is required.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description fme Life Sciences is seeking a highly experienced Global Solution Architect to serve as a Subject Matter Expert (SME) in regulated data management and content migration, as part of a client’s digital transformation process. This is a senior role in our organization and is ideal for professionals with deep domain knowledge in life sciences, a client-first mindset, strong technical proficiency, and a track record of designing scalable, compliant migration solutions. This position emphasizes strategic thinking, cross-functional collaboration, and dedication to delivering impactful results in global transformation initiatives for top-tier pharmaceutical leaders. This role will play a dual function, contributing to strategic sales efforts and providing subject matter expertise and executive technical oversight of active projects. Key Responsibilities - Subject Matter Expertise - Serve as a trusted expert in regulated data and content management with a focus on GxP, regulatory, clinical, and quality domains. - Provide insight into the enterprise architecture and deployment of systems such as Veeva Vault, OpenText Documentum, Generis CARA, etc. - Leverage deep industry knowledge to define proven best practices in content and data migration and compliance validation. - Business Development and Client Advocacy - Partner with Account Managers and Client Engagement Managers to create client-tailored strategic migration roadmaps and drive value in pre-sales engagements. - Lead client-facing pre-sales workshops to assess readiness, gather requirements, and advise future-state architectures for effective data and content migrations. - Represent fme in strategic client conversations, aligning technical migration direction with business transformation goals. - Technical Solution Design - Architect end-to-end migration frameworks, including advising on known source system and target system limitations and best practice approaches. - Lead solutioning efforts leveraging fme migration-center, proprietary accelerators, and client infrastructure. - Contribute to, review, and approve all solution estimates and proposals. - Advise on scalable, validated, and compliant architecture aligned with 21 CFR Part 11, Annex 11, and related frameworks. Qualifications - 20+ years of experience in enterprise data and content management platforms within the life sciences industry. - Strong domain expertise with content and data migration in validated environments, including systems like Veeva Vault and OpenText Documentum. - Demonstrated ability to bridge business objectives and technical solutions, especially in regulated domains. - Experience in consulting or client advisory roles with a focus on digital transformation. - Excellent communication, presentation, and executive briefing skills. Preferred Attributes - Experience with fme migration-center or other enterprise migration/ETL platforms. - Exposure to emerging technologies such as AI-enabled content analysis, metadata enrichment, or automation in migration pipelines. - Background in Computer Science, Life Sciences, Engineering, or related fields. - Familiarity with change management and user adoption strategies in regulated industries. 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 - Remote

Role Description The Business Analyst role at fme involves driving 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 - Driving user adoption through training and change management activities - Documenting content and data migration transformation mapping rules - Supporting validation and user acceptance testing (UAT) Qualifications - 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 - Experience in Regulatory Information Management (RIM) is preferred - Bachelor's Degree in a related field - Certifications on leading R&D technology platforms are a plus but not required Requirements - Superior conceptual thinking, analytical, and problem-solving skills - Strong verbal and written communication skills at all levels - Strong decision-making, judgment, and analytical skills - Proven ability to collaborate effectively with cross-functional virtual teams - Ability to travel to client sites across the US and potentially internationally when necessary - Experience with Documentum/Generis/Veeva Vault/IT and/or migration projects REQUIRED - Effective interpersonal, communication, and presentation skills - Collaborative approach to problem-solving - Self-motivated and directed 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