Serves as core team member for clinical projects representing investigational materials and/or technical operations
Responsible for technical assessments, selection of contract packaging vendors to provide service for specific projects, review and approval of contracts, pack design, drug ordering, supply plan management for packaging and labelling activities conducted by clinical supply vendors and monitoring of budget
Participates in audits and monitoring of clinical supplies vendors
In conjunction with the clinical supply vendors and internal departments, coordinates QA/QP release of investigational materials to be used in global clinical trials
Reviews and approves IVRS specifications from investigational materials perspective
In conjunction with CRO and Regulatory, co-ordinates the design of clinical labels to meet protocol, FDA, EU and other country specific regulatory requirements
Writes or reviews the Study Medication Sections of the protocol and IND as required
In conjunction with clinical supply vendors, monitors Investigational Materials inventories and expiry/retest dates supplies
Trains investigators and CROs on protocol procedures related to Investigational materials
Creates, reviews, and revises Clinical Supply related SOPs as appropriate
Perform other duties as assigned

Clinical Supplies knowledge with comprehensive operational experience in R&D Clinical Supplies and related areas on a global level
Must possess advanced knowledge of project management, packaging, labelling and distribution of clinical studies
Knowledge of and excellent understanding of Good Manufacturing Practice (GMP) and other associated regulations, guidelines, and industry standards for clinical trials
B.S. Degree or related scientific discipline + 7 years pharmaceutical industry experience
Thorough understanding of the development and clinical supplies process
Ability to maintain accurate records and files in accordance with GMPs, SOPs, and other regulatory requirements
Experience with e-mail, Windows, word-processing, database, spreadsheet applications as well as Microsoft Project and PowerPoint

Top Employer Accreditation, demonstrating that we provide excellent people policies and practices
Competitive compensation package inclusive of annual discretionary bonus and stock options
Focus on career progression with growth and development opportunities
Emphasis on Health & Wellness programmes
100% paid medical insurance and Employee Assistance Programme
Life cover
Excellent employer-matched pension scheme with Viatris contributing up to 11%
2 paid volunteer days per year

Senior Manager, Clinical Supply Operations

Key skills