Clinical Supply Project Manager (Packaging & Labeling) - Pharma (Hybrid– New Brunswick, NJ)

Stage 4 Solutions; New Brunswick (NJ); Ibrido; USD 69.000 - 77.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits

401K

Descrizione del lavoro

Stage 4 Solutions, Inc. is seeking a Clinical Supply Project Manager (Packaging & Labeling) for a 12-month hybrid role in New Brunswick, NJ. You will manage packaging/labeling activities, coordinate SAP BOMs, and ensure on-time delivery of clinical supplies.

This W2 position offers health benefits and a 401K. The role requires 5–7 years of pharma project management experience, GMP/clinical trial background, and SAP/MS Office expertise.

Competenze

• 5–7 years of project management experience in pharma or healthcare; GMP/clinical trial experience preferred.
• 3+ years in clinical trials or packaging/labeling.
• 3+ years with MS Office 365; SAP experience.
• Bachelor's degree or equivalent in pharmacy, engineering, business, or life sciences.

Mansioni

• Generates internal packaging and labeling bill of materials and production orders in SAP per trial design and regulatory requirements.
• Executes SAP transactions such as goods receipt and goods consumption; ensures BOM structures align with IRO and Packaging Specification.
• Reviews and approves vendor label proofs and production orders; manages change orders.
• Ensures CGMP compliance; monitors performance and reports deviations; participates in quality management activities.
• Works cross-functionally with project teams and drives continuous improvement.
• Participates in CGMP and safety training; authors and reviews procedural documents.

Conoscenze

Project management

GMP knowledge

Communication

Formazione

Bachelor's degree in pharmacy, engineering, business or life sciences

Strumenti

SAP

MS Office 365

Descrizione del lavoro

Clinical Supply Project Manager (Packaging & Labeling) - Pharma (Hybrid New Brunswick, NJ)

We are seeking a Clinical Supply Project Manager (Packaging & Labeling) for our global pharmaceutical client. The focus of the role is to support 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).

This is a 40-hour per-week, 12-month contract (extensions possible), 50% onsite at the client s office in New Brunswick, NJ.

This is a W2 role as a Stage 4 Solutions employee.

• Health benefits and a 401K are offered.

Responsibilities

• 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.

Requirements

• 5- 7 years project Management experience in the pharmaceutical industry or related healthcare environment. GMP and/or clinical trial experience highly preferred
• 3+years experience with clinical trial or packaging/labeling experience
• 3+ years with MS Office 365. Experience in ERP systems e.g. SAP
• Demonstrates ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment.
• Required Bachelors degree or equivalent in pharmacy, engineering, business or life sciences

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $50/hr. - $55.94/hr.