TMF & RIM Business Process Subject Matter Expert (SME)

This is a 1099 position with no benefits.

This is a remote role with occasional travel to New Jersey.

Position Overview

We are seeking a Subject Matter Expert (SME) in Clinical (TMF) and Regulatory (RIM) domains to strengthen our life sciences capability portfolio. This role will focus on assessing, designing, and optimizing business processes and workflows within TMF and RIM functional areas.

The SME will collaborate with internal stakeholders and client teams to define best practices, identify gaps, and support the development of future project opportunities across Clinical and Regulatory systems. This position bridges functional domain knowledge with business process consulting, ensuring alignment between clinical operations, regulatory affairs, quality, and IT infrastructure teams.

Key Responsibilities

Business Process & Workflow Design

• Analyze current-state TMF and RIM processes across client organizations.
• Define future-state workflows, governance models, and process maps aligned with industry standards (DIA TMF Reference Model, IDMP, eCTD).
• Develop recommendations for system enablement, metadata structures, and data flow between eTMF, RIM, and Quality systems.
• Partner with stakeholders to create business use cases, requirements, and SOP frameworks that can be leveraged for future technology implementation projects.

Domain Expertise

• Provide deep functional knowledge of TMF lifecycle management (setup, conduct, closeout, archival) and RIM lifecycle management (submission planning, registration tracking, labeling, compliance).
• Advise on inspection-readiness strategies, document control best practices, and regulatory data management.
• Support evaluation of TMF/RIM technologies (e.g., Veeva Vault, ArisGlobal, Ennov, MasterControl, etc.) for fit-to-process alignment.

Cross-Functional Collaboration

• Work closely with Quality, Infrastructure, and IT teams to ensure process designs integrate with existing system landscape.
• Partner with Business Development and Delivery teams to define project scopes, proposals, and roadmaps for TMF/RIM initiatives.
• Contribute subject matter input to client workshops, capability presentations, and project governance forums.

Strategic Enablement

• Identify opportunities for continuous improvement, automation, and harmonization across Clinical and Regulatory operations.
• Stay current on regulatory trends, emerging standards (IDMP, ISO 27953, SPOR), and best practices in digital transformation.
• Serve as a thought leader for TMF/RIM process maturity and digital enablement strategies.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Clinical Research, or related field (Master’s preferred).
• 8+ years of experience in life sciences, with strong exposure to TMF and RIM process design, optimization, or system implementations.
• Strong understanding of regulatory frameworks (ICH-GCP, GxP, eCTD, IDMP).
• Proven experience in business process analysis, workflow documentation, and cross-functional stakeholder engagement.
• Prior consulting, system implementation, or process improvement project experience strongly preferred.

Skills & Competencies

• Deep knowledge of TMF and RIM workflows and supporting technologies.
• Strong analytical and process mapping skills (e.g., Visio, Lucidchart, BPMN).
• Ability to bridge technical and business perspectives.
• Excellent communication and client-facing consulting skills.
• Comfortable facilitating workshops, interviews, and process assessments.

Preferred Certifications

• Veeva Vault (RIM or eTMF) Certified Administrator
• Regulatory Affairs Certification (RAC)
• Lean Six Sigma Green Belt or similar

Engagement Outcomes / Success Indicators

• Defined TMF/RIM future-state process maps and gap analyses.
• Recommendations for system enhancements or implementations.
• Increased client confidence in Medvacon’s Clinical & Regulatory capabilities.
• Foundation established for future project delivery in TMF/RIM domains.

Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to [email protected].