Job Description

Job Tittle: Distribution Management Expert - Medical Supply

Duration: 24 Months

Location: Ridgefield, CT

Job Description-

The DM Expert independently directs the worldwide distribution of investigational medicinal products for the projects (IMP) and studies assigned in clinical studies of all phases. This includes independent development, planning, and optimization of the distribution strategy, as well as driving, controlling, and monitoring of external service providers (Distribution Partners/DP), even for highly complex and innovative study designs. Within the global IMP D Delivery (IMP D) Trial Team, the DM Expert is responsible for all distribution activities in terms of timelines, budget, risks, and optimizations. With profound expertise, the DM Expert acts as a consultant and contact person for colleagues and interfaces, represents DM in projects and committees, and represents the team leader, if necessary.

Accountabilities

• The DM Expert represents IMP D on the cross-division level in committees related to clinical development (One Medicine (OM)) and assumes responsibility for a specific field (e.g., import/export, temperature monitoring).
• He/she takes on cross-study tasks of vendor management.
• Acts as a mentor for new employees and represents the team leader.
• Evidence of contributions to projects.
• Vendor processes optimized.
• New employees are trained on schedule.
• Ownership of the DM team in global and local innovative and strategic projects, internal and external, as well as in continuous process improvement (CPI) projects.
• The DM Expert is responsible for optimizing and implementing OM relevant projects and is a consultant and main contact person for interfaces (e.g., CD&O).
• Proactive representation of the OM role in the project team and coordination of the content with the OM team.
• Demonstrated contributions to sub-teams and projects.
• The DM Expert is responsible for effective cooperation at the study level as the main contact partner of the external service provider. This also includes the independent evaluation and introduction of improved workflows and communication channels, implementation of new product categories with special requirements regarding the production of new products, storage/transport conditions, biosafety, medical devices, and where applicable, digitization projects.
• The DM Expert is the main contact for CD&O at the study level regarding distribution strategy and customs issues.
• Provides a wide range of knowledge and is recognized as an SME for distribution.
• Review cooperation with the supervisor and feedback of service provider or company or CD&O.
• Standalone negotiation, definition, control, and monitoring of schedules and activities with external distribution partners to ensure that all activities are completed at the agreed date with the required quality and that the IMP are available to treat patients at the agreed location on time.
• IMPs are delivered to clinical investigation centers in a timely manner and without critical deviations in the area of responsibility of the DM Expert.
• Independent preparation of an appropriate worldwide distribution strategy of IMP for implementation of the medical study design in compliance with regulatory, legal, customs, and product-specific requirements.
• The DM Expert also manages highly complex studies in a variable regulatory and customs environment independently.
• Independent creation, monitoring, and continuous adaptation of strategies and partners in relevant IT/IRT systems to ensure patient care.
• The DM Expert guides optimization of the distribution strategy in terms of total costs and risks.
• Specifications of the distribution strategy meet all requirements.
• IT/IRT specifications meet current study requirements; patient care is ensured.

Skills

Several years of experience in the pharmaceutical industry with a focus on international clinical IMPs supply, as well as a good understanding of the clinical development processes.

Very good understanding of product-specific properties and product quality.

In-depth knowledge of international regulatory, legal, and customs regulations and experience in the field of import/export.

Education

Bachelor's degree in science or distribution management with several years of experience in the pharmaceutical or similarly regulated industry in a relevant field.

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