OneTrust

Director, Submission Excellence – Technology Business Leader

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Beerse • Belgium

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Job Level

Senior

Tech Stack

PMP

About the role

  • Serving as strategic thought partner to SubX leadership on priorities, roadmap, operating model, and budget; translate strategy into executable plans and quarterly OKRs.
  • Standing up and running the SubX technology program office: governance cadence, meeting preparation, decision logs, action tracking to closure, and issue/risk management.
  • Establishing and monitoring progress toward multi-year SubX technology key deliverables; intervening to remove roadblocks and keep critical-path items on track.
  • Coordinating and consolidating business requirements for submission tools (e.g., biostats automation, document generation, QC/review, regulatory intelligence, publishing) and ensuring they are delivered into solution designs and releases.
  • Developing integrated, cross-functional plans spanning GRA, Medical Writing, Biostatistics, Regulatory Operations, Data Sciences, and JJT; aligning dependencies with other technology development programs.
  • Overseeing program portfolio, resources, and budget; supporting build/partner/buy evaluations and vendor management in partnership with Procurement and Finance.
  • Preparing executive-ready status, dashboards, investment cases, CARs, and leadership presentations; ensuring clear storytelling of value, risks, and decisions.
  • Leading change management and communications for SubX at the program layer; enabling initiative-level change/communications execution.
  • Driving process optimization and adoption of new digital workflows; defining success measures and monitor user experience, engagement, and compliance.
  • Ensuring alignment to standards and policies (e.g., eCTD, CDISC), responsible AI practices, and audit-ready documentation.
  • Acting as primary liaison to enabling functions (Finance, Procurement) to accelerate resourcing and contracting.
  • Coaching and developing a high-performing, diverse matrixed team (PMs, change partners, analysts, workstream leads); fostering an agile, learning culture.

Requirements

  • A minimum of a Bachelor's degree in a scientific, technical, IT or business related field is required.
  • 10+ years of overall work experience, including 6+ years in the pharmaceutical/healthcare industry is required.
  • A minimum of 6 years in a pharmaceutical/MedTech or comparable R&D area, with demonstrated organizational awareness and applied end-to-end (E2E) drug or medical device development knowledge is required.
  • A track record leading complex, cross-functional programs and managing multiple workstreams from inception through close-out is required.
  • Demonstrated ability to build cross-group plans, drive execution, and report progress; strong partner management and executive communication skills are required.
  • Experience coordinating business requirements into system design/development and releases in partnership with technology teams is required.
  • Experience in R&D operations or related fields; ability to influence senior leaders and key partners is preferred.
  • Certifications such as Six Sigma, LEAN, PMP and/or Agile; demonstrated process transformation and culture change leadership is preferred.
  • Experience with end-to-end process for operationalizing major regulatory submissions is preferred.
  • Experience with IT system design, development and implementation; vendor/SOW management is preferred.
Benefits
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
program managementcross-functional planningbusiness requirements coordinationsystem designprocess optimizationregulatory submissionsvendor managementdata scienceschange managementagile methodologies
Soft Skills
strategic thinkingexecutive communicationpartner managementcoachingleadershiporganizational awarenessstorytellinginfluencingproblem-solvingteam development
Certifications
Six SigmaLEANPMPAgile