Description

Please note that the requirements specified in this posting are the basic qualifications required for the Clinical Supplies Operations Specialiist; however, job title will be dependent on the candidate's level of experience in those requirements.
OBJECTIVE:

This position will support clinical trial material (CTM) packaging, labeling and distribution projects as needed, primarily for US Phase 1 and less complex Phase 2-4 trials In addition, this position will manage inventory at clinical supply packaging vendors.

ACCOUNTABILITIES:

* For assigned projects, oversee the coordination of the packaging, labeling and distribution of CTM with contract vendors, including serving as point of contact and resolution for all packaging issues.

* Manage vendor timeline communication and prioritization of packaging job operational activities including directing vendor activities regarding manual shipments.

* Serve as representative in plant to over see packaging operations, as needed

* Review preliminary and executed vendor packaging batch records resolving packaging process non-conformance issues, as needed, to ensure that there is not a delay in supply delivery.

* Assist with timeline driven execution of the label approval process, including routing of proofs and translations for approval by functional areas. Address and resolve discrepancies noted during this process.

* Enter CTM retest/expiration date information into date tracking system, to ensure protocol design needs are met.

* Review and assess records for completeness and accuracy, complete Certificate of Release for CTM and obtain QA approval of material.

* Create and organize documentation in CS packets for working files and subsequent archival.

* Perform final reconciliation of CTM, including communication with global depot representatives, as needed, and coordinate destruction activities.

* Maintain constant communication concerning CTM status with study team members and vendors.

* Track and maintain BA/BE samples, including annual review and assessment of samples that are eligible for destruction.

* Ensure samples are available for investigator meetings.

* Provide CS metrics, as required. Perform preliminary analysis, and report any outliers or trends to management.

* Analyze vendor reports and amend inventory tracker to provide biannual bulk inventory report to TPC Finance.

* Identify and manage packaging component inventory levels.

* Procure comparator or ancillary products from requests made by CS Strategy and PS CMC group for US and ex-US (Canada and Latin America) projects.

* Lead the inventory life cycle management process by managing the general inventory

* destruction process (unlabeled supplies and unused bulk inventory) to achieve reduction in storage costs.

* Lead the annual review of reserve samples stored at packaging vendors to determine samples eligible for destruction, and carryout destruction process.

* Develop and maintain annual US storage and destruction P.O.s.

* Manage quotes and invoices for Phase 1 packaging projects, and US storage and destruction, including maintenance and update of monthly storage tracking by compound spreadsheet analyzing quotes and corresponding invoices to budget/task order, and resolve any discrepancies identified including managing credits from vendors - for Phase 1, and US storage and destruction.

* Utilize SRM (Finance system) for invoice processing, invoice history and issue resolution for Phase 1, and US storage and destruction invoices.

* Serve as subject matter expert for CS documentation submission to ROC.

* Develop and implement functional SOPs/work instructions suggesting key redesign or functional area process improvement initiatives as required.

* Support department goals and non-compound initiatives.

Requirements

Please note that the requirements specified in this posting are the basic qualifications required for the Clinical Supplies Operations Specialiist; however, job title will be dependent on the candidate's level of experience in those requirements.

Education and Experience:
Required:

* Bachelors Degree in Pharmacy, Biology, Chemistry, Nursing or other health sciences

Preferred:

* At least 1 year experience in a GMP environment in Ramp;D in pharmaceutical industry

* At least 1 year experience with distribution of clinical supplies and inventory control

* Previous experience in the coordination of CTM with contract vendors

* Manufacturing/logistics experience

Competencies, Knowledge and Skills:

* Leadership - Acts proactively. Takes the initiative to resolve issues and make recommendations. Acts responsibly to earn the confidence, trust and respect of others.

* Teamwork/Collaboration - Builds strong relationships. Actively contributes to team goals. Maintains open lines of communication.

* Results Driven - Delivers on commitments. Sets challenging but realistic performance goals. Effectively handles multiple assignments and competing priorities by managing time effectively. Checks work for accuracy and completeness.

* Managing Change - Demonstrates resilience. Works productively in the face of changing priorities and work demands. Proactively offers ideas and suggestions. Readily adapts in response to change in the internal or external business environment.

* Business Acumen - Understands Takeda business. Follows all applicable laws and regulations and Takeda policies and procedures. Analyzes problems and issues from multiple perspectives.

* Self Awareness - Acts conscientiously. Listens carefully and non-defensively to feedback. Provides timely and constructive feedback to others. Demonstrates composure under trying circumstances.

* Technical/Functional Expertise - Applies skills. Keeps current on professional/technical information. Shares job knowledge with others. Possesses the knowledge to access needed resources in a multi-level, multi-function organization.

* Ability to review systems, processes and policies to ensure compliance with required cGXP's.

* Understands the clinical packaging and labeling process supporting Ramp;D in the U.S.

* Understands current good manufacturing practices (cGMP), and current good clinical practices (cGCP) as applicable to the packaging, labeling, and distribution of CTM.

Submit your resume and start a quality career with Takeda!

We are an equal opportunity employer.
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