Clinical Supplies Specialist
Proclinical is currently recruiting for a Clinical Supplies Specialist with a medical device company located in Westpoint, PA. Responsible for independently coordinating all activities associated with timely packaging, labeling and assembly of clinical materials for designated domestic and international studies in accordance with applicable safety and regulatory requirements as well as company policies. This individual is responsible for timely execution of clinical supplies activities including but are not limited to the processing of study specific packaging and labeling documentation, coordinate packaging job progress and review of documentation and procedures.
- Provides input and partners with Supply Chain stakeholders to develop the packaging/labeling strategy for Clinical Supplies Specifications
- Ensures all clinical supplies are processed according to cGMPs and appropriate safety requirements to meet existing standards defined by the FDA and EU or other international regulatory agencies
- Fully familiar with the SAP system and skilled user of such application. Utilizes computerized inventory and other special applications and tools as necessary for production of all packaging and labeling documentation. Capable of running reports and ad hoc queries to support the business
- Be capable to act as an approver of packaging and/or labeling documentation
- Prepares and processes documentation in accordance with study requirements
- Ensures all processes are covered by Standard Operating Procedures through contributing to or authoring within their functional area
- Contributes to packaging, labeling and distribution strategy through participation in process and approval of proposals
- Analyzes and anticipates technical problems and obstacles as they relate to clinical supplies and participates in adjustment of logistics pertaining to drug supply. May involve liaison with other cross functional stakeholders
- Investigate and document deviations that may occur
- Could represent the Operations group on internal teams as appropriate. Will undertake specific projects within the group on an as-needed basis
Skills and Requirements:
- Bachelor's degree in life science, engineering or business (required) and at least 3 years' experience in the pharmaceutical industry, preferably in a clinical supply related area
- Must have at experience in Project Management (vendor managing, project managing or some sort of supply or operations management)
- Problem solving skills, including ability to think critically in addressing issues such as investigations and complaints
- Interpersonal skills in verbal and written communication, ability to negotiate, resolve conflicts and engage in decision making to partner and influence
- Excellent computer skills including Microsoft applications; SAP is highly desirable
- Proven organization skills
- Strong ability to multi-task
- Ability to follow Standard Operating Procedures (SOP's)
- Demonstrated high level of initiative and ability to function independently with minimal or no daily supervision
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Dominic Santoro at 215-531-5280 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.