Highlights
Generates internal packaging and labeling bill of materials and productions orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects. Ensures regulatory and CGMP compliance of activities in assigned areas of responsibility, through monitoring and management of performance and reporting any deviations immediately to the appropriate management and Quality unit.
Numbers & Facts
| Location | New Brunswick, NJ |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Year Founded | 1999 |
| Website | http://www.eclaroit.com |
Description
Project Manager
Job Number: 26-04480
Job Number: 26-04480
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Project Manager for our client in New Brunswick, NJ.
ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- Supports delivery of clinical supplies through effective management of assigned projects.
- Manages multiple projects.
- Liaise with responsible Trial Supply on aspects of clinical supplies packaging and labelling design and study requirements.
- Ensures production schedules meet agreed upon on-time delivery date of finished supplies.
- Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects.
- Responsible for coordinating availability of all deliverables (e.g. drug product and components, randomization file and label text).
- Generates internal packaging and labeling bill of materials and productions orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects.
- Responsible for the creation and/or release of Bill of Materials and process orders in SAP for assigned projects, including relevant checks on order accuracy.
- Executes all required SAP transactions such as goods receipt and goods consumption.
- Assures Bill of Material structures are consistent with the requirements of Independent Requirement Order (IRO) and Packaging Specification (PS).
- Converts planned orders (print and production) into process orders completing all required user fields and adding long text as required. Executes TECO transaction on completed process orders.
- Compiles supporting documentation and delivers a body of evidence (batch records) that supports the release of finished supplies for clinical use.
- Liaises with Quality Assurance to secure release of finished supplies.
- Reviews and approves vendor generated label proofs, orders specifications and other related documents.
- Reviews and approves vendor generated production orders and other related documents (i.e. change orders).
- Ensures regulatory and CGMP compliance of activities in assigned areas of responsibility, through monitoring and management of performance and reporting any deviations immediately to the appropriate management and Quality unit.
- May enter change controls and deviations into quality management system and conduct investigations as assigned.
- Works cross-functionally with individuals and project teams in various areas.
- Identifies opportunities for improving business processes and/or participates on project teams that are focused on continuous improvement.
- Participates in assigned training including CGMP and safety training.
- Authors and reviews procedural documents.
Required Qualifications:
- Required Bachelors degree or equivalent in pharmacy, engineering, business or life sciences .
- 5- 7 years relevant experience in the pharmaceutical industry or related healthcare environment. Highly prefer in Clinical
- Demonstrates ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment.
- GMP and/or clinical trial experience highly preferred
- Strong project management skills.
- Possesses solid oral and written communication skills.
- Good decision making and organizational skills.
- Demonstrates ability to effectively communicate ideas and to influence others to achieve results.
- Knowledge of ERP/MRP systems and supply chain principles.
- Eager to learn and continuously improve.
If hired, you will enjoy the following ECLARO Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
If interested, you may contact:
Louise Luche
Louise.Luche@eclaro.com
212-804-7466
Louise Luche | LinkedIn
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.
About Company
Eclaro is a Business and Technology Consulting Firm that connects top talent with opportunities nationwide. We have direct access to Hiring Managers from leading Fortune 1000 organizations in almost every industry segment, with particular expertise in:
• Technology and Business Consulting
• Financial Services and Insurance
• Pharmaceuticals and Life Sciences
• Consumer Products, Public Sector, and Utilities
Eclaro provides fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including:
• Consulting
• Professional Hiring
• Global Integrated Delivery™
• Managed Services
Eclaro recruits and manages a staff of highly skilled individuals in an array of specialized disciplines enabling our clients to leverage new opportunities, respond to increased and changing demands, and increase their profitability.
Eclaro’s Management Team averages over 25 years of experience in partnering with clients in technical, corporate operations and human capital solutions. We hold ISO 9001:2008 certification and have achieved SOC 2 Type 2 certification in Security, Availability and Confidentiality. Eclaro’s decades of expertise and collaborative practice have proven that The Right People are The Answer.
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