Vendor Qualification Associate

3 weeks ago

San Mateo, United States Infotree Global Solutions Full time

Job Location: Foster City, CA or Santa Monica, CA, Seattle, WA

Top 3 Required Skill Sets: (1) R&D Clinical Procurement Experience (2) Candidates can be current or former project managers & (3) Deep understanding of Quality and Compliance across Pharmaceutical or Healthcare industries

Top 3 Nice to Have Skill Sets: (1) Vendor Qualification, (2) Vendor Outsourcing & (3) Vendor Contracting

Required Degree or Certification: BS or BA

The candidate should have a deep understanding of vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness activities as they will be leading and/or supporting those cross-functional efforts. The candidate should also have an understanding of various clinical trial activities such as clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.

Daily activities will include, but are not limited to, conducting Request for Information (RFI), Data Privacy and Security IT Assessments, Anti-Bribery and Anti-Corruption Due Diligence, Vendor Subcontractor Process Management, Financial Health Assessments, Inspection Readiness Preparation Activities, Data Analyses and Benchmarking to Provide Data Informed Insights into Strategies and Continuous Improvement Initiatives, Presentations, and Trainings.

The candidate should have executive presence, excellent communication skills, project management & critical thinking skills; and is comfortable interacting with internal stakeholders and external vendors. The Vendor Qualification Associate I will be regularly partnering with team members such as R&D Quality & Compliance, clinical operations, finance, legal, business conduct, vendor relationship management, payments, and vendors.

The Vendor Qualification Associate I is expected to complete tasks and projects under minimal supervision and has the ability to manage competing priorities effectively and proficiently.

Demonstrates a thorough knowledge of Good Clinical Practice GCP, Good Pharmacovigilance

Practices GVP, Good Laboratory Practice GLP, Good Documentation Practice GDP and ICH E6 R2 compliance requirements.

Demonstrates a thorough understanding of current global and regional trends in compliance. Candidate has 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA.(1) PMP certification or equivalent certification, (2) Candidates can be current or former project managers & (3) Project management experience in Pharmaceutical or Healthcare industries

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