Clinical Supplies Manager, Logistics (Responsible Pharmacist) at PPD

The Role

PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
We have a new vacancy based at our Johannesburg office for a Manager, Logistics Responsible Pharmacist) in our Global Clinical Supplies team.
Responsibilities

• Manages local/in country Clinical Supply staff, facilities, and third party service providers required to support the conduct of clinical trials across the country of responsibility.
• Requires the management and assurance of local and global regulatory compliance requirements pertaining to the activities surrounding the import & export, receipt, storage, and distribution of all investigational products, comparator medications, diagnostics, medical devices and ancillary supplies.
• In some countries, depending on the facility's license, packaging & labelling responsibilities are required.
• Serves as main point of contact regarding clinical supply issues within country(s) of responsibility in connection with: current projects, future projects and any PPD owned activities.
• Identifies and manages all third party providers (Vendors, Depots, and Custom Brokers).

Education And Experience

• Bachelor's degree in Pharmacy or equivalent country health discipline and/or Logistic/Foreign Trade degree or equivalent.
• 3-6 years within Pharmaceutical Industry.
• 4+ years clinical supplies operations experience and 3rd party vendor management experience.
• GMP, GDP, GCP, and ICH knowledge and experience essential.
• Knowledge of packaging and labelling processes
• Deep knowledge of both local and global regulations covering all kind of Import and Exports activities is essential.

Knowledge, Skills and Abilities:

• Direct experience with the clinical supply operations, including: Facility maintenance and certification.
• Manufacturing, Packaging, Labelling and Auditing.
• Inventory planning and storage.
• Distribution and delivery planning.
• Returns and Reconciliation planning
• Destruction scheduling, authorization and tracking.
• Effective Management of Vendors: Depots, Waste Disposal Sites, Custom Brokers, International Forwarders and Couriers.
• Import and export planning -development-execution.
• Deep knowledge of International Trade Agreements as long as to keep a tight tracking of all regulatory changes concerning Import and Exports activities.
• Maintenance of Import and Exports Files according to PPD requirements, Client requirements and applicable Regulations.
• Ability to design, present, and implement specific plans to ensure high quality products and service and to ensure that all tasks maintain defined timelines to meet the goals of the study.
• Excellent interpersonal skills and problem solving/decision making skills.
• Demonstrate effective leadership and team building skills. Identifying, Hiring, and Maintaining Staff.
• Strong organizational skills required.
• Ability to travel to client/ management meetings on an occasional basis required.
• Very strong communication skills both written and verbal.
• Strong English Command is a must.
• Strong computer skills: working knowledge of Microsoft Project, Excel, and Microsoft Word is required.