Summarized Purpose:

Manages the coordination of import and export activities for commercial products, ancillary supplies, investigational products and biological samples for assigned projects, ensuring that activities are in full compliance with company and client requirements and applicable local regulations.

Essential Functions:

• Develops an import/export plan for each assigned project and provides consultation on international requirements and customs.
• Meets with internal teams to coordinate efforts, provide recommendations and alerts, and update project reports/ spreadsheets. Ensures fluent communication and interaction between internal departments in order to avoid obstacles during the import/export process and ensure compliance with all applicable regulations.
• Integrates all import and export activities into the clinical supply chain to support project logistic strategy and compliance with internal policies.
• Participates in ongoing training on new regulations concerning both import/exports and GMP activities.
• Participates in process improvement initiatives.
• Participates in the bidding and/or bid defence opportunities regarding the addition of import/export services.

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Experience in the pharmaceutical, biotechnological, or CRO industry is preferred

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Solid understanding of import/export operations, planning and development
• Solid understanding of clinical supply operations, including: facility maintenance and certification, manufacturing, packaging, labeling and auditing, inventory planning and storage, distribution and delivery planning, returns and reconciliation planning, destruction scheduling, authorization and tracking, and vendor management (depots, waste disposal sites, customs brokers, international forwarders and couriers)
• Strong understanding of local and global regulations, including international trade agreements
• Basic understanding of drug formulation, analytical method development, stability, and bulk drug manufacturing practices
• Strong communication skills both written and verbal, including strong command of the English language
• Solid interpersonal skills and problem solving/decision making skills
• Strong computer skills including Microsoft Project, Excel, and Word
• Strong organizational and multi-tasking skills

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

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