Opella

Digital Lead – Medical, Regulatory Affairs, Pharmacovigilance Platforms

Opella

full-time

Posted on:

Location Type: Office

Location: BarcelonaSpain

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Job Level

About the role

  • Act as the pivotal link between the Global Science- Medical RA & PV functions, and technology providers.
  • Develop and execute a comprehensive digital strategy for Medical, RA, and PV platforms.
  • Lead discussions on technical feasibility, prototype development, and the design of technology solutions.
  • Build, mentor, and lead a team of digital experts focused on Medical, RA, and PV domains.
  • Manage the execution of the approved technology roadmap.
  • Drive the enhancement and optimization of digital platforms used in Medical Affairs, Regulatory Affairs, and pharmacovigilance.
  • Collaborate closely with relevant departments to align digital initiatives.
  • Supervise both daily and scheduled support for Medical RA & PV platforms.
  • Oversee relationships with technology vendors and service providers.
  • Ensure that relevant digital platforms and processes comply with all regulatory requirements.

Requirements

  • Bachelor’s degree in a relevant field; Master’s degree preferred.
  • Proven extensive experience in digital leadership roles within the Lifesciences or consumer healthcare industry.
  • Proven experience in overseeing and implementing digital systems like Medical Affairs event platforms, RIMS and publishing platforms and ARIS or similar PV Platforms.
  • Strong understanding of Medical affairs, Regulatory Affairs and PV processes.
  • Exceptional leadership and team management skills.
  • Excellent communication and stakeholder engagement abilities.
  • Demonstrated ability in evaluating, negotiating, and managing contracts and Statements of Work with Medical, RA and PV technology vendors and implementation/support providers.
  • Comprehensive knowledge of Quality Assurance and regulatory compliance, including 21 CFR Part 11 and FDA regulations.
  • Strong problem-solving capabilities and a track record of successful project delivery.
  • Advanced English required, Spanish or French preferred.
Benefits
  • Competitive salary
  • Flexible working hours
  • Professional development budget
  • Home office setup allowance
  • Global team events

Applicant Tracking System Keywords

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

Hard skills
digital strategy developmentprototype developmenttechnology solution designdigital platform optimizationcontract managementproject deliveryregulatory complianceQuality AssuranceMedical Affairs event platformsRIMS
Soft skills
leadershipteam managementcommunicationstakeholder engagementproblem-solving