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Title : NVG- Senior Drug Supply Manager -202
State : New Jersey   Date : Aug 5, 2020
Experience Level :  
Position Type : Senior Drug Supply Manager      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: East Hanover, NJ

Job Title: Senior Drug Supply Manager

Duration: 6+ months (extendable) contract on W2


Position Summary: 

Optimize the strategy for clinical supply packaging and labeling design, and manage contracted activities to assure delivery of on time, quality clinical finished goods (Ph I-IV) according to GMP, through effective supplier relationship, project management and performance management. These activities are performed by DSM at approved, Quality Assurance contractors in cooperation with other internal line functions. 

Responsibilities: 

Primary liaison with contractors for external packaging, labeling and distribution strategy campaigns. 
Manages all finance activities, including Request for Proposal (RFP) for bidding & vendor selection, Purchase Orders (PO) and invoice approval. 
Manage all packaging activities, including Work Order (WO) creation, review & approval of contractor packaging records and monitoring in-process/on-going work at contractors. 
Packaging design optimization; works with clinical team to advise on and challenge protocol aspects related to complex packaging design. 
Provides supporting documentation for internal and external audits with and GCP QA (where applicable) to assess contractor capabilities. 
Provides supporting documentation for internal and external audits with local Compliance teams. 
Organizes and coordinates the shipment of drug product and packaging material to contractors. 
Responsible for materials and inventory management of all drug product, components and labels at the contractors. 
Establishes and manages supply related timelines with other groups as GDD-Global Clinical Supplies, NC QA, GMA, and PHAD to ensure agreed timelines are met. 
Authorizes destruction of outdated material with packaging vendor. 
Drives and contribute to process improvement activities within USCDMA and other internal departments. 
Conducts monthly supply meetings, proactively negotiates and communicates clinical supply plan/timeline to internal and external customers and partners. 
Reviews clinical trial protocol and provides input to drug sections as necessary. Develops strategic planning for packaging design according to the clinical protocol, which ensures optimized supply plan in terms of cost, feasibility and overage. 
Reviews and provides input to the program forecasts provided from the clinical team. Prepares and communicates monthly demand plans to GDD-Global Clinical Supplies to ensure timely for drug product strategic distribution planning. 
Initiates label design process, leads packaging design and optimization, coordinates the randomization and distribution of clinical supplies according to study design. 
Plans budget for associated external costs for packaging, labeling and distribution. Maintains program budget accordingly. 
Accountable for creating eCPRs with good quality (FTR), ensures that key study milestones are met.

Skills: 

Fluent English (oral and written) required; fluent in site-language desirable. 
At least 4 years of relevant experience in Pharmaceutical Development, Clinical Development, Clinical Supply Operations, Project Management or Related Field. 
Excellent organization, planning skills and leadership skills. 
Excellent communication, negotiation and interpersonal skills. 
Ability to strategically plan, organize and manage multiple projects simultaneously. 
Recognized knowledge of clinical supplies or relevant pharma industry experience. 
Successfully demonstrates track record of creativity and problem solving in projects. 
Demonstrates working knowledge of clinical supply systems and specialized tools. 
Advanced knowledge of development activities and processes. 
Advanced project management skills. 
Advanced presentation skills. 
Ability to work in interdisciplinary teams.

Education: Degree in scientific or relevant discipline (BS or equivalent). 


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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3 
Princeton , NJ 08540 
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