Specialist I, Clinical Supplies

Job Description Summary:

JOB SUMMARY

The Specialist I, Clinical Supplies contributes to the planning, monitoring and performance of activities related to the inventory management and distribution of Investigational Product (IP) in compliance with internal procedures, processes and GxP requirements.

The incumbent works closely and collaborates with PTC internal departments, third party vendors (including, but not limited to: Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and shipping agents) and clinical study site representatives to ensure the availability of Clinical Trial Material (CTM) at study sites globally. He/she is directly responsible for the execution, oversight and accuracy of the invoicing and purchase order processes related to CTM inventory management and distribution.

The Specialist I, Clinical Supplies adheres to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Under the supervision of a clinical supplies manager or other, similar leader, facilitates the supply and distribution of clinical material to investigators; interacts with third party vendors and internal customers to monitor progress and to troubleshoot when required.

• Monitors Interactive Response Technology (IRT) inventory, distribution activity of IP and return functionality of IP as applicable.

• Under the supervision of a clinical supplies manager or other, similar leader, facilitates transfer and reconciliation of returned clinical supply drug from investigational sites using the appropriate IRT service; interacts with third party vendors and internal customers to monitor progress and to troubleshoot as necessary.

• Maintains Clinical Supply investigator product (IP) regulatory documentation in an “audit-ready” state ensuring inclusion of essential documentation and archiving of interim working notes.

• Monitors Clinical Supply inventory levels; compares periodically to vendor inventory to ensure accuracy and that final product reconciliation is accurately completed.

• Coordinates label review and approvals, including obtaining translations for participating countries and the associated regulatory requirements; obtains cross functional and leadership approvals on the labels.

• Reviews and assists with the generation of user specifications for IRT and contributes to, or may perform, user acceptance testing.

• Interacts with CMOs and shipping agents to ensure the timely shipping and delivery of IP to clinical investigator sites; monitors the logistics activities associated with the international and domestic transportation and distribution of study IP. Assists with generation of import/export documentation and troubleshooting discrepancies to ensure efficient IP depot transfers.

• Assists with monitoring IP inventory and expiration dates across clinical investigator sites and depots. This includes monitoring Interactive Voice Response/Interactive Web Response (IVR/IWR) system inventory and reports at the clinical investigator site and depot level and maintaining IVR/IWR shipping, receiving and distribution reports, system alerts and notifications.

• Receives, processes and tracks IP shipment requests from Clinical Operations for clinical investigator sites. May involve working with the depots to resolve distribution-related challenges to ensure IP is delivered in a timely manner to global clinical investigator sites.

• Under the supervision of a clinical supplies manager or other, similar leader, processes and facilitates the resolution of complaints, incident reports and shipment queries received from PTC’s Clinical Development organization, clinical investigator sites, depots and couriers; reconciles returns and destructions at the site and depots; compiles End of Study accountability data from sites, depots and CROs.  

• Establishes collaborative working relationships with depot distribution personnel; attends weekly meetings with appropriate PTC Clinical Development staff members and CRO project management teams to respond to matters related to clinical supplies inventory and distribution.

• Assists with forecasting drug supply needs for global and domestic clinical studies; assists Clinical Supplies Lead to develop shipping plans and generate shipping schedules; receives and processes demand information from working team, depots and CROs to ensure that matters impacting distribution are addressed or escalated and the patients’ needs are met.

• Assists with the generation of documentation used to request purchase orders and organizes the files and invoices for Clinical Supplies projects

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• Bachelor’s degree and a minimum of 1 year of supply chain, logistics or manufacturing experience in a pharmaceutical, biotechnology, manufacturing or related environment OR high school diploma and 7 years of supply chain, logistics or manufacturing experience in a pharmaceutical, biotechnology, manufacturing, or related environment.

* Special knowledge or skills needed and/or licenses or certificates required.

• Applied experience supporting supply chain-related processes including inventory monitoring, purchase order requests, invoicing and shipping distribution.

• Demonstrated ability to establish and maintain effective working relationships with cross functional team, other internal team members and external vendors.

• Demonstrated attention to detail and the ability to ensure the completeness and accuracy of work products across multiple workstreams on a consistent basis.

• Demonstrated ability to proactively identify issues/challenges and apply critical thinking skills to propose solutions. This also includes demonstrated ability to quickly identify critical issues and ensure that these issues are brought to leadership’s attention in a timely and compliant manner.  

• Proficiency with Microsoft Office.

• Excellent verbal and written communication and skills.

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. 

• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. 

*Special knowledge or skills and/or licenses or certificates preferred.

• Working knowledge of Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations.

• Experience shipping clinical supplies to domestic or international locations including knowledge of the shipping documentation required for both.

* Travel requirements

• 0-10%

Expected Base Salary Range:

$69,000- $85,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long- term incentives. All eligible employees may also enroll in PTC's medical, dental, vision and retirement plans.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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