Senior Principal Clinical Supply Specialist
- Job Locations(All) | US-Remote
- ID: 2019-53856
We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you’re ready to be a part of something inspiring join us and Discover Your PRA.
Who are we?
We Are PRA.
We are 16,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Who are you?
- You have a strong attention to detail, excellent forecasting skills, and great time management skills.
- You are innovative and flexible and can multi-task with ease in a fast-paced environment.
- You are proactive and can solve potential problems with effective communication and team collaboration.
- You aim to produce the highest quality work, while maintaining professionalism, and courteous attitude with clients and our fellow team members.
What will you be doing?
- Generates initial and revises drug forecast at study and program level, communicating demand requirements to CMC and other stakeholders.
- Coordinates the procurement activities for comparator and NIMP and/or ancillary supplies.
- Interprets relevant protocol information to develop packaging/labeling design for clinical supplies
- Establishes distribution strategy and manages packaging/distribution timelines.
- Supports design and set-up of IRT system
- Coordinates the origination, proofing and transition of clinical study labels
- Proactively communicates drug supply delivery timelines to appropriate stakeholders.
- Coordinates the required documentation and activities for import and export of clinical supplies.
- Monitors global inventory and proactively communicates with all stakeholders to ensure adequate quantity and timely delivery of clinical supplies throughout duration of a trial.
- Monitors and manages retest dating for assigned study supplies.
- Proactively identifies potential risks, provides migations plans, and resolves clinical supply issues and complaints.
- Provides information to support financial planning for global studies and monitors drug supply study budget
What do you need to have?
- In-depth knowledge of regulations governing investigational products, including GMP and ICH/GCP guidelines.
- Excellent experience and skills in the management of clinical supply chain logistics.
- Excellent communication, interpersonal, and time management skills.
- Ability to work autonomously under limited direction.
- Read write and speak fluent English
- Bachelor’s Degree in a health sciences or related field.
- 5+ years of relevant experience.
- Excellent written, oral communication and presentation skills; Proficient in Microsoft Excel, Access, and Word.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.