Our Client, a Biopharmaceutical company, is looking for a Vendor Qualification Associate I for their Foster City, CA/Hybrid location.
Responsibilities:
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. PMP certification or equivalent certification, Project management experience in Pharmaceutical or Healthcare industries.
Requirements:
Strong interpersonal communication skills
Attention to detail and proactive management of quality findings will be integral to the team's success
Strong project management, organization, and critical thinking skills
Comfortable interacting with internal stakeholders and external vendors
Executive presence
Required Years of Experience: 3-5 years
R&D Clinical Procurement Experience
Candidates can be current or former project managers & Deep understanding of Quality and Compliance across Pharmaceutical or Healthcare industries and Excel
Vendor Outsourcing, Subcontractor Management, Vendor Contracting and System skills (Veeva, RDMS, TMF etc.)
Growth Mindset, Proactive Leader to drive initiatives, Strong written and Verbal Communication skills, Passionate, and Able to thrive in a dynamic work environment
Why Should You Apply?
Health Benefits
Referral Program
Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or expression, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.#J-18808-Ljbffr
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