Qualifications:

• MBA or equivalent Masters degree in science, or a postgraduate degree with rich and relevant industry experience.

• Consultant: 5+ years of progressive experience in the Life Sciences industry or consulting, ideally in roles involving business strategy systems implementation or technology transformation.

• Manager: 10+ 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 Analytics

Laboratory Information Management Systems (LIMS)

Quality Management Systems (QMS)

Pharmacovigilance or Safety Systems

Mexico City

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