Kit Design Specialist

Job Summary The Clinical Trial Material Planning Specialist is responsible for creating from project scope, pricing and versioning all Bill of Materials for kit construction. The position is the liaison between Finance, Project Management, and the Supply teams. Essential Duties and Responsibilities Creating and Maintaining new Item Cards and Bill of Materials. Ensure item card is properly mapped to budget planning line items. Communicate with Clinical Trial Materials to ensure work instructions are complete and thorough. Assist Project Management teams to ensure Bill of Materials are created according to trial needs. Maintain version control on all BOM modifications and amendments. Work with inventory team to standardize SKU's on BOM's. Communicate with Supply team, Logistics and Project Management to ensure correct materials are used for international shipments. Execute corporate pricing strategy and submitting pricing for approval. Submit approved pricing to project management for sponsor approval Properly file and maintain pricing calculations for future review. Attend Project Management study kick off and handoff meetings. Support adhoc requests from other department: Finance, BOS, Contracts Perform various reporting as needed. Education/Experience Bachelor's degree from four-year college or university (preferred) or equivalent work experience. Candidates with High School Diploma/GED with 3 years' experience in a regulated environment. Candidates with 3 years' experience within a regulated environment preferred. Knowledge of ERP systems. Language Ability Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Math Ability Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Reasoning Ability Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Computer Skills To perform this job successfully, an individual should have a working knowledge of Microsoft Office applications including word processing and spreadsheets. Certificates and Licenses No certifications needed. Supervisory Responsibilities N/A Work Environment The noise level in the work environment is usually moderate. Physical Demands While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. This job description should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions and perform other related duties as may be required by their supervisor. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.