Clinical Supply Operations Planner
Proclinical is currently recruiting for a Clinical Supply Operations Planner with our client located in West Point, PA and Rahway, NJ. Successful candidate will be 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.
- Provide input and partner with Supply Chain stakeholders to develop the packaging/labeling strategy for Clinical Supplies Specifications.
- Ensure 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.
- Utilize computerized inventory and other special applications and tools as necessary for production of all packaging and labeling documentation.
- Prepare and process documentation in accordance with study requirements.
- Ensure all processes are covered by Standard Operating Procedures through contributing to or authoring within their functional area.
- Contribute to packaging, labeling and distribution strategy through participation in process and approval of proposals.
- Analyze and anticipate technical problems and obstacles as they relate to clinical supplies and participate 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.
- Problem solving skills, including ability to think critically in addressing issues such as investigations and complaints.
- Be capable to act as an approver of packaging and/or labeling documentation.
- Capable of running reports and ad hoc queries to support the business.
- Fully familiar with the SAP system and skilled user of such application.
- 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.
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 call Samantha Reader at (+1) 267-983-0134 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.