Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
This is a FULLY REMOTE opportunity:
- Act as Client advocate, assisting with drug supply management throughout the life of the study
- Work in an unblinded capacity with secure, confidential study information
- Provide input for protocol development and amendment as needed
- Interpret clinical protocol to determine drug and ancillary supply requirements, packaging / labeling design, and supply plan
- Coordinate with Client to generate Master English Label Text (MELT) if needed
- Collaborate with Client and other appropriate stakeholders to establish labeling strategy
- Build drug projections to create a Supply Plan based on finished goods demand and production plans for domestic and international studies, considering drug retest and expiration dating
- Collaborate with PCI Packaging Project Manager (PM) to establish a production schedule based on the study supply plan
- Review and approve packaging batch documentation (pre and post production) on behalf of blinded Client when requested
- Contribute to commercial comparator sourcing strategy when needed
- Support Interactive Response Technology (IRT) design, set up, and maintenance
- Participate in IRT Requirements gathering process and provide input for IRT specification documents
- Perform User Acceptance Testing (UAT) according to a testing protocol (if provided), with focus on functionality, transactions, and reports that relate to drug supply management
- Release drug supply in IRT system
- Collaborate with Client to establish site supply parameters
- Adjust re-supply strategies by assessing clinical protocol revisions and analyzing enrollment rates, inventory usage, and trends
- Consult with PCI Distribution Project Manager (DPM) to ensure depot strategy, logistics management documentation, and setup is complete and meets Client requirements
- Assist with Import / Export process
- Assist with Quality processes (e.g., gathering documentation for EU Qualified Person)
- Independently manage clinical supplies, including packaging design, and contingency planning for multiple and complex studies
- Identify, manage, and monitor inventory of all clinical trial materials (drug and ancillary supplies) at both the depot and site level
- Track shipments to depots and sites
- Proactively identify potential risks, provide recommendations, and resolve clinical supply issues and complaints
- Adjudicate temperature excursions when requested by Client
- Manage and track the SMART contract budget and initiate Change Orders as needed
- Provide information as requested to support Client financial planning for global studies
- Attend Client meetings as requested (e.g., CMC, CRO, Clinical Operations, IRT, etc.) to provide updates for clinical supply, proactively manage expectations regarding drug delivery timelines and ensure clear cross-functional communication
- Coordinate drug return, accountability, and destruction process
- Provide final drug accountability reports to Client
- This position may require extra hours and/or weekend work.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
- Attendance to work is an essential function of this position
- Performs other duties as assigned by Manager/Supervisor.
- Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.
- Basic Mathematical Skills
- Intermediate Computer Skills: Ability to perform more complex computer asks and has knowledge of various computer programs
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
- Clinical supply chain management at Sponsor company or Clinical Research Organization strongly preferred
- Ability to work within the Client’s team structures and processes
- Working knowledge of general project management process and tools
- Ability to influence others, resolve conflicts, and negotiation skills
- Ability to multi-task
- Strong organizational skills
#LI-SW1
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Skills Required
- Bachelor's degree in a related field and/or 5–10 years of related experience and/or training
- Basic mathematical skills
- Intermediate computer skills and knowledge of various computer programs
- Full professional proficiency in speaking, reading, and writing for professional needs
- Very high reasoning ability, including problem definition, data collection, fact establishment, conclusion drawing, and interpretation of technical instructions
- Clinical supply chain management experience at a sponsor company or clinical research organization
- Ability to work within client team structures and processes
- Working knowledge of general project management processes and tools
- Ability to influence others, resolve conflicts, and negotiate
- Ability to multitask
- Strong organizational skills
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
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Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
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Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
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Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
