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Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

We have an exciting opportunity for a Strategy Lead to join our growing Pharmalex team within Cencora. This role is essential in providing Leadership to our evolving team in the US and internationally. This is a remote role based in the United States.

Responsibilities:

• Provide just-in-time guidance to study teams on key operating model processes and required documentation, prioritizing real-time inspection readiness
• Manage and guide teams on inspection readiness planning, including developing and maintaining inspection readiness plans and tools in collaboration with cQA and GCP Excellence in Clinical Trials leadership.
• Facilitate development of key inspection deliverables including but not limited to required listings, functional presentations, issue related storyboard development, and study team preparation for audits and inspections
• Action compliance monitoring signals and study health metrics with teams to mitigate real-time issues
• Engage appropriate Sponsor and CRO SMEs in inspection readiness activities and study-level risk assessment investigations
• Oversee and manage overall TMF performance and processes, including risk-based oversight strategies and adherence to TMF Plan and TMF Index, to ensure compliance and inspection readiness, including the cross-functional study team and outsourced elements to the CRO.

Work Experience:

• Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field
• Solid knowledge of and experience in GCP compliance, regulatory inspection readiness and study execution processes
• Experience with CROs and outsourced clinical trial activities, sponsor experience preferred
• Solid knowledge of drug development and clinical trial processes, including related standards and documents.
• Experience in clinical trials systems management and oversight (Veeva preferred)
• Proven awareness of sponsor oversight requirements and regulations
• Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.