General Purpose Of Role
Supports assigned clinical customer projects to ensure that project goals and objectives are accomplished within the prescribed time frame, budget, and in accordance with customer expectations. Diligently manages significant matters pertaining to assigned projects. This is a hybrid role.
Main Responsibilities
* Provide continuous support to Project Manager and team by being the daily point contact for day-to-day internal problem solving and trouble-shooting.
* Lead weekly customer calls and CPT meetings in the absence of the Project Manager.
* Create notes for weekly customer teleconference calls and internal CTP meetings.
* Create project-specific documentation including packaging specification, variable data form, sample shipment request forms, monthly finished goods inventories, logistic management document, returns accountability worksheet, and monthly distribution billing spreadsheets.
* Manage timing of internal processes to ensure timely receipt and release of bulk, project packaging components and shipping supplies.
* Communicate with customers and vendors to resolve missing or erroneous certificates and documentation related to receiving and QC release of bulk, packaging components and shipping supplies.
* Monitor and update scheduling liaison with production needs for the project.
* Create project-specific routings and bills of material.
* Work closely with internal groups and vendors to ensure project milestones are achieved, including labeling and component design and delivery and on-time shipments of order requests.
* Allocate lot-specific bulk and material to the work order (hard allocation).
* Resolve discrepancies on end-of-study returns with customers and sites.
* Create Inventory Disposition Report and forward to customer for destruction approval of returns, remaining finished goods and customer-owned inventories.
* Process monthly distribution invoices and record data in project-specific metrics.
* Resolve shipment delivery issues by working closely with the DSA group, carriers, customer and clinical sites.
* Act as the client advocate and secondary client communication point for clinical packaging, storage, and distribution for assigned projects.
* Act as backup Project Manager contact for internal communications and trouble-shooting.
* Maintain accountability for assigned project tasks using appropriate project planning tools.
* Host and manage customer visits at PCI.
* Train and onboard new employees within the same role, as requested.
* Maintain and update project plans and timelines as requested.
* Adhere to all PCI, cGMP and cGCP policies, procedures, rules and regulations applicable to assigned clinical projects.
Requirements & Qualifications
* GCSE Grade C and above in English, Science and Mathematics (or equivalent) is essential.
* Understanding of quality standards including GMP, GCP and GDP.
* Experience in providing administrative support.
* Clear and concise communication skills.
* Attention to detail.
* Proficiency in JD Edwards and MS Office packages.
* Excellent written and verbal communication; structures communication in a logical way.
* A Level /NVQ/HNC or equivalent in Applied/Life Sciences or Mathematics is desirable.
* Experience in a supportive role, preferably in the clinical supply field and a contract environment.
* Motivated, self-starter, able to work without supervision on own initiative but also a team player.
* Demonstrates determination to succeed and can "push" to make things happen.
* Ability to multi-task and handle tasks simultaneously while adjusting to changing priorities and requests.
Benefits
* Employer pension scheme (above statutory pension).
* Competitive salaries that reflect dedication and contributions.
* Generous annual leave: 25 days plus bank holidays.
* Family-friendly benefits designed to support family life.
* Employee referral scheme: receive £500 for successful referral.
* Staff engagement programs and long-service awards.
* Health and well-being support: generous sick pay, access to a 24/7 GP through the employee assistance program, mental health support, life assurance up to four times the annual salary.
* Cycle-to-work scheme.
* Development opportunities: training programs, coaching, LinkedIn Learning, further education options.
* PCI Cares platform: donate to vetted charities with company matching; 8 hours of paid volunteer time per year.
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 programmes, marketing approach, and workplace culture.
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