Project Manager

Job Description

Job Summary:

• 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 Education:

• 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.

Required Skills:

• Demonstrates ability to plan, manage and execute multiple projects and to deliver a Products 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.

Must Haves:

• Required Bachelor’s degree.
• 3+ years’ experience in a GMP environment.
• 3+years’ experience with clinical trial or packaging/labeling experience.
• 3+ years with MS Office 365.
• Strong written communication skills.
• Experience in ERP systems e.g. SAP.