Life Sciences R&D Consultant/Manager

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Bring your best skills forward to excel in the role:

• Deep understanding of Life Sciences/BioPharma R&D processes.
• Familiarity with clinical trial systems, regulatory submission tech, patient safety reporting platform, and any modern tech solutions to accelerate drug development.
• Strong stakeholder engagement and team leadership capabilities.
• Ability to develop strategic perspectives and thought leadership on industry trends, digital transformation, and innovation in R&D.
• Excellent communication, interpersonal, and analytical problem-solving skills

Key Responsibilities:

• Requirements gathering and defining acceptance criteria, to align with the organization's specific needs and business processes.
• Ensuring data integrity and efficient workflows.
• Ability to provide insightful, deal-relevant points of view and recommendations based on robust analysis.
• System documentation as per GxP-compliant SDLC process
• Deliver end-user support, training, and change management to ensure successful technology adoption.
• Monitor platform updates and manage system upgrades or enhancements as needed.
• Ensure alignment with industry best practices and regulatory expectations for technology enablement in R&D.

Read more about us:

• Recent Blogs

Job Location: Mexico City or Monterrey

Qualifications:

• Bachelor's degree mandatory. Desirable MBA or equivalent Masters degree in science, or a postgraduate degree with rich and relevant industry experience.
• 4+ years of progressive experience in the Life Sciences industry or consulting, ideally in roles involving business strategy systems implementation or technology transformation.
• Proven experience leading initiatives around Clinical trial systems, Regulatory submission tech, Patient safety reporting platform, and any modern tech solutions to accelerate Drug development space.
• In-depth understanding of Life Sciences R&D functions including Clinical Operations, Regulatory Affairs, Quality Assurance, Safety, and related compliance requirements (GxP, 21 CFR Part 11).
• Extensive knowledge and experience in agile methodology-based technology transformation projects.
• Demonstrated ability to manage multiple concurrent projects, prioritize tasks, and deliver outcomes in a fast-paced environment with multiple stakeholders.
• Proven ability to effectively plan, manage, and coordinate multiple projects in a dynamic environment with numerous and complex stakeholder groups.
• Excellent documentation skills and exposure to work within GxP-validated systems.
• Advanced English is mandatory.
• Availability to travel may be required.

Good to have:

Experience in at least 4-5 of the following areas:

• Clinical Trial Management Systems (CTMS)
• Regulatory Information Management (RIM)
• Electronic Trial Master File (eTMF) or Clinical Document Management
• Clinical Data Management / EDC
• Biostatistics or Clinical Data AnalyticsLaboratory Information Management Systems (LIMS)
• Quality Management Systems (QMS)
• Pharmacovigilance or Safety Systems

Additional Information:

Relocation Options: Candidates based in cities other than Mexico City or Monterrey can be considered, but Accenture regrets it does not cover relocation expenses for this position.

International Considerations: Foreign candidates can be considered but Accenture regrets that it is unable to sponsor employment Visas for this position.

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