Clinical Supply Manager

Overview

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Responsibilities

Job Purpose

Act as the investigational product supply (IPS) department point of contact with the clinical team to provide clinical supply management during the lifecycle of the clinical trial to meet business objectives and patient need.

KEY RESPONSIBILITIES/ACCOUNTABILITIES

The job holder is responsible for

Establishing effective working relationships with the clinical team to fully understand the needs for the clinical trial .

Responsible for ensuring effective delivery of supply management strategy in line with the clinical trial protocol for clinical trials.

Forecasting the materials required to meet the clinical trial supply requirements and feeding into demand planning.

Guiding the clinical team in the design of the clinical trial to ensure the appropriate flexibility and cost-effective options are explored and agreed .

Managing the supply of IMP to study sites against agreed timelines for the lifecycle of the clinical trial.

Managing the lnteractive Response Technology (IRT) system for IMP from set-up to close out of the clinical trial.

Reviewing the effectiveness of current processes and providing input into process improvements.

Maintaining cGxP and H&S knowledge applicable to the role.

DETAILED RESPONSIBILITIES/ACCOUNTABILITIES

Provides clinical supply management oversight during the lifecycle of clinical trials to meet business objectives and patient need by:

Reviewing the clinical protocol and attending appropriate kick-off meetings to guide the clinical team in the setup and planning of clinical supply material.

Planning clinical supply delivery against agreed timelines.

Generating appropriate documentation to enable the production and distribution of clinical supply material, including protocols and reports as required.

Setting up and managing clinical supply through the IRT system.

Ensuring that clinical supply material meets the necessary cGxP requirements.

Liaising with a variety of external stakeholders such as, Manufacturing, Regulatory, Clinical Coordination, Quality Control and Quality Assurance, to ensure clinical supply is maintained .

Facilitating the resolution or escalation of project issues.

Understands Home Office requirements with regards to the storage and distribution of IMPs containing controlled drug substances.

Ensures that the handling of product complaints is completed in a timely manner.

Provides input into SOP review and development.

Provides input/ leads departmental improvement projects as required.

Ensures all quality documents are completed within the required timeframe.

Ensures training and associated records are kept up to date.

Maintains and provides knowledge and expertise in clinical supply and keeps abreast of relevant new trends.

Executes additional tasks in order to meet departmental project-related or developmental/change objectives.

Carries out their work in a way that will not adversely affect their own, or others’, health, safety and security or the environment and reports any shortcomings in GW arrangements.

Ensures that activities under their control are carried out in ways to minimise risks to health, safety, security and the environment.

KEY ATTRIBUTES/SKILLS/EDUCATION - ESSENTIAL

Knowledge

Degree or experience in relevant discipline.

Appropriate scientific, operational and technical knowledge related to clinical supply.

Good understanding of IRT systems.

Excellent knowledge of Microsoft Office software.

Experience

A minimum of 2 years within a Clinical Trial Supply arena.

Principles of project management.

Working within a regulated environment (e.g. cGxP, ICH guidelines).

Skills

Excellent communication skills both written and presentational.

Excellent attention to detail.

Awareness of risk management principles.

Attributes and Behaviours

Develops and maintains positive working relationships with others.

Shares ideas and information.

Assists colleagues as and when required.

Demonstrates a ‘can do’ approach.

KEY ATTRIBUTES/SKILLS/EDUCATION – DESIRABLE

Higher qualifications (e.g. MSc/PhD) in relevant discipline.

Project or people management qualification.

Experience of clinical supply using Controlled Drugs (CD) and/or Cold Chain products.

Jazz Pharmaceuticals is an Equal Opportunity Employer.