This job has expired

Sr. Clinical Supplies Specialist

Employer
GSK
Location
Richmond, VA, Virginia
Salary
Competitive
Closing date
Sep 21, 2021

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Sector
Pharmaceutical, Physicians/Nurses
Jobseeker Type
Professional
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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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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