SUMMARY/JOB PURPOSE:
The Clinical Supply Specialist is responsible for supporting multiple clinical programs working closely with the Clinical Supplies project leads. The selected candidate will independently coordinate clinical supply activities for clinical studies in support of development programs. The activities include review of clinical study protocols design of clinical labels preparation of packaging and labeling requests management of depot and site shipments monitoring study drug inventory levels and assist in supply planning and forecasting.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Assist with planning and execution of clinical packaging projects including oversight of CMO scheduling production of labels and packaging of clinical trial supplies
• Review clinical trial protocols and understand impact on supply
• Coordinate and track drug shipments
• Monitor inventory at depots sites and distribution points
• Perform drug accountability with depots/clinical sites and Sponsor inventories
• Act as point of contact for third party storage distribution and packaging vendors
• Maintain traceable documentation to support GXP activities
• Has the potential opportunity to manage clinical projects
• Partner with key stakeholders including Quality Assurance and Regulatory Affairs to ensure supplies are labelled and released for clinical site shipment for global clinical trials.
• Design and/or review label text to meet product requirements and ensure compliance with US and international regulations.
• Represent clinical supplies function at clinical trial team meetings communicate plan and timelines to internal and external customers and partners.
• Utilize appropriate software and IT systems to effectively manage key project activities.
SUPERVISORY RESPONSIBILITIES:
• None
EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and at least three years of related experience or
• MS/MA degree in related discipline and at least one year of related experience or
• Equivalent combination of education and experience.
• Certification in assigned areas is a plus.
Experience:
• Typically requires a minimum of seven years of related experience and/or combination of education and experience.
Knowledge/Skills/Abilities:
• Demonstrate experience with clinical supply management planning labeling packaging and distribution.
• Willingness to work in a fast paced evolving environment.
• Clinical Supply management experience using contract manufacturing companies strongly preferred.
• Knowledge of GMP batch record development review and approval processes. Knowledge of Interactive Voice/Web response systems for use in clinical studies.
• Working knowledge of regulations relating to clinical labeling packaging and distribution activities.
• Working knowledge of GMP/GCP/GLP regulations required.
• Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways.
• Excellent project management and communication skills.
JOB COMPLEXITY:
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercise judgment in selecting methods techniques and evaluation criteria for obtaining results.
• Networks with key contacts outside own area of expertise.
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].