Sr. Clinical Supplies Specialist

Richmond, VA
June 10 2021
Organization Type
Site Name: Richmond Sherwood Posted Date: Jun 10 2021 The Sr. Clinical Supplies Specialist role is to provide leadership and operational oversight for the label design, primary/ secondary packaging activities and distribution of human use supplies to support both the Clinical Study Program and non-clinical consumer/sensory studies in support of the global Consumer Health R&D categories. In this role you will be working with the Clinical Development sub-teams and with functional partners in R&D Categories, R&D QA, Sensory and Consumer Understanding, Regulatory and Marketing to agree product supply requirements and timings for human use study trials. Once strategy is agreed you will then be working with the internal GMP team members to ensure label printing, packaging and distribution is carried out on target for study start and supporting their activities as required. This role offers opportunities to build experience across the CHRD categories (Oral Care, Pain, Respiratory and Wellness) as well as responsibilities to manage study supply delivery across a global network of sites and through external vendors when needed. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Work across departmental boundaries as Clinical Supplies expert to build efficient and collaborative ways of working with partners in R&D Categories, Clinical Development, Quality, Global Development Operations, Regulatory Affairs and Marketing. Accountable, through Clinical Supplies team that clinical trials materials are sourced, labelled, packed and shipped following cGMP and compliant with ICH/GCP and FDA regulations, CH SOPs and international shipment regulations to meet category clinical plans Responsible for contributing into Clinical Protocols, creating Packaging and Labelling documentation for secondary packing activities and ensuring that the Clinical eTMF documentation is all uploaded and ready Leading label design and approval, packaging and distribution planning for Non-Clinical (Sensory, Home Use Tests, Trade Assessment) studies Operate and maintain packaging equipment in accordance with company procedures and regulatory guidelines Prepare release specifications, submit release testing samples, and compile study release dossiers to obtain certificates of analysis Support internal packaging operations when required as part of lean and flexible team Build and maintain partnerships with preferred 3rd party providers to ensure good working relationships to enable efficient outsourcing of clinical supply activities both domestically and internationally Responsible for contract documentation and management of budget for delivery of clinical trials supplies through 3rd party outsource providers Lead and support audits through GSK internal audit teams and external regulatory bodies, closing out audit actions as assigned to ensure departmental compliance Maintain compliance to internal procedures, update SOPs and WIs as per periodic review or driving changes to process, complete Management Monitoring Audits as per assigned schedule and champion compliance across team Lead continuous improvement initiatives internally and act as a team member on cross functional improvement initiatives with Global Development Operations, Clinical Development and other partners as required as part of integration and future spin of new CH business from GSK. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in Chemistry, Pharmaceutical Sciences or Pharmacy Experience: Bachelor's degree in sciences with 7 years of relevant experience or a MS degree with 4 years of relevant experience Experience within Clinical Supplies role with strong knowledge of global regulations in human use investigational products and application to clinical trials Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's Degree in Chemistry, Pharmaceutical Sciences or Pharmacy Strong project management with proven record of delivering multiple projects simultaneously ensuring correct prioritisation of work Able to work and develop relationships with business partners across departmental and geographical boundaries Ability to build relationships with outsource providers to ensure department can meet and match demand for clinical study delivery Strong interpersonal skills, building and developing capability within others and acting as a leader and mentor. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. 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