Senior Clinical Supplies Management - Remote
Apex Systems Inc.
Madison , NJ 07940
Posted 2 months ago
DescriptionPosition can be based in (NJ), (CA), (FL) or REMOTESummary:
Independently coordinates clinical supply activities for clinical studies in support of development programs.
These activities include review of clinical study protocols, design of clinical labels, preparation of packaging and labeling contracts, and forecasting and ordering supplies. Must coordinate the efforts of Clinical Trial Supplies Packaging with Clinical Supplies Manufacturing, Clinical Research, Pharmaceutical Development, Quality Assurance, and Regulatory Affairs with the objective of establishing a plan to have clinical supplies available within the agreed time frame.Responsibilities:
Develops and implements the initial timeline, budget, drug supply forecasts and component requirements needed for preparation of the Clinical Supply Master Plan for Phase I through IV clinical protocols Represent clinical supplies department at CMC/Clinical meetings to update and forecast the status of projects Reviews Clinical Research Development programs and coordinates development of yearly clinical supplies forecasts and supply plans Protocol interpretation and breakdown Demonstrates planning, project management, negotiation and presentation skills Monitor IP for duration of study and ensuring appropriate stock levels are available for study requirements.
Continue to monitor budget, depots and monitor IRT after study start. Ensure IP reconciliation is completed. Works on routine assignments, and applies knowledge and experience in learning new procedures Report and Protocol Writing: Create reports and documents to facilitate and record every aspect of the operations performed or projected Effective coordination of supply requirements for local and international studies, including continuous forecasting, communicating manufacturing needs, and scheduling of packaging/labelling activities
Bachelors Degree At least 6+ years of Clinical Supply / Clinical Packaging / Project Coordination experience in the pharmaceutical/device industry or CRO Knowledge cGMPs and relevant FDA Regulations essential Excellent communication and writing skills Proficiency in Microsoft Office and Microsoft Project#LI-KS1EEO EmployerApex is an Equal Employment Opportunity/Affirmative Action Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer.
We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.