TMF & RIM Business Process Subject Matter Expert (SME)Medvacon Life Sciences • Sparta, Tennessee, USA

TMF & RIM Business Process Subject Matter Expert (SME)

Medvacon Life Sciences • Sparta, Tennessee, USA

19 days ago

Job type

Full-time

Job description

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

Bachelors degree in Life Sciences Regulatory Affairs Clinical Research or related field (Masters 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 Medvacons 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 @. If you receive a message that seems suspicious or is not from our official domain please report it immediately to

Required Experience :

Senior IC

Key Skills

Databases,System Design,Cybersecurity,System Architecture,Intelligence Experience,Military Experience,Requirements Gathering,Joint Operations,Curriculum Development,DoD Experience,FISMA,Ant

Employment Type : Full-Time

Experience : years

Vacancy : 1

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Subject Matter • Sparta, Tennessee, USA

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