Description
SUMMARY:This position assists in developing and implementing short term and long-term clinical supply chain strategies and networks to manage clinical supplies and their distribution whilst effectively managing challenges encountered within supply chain. S/he coordinates and ensures delivery of drug for clinical trials, procures bulk supplies and comparator product from outside vendors as needed, oversees appropriate labeling and packing activities, and facilitates the timely arrival of supplies at clinical sites.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Lead projects involving the planning, labeling, packaging and distribution of clinical supplies
* Responsible for project(s) trial supply strategies- US & Ex-US Phase I, II & III
* Responsible for all material deliverables as related to finished Clinical Supplies
* Works with management and internal stake holders to generate a clinical supply strategy and plan, to meet the required clinical demand
* Understands and works with the key related stakeholders involved in supply execution and both has knowledge of and acts within current GCPS, CFRS and regulatory requirements
* Responsible for contributing mentoring and helping in continuing the group's growth
SUPERVISORY RESPONSIBILITIES:
* May mentor and manage other team members
EDUCATION/EXPERIENCE/SKILLS:
Education:
* BS/BA degree in related discipline and eight years of related experience; or,
* MS/MA degree in related discipline and six years of related experience; or,
* Equivalent combination of education and experience.
* May require certification in assigned area.
Experience:
* Typically requires a minimum of 12 years of related experience and/or combination of experience and education/training.
* Experience in Biotech/Pharmaceutical industry required.
* Experience determining and testing IVRS requirements preferred.
Knowledge/Skills/Abilities:
* Knowledge of domestic and international shipping and logistics.
* Has extensive experience in relevant industry/profession and area of specialization.
* Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
* Identifies and implements methods and procedures to achieve results.
* Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
* Performs a variety of complicated tasks with a wide degree of creativity and latitude.
* Has complete understanding and wide application of technical principles, theories, concepts and techniques.
* Has good general knowledge of other related disciplines.
* Applies strong analytical and business communication skills.
Has extensive experience in creating clinical supply planning tools, and excels at using Microsoft programs and software
* Working knowledge of cGMP. CFR , GCP
JOB COMPLEXITY:
* Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
* Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
* Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
* Networks with key contacts outside own area of expertise.
To find out more about Real please visit www.realstaffing.com