Qureos Mentor

Parexel

<div>The Supplies &amp; Logistic Project Manager (SLPM) acts as functional leader and will provide global leadership, management, general oversight, and direction for Clinical Trial Supply &amp; Logistics (CTS&amp;L) projects. This requires in-depth business understanding to make effective decisions independently and the knowledge and experience to confidently recommend a course of action.
The SLPM leads the CTS&amp;L teams by combining a depth of clinical &amp; lab logistics experience with insight into client pressures and an ability to develop the right solution for the client to achieve operational excellence, delivery of projects/programs on time, to budget, to the highest quality and in compliance with ICH GCP, GCLP, customs regulations and GMP. The SLPM has overall accountability for the development and execution of the CTS&amp;L strategy and financial performance of the project.
May act as Project Leader for CTS&amp;L standalone projects or for projects involving a small number of services, where no other PAREXEL Project Leader is assigned. 
Key Accountabilities:
Project Management<ul><li>
Review and approve project scope, timelines, and budget for the contract development. Identify and communicate project deliverables to all stakeholders.</li><li>
Engage internal and external clients to develop logistics concepts and solutions to meet study deliverables, objectives and profitability while achieving client satisfaction.</li><li>
Ensure study/project timelines and budgets are met in accordance with the contractual agreement including proactive management and communication of timeline changes to ensure the efficiencies are maximized.</li><li>
Ensure that study specific management tools and documents are in place and constantly maintained.</li><li>
Review, overseeing and management of the resources assigned to the project to ensure the CTS&amp;L FTE assigned is appropriate and meeting the study&rsquo;s requirement.</li><li>
Initiate project related training for project team members including but not limited to CTS&amp;L staff.</li><li>
Perform risk assessment and develops mitigation/contingency plans as needed and manages project execution accordingly Prepare,participate in and follow up on audits/inspections.</li><li>
Undertake the full range of project-based duties relevant to the leadership, management, and development of the project team to ensure their performance meets and/or exceeds the requirements to be fulfilled both on the study as well as on a personal goals/objectives level</li></ul>
Operational Strategy and Execution<ul><li>
Develop &amp; manage execution of project or program related clinical supply, sourcing, manufacturing, distribution &amp; laboratory logistics strategy with relevant stakeholders in line with applicable regulations.</li><li>
Communicate with 3rd party providers and negotiates scope of work in conjunction with procurement.</li><li>
Utilize applicable tools for supply chain simulation and forecasting.</li><li>
Develop, plan, and manage inventory according to strategy, quantities and forecast.</li><li>
Develop supply schedule, seeks feedback from clinical team on study progress and adjust accordingly and provide feedback to depots.</li><li>
Lead formal hand over meeting with the Proposal Support</li><li>
Develop and implement production, depot and distribution strategy including collaborating with 3rd party depots with relevant stakeholders.</li><li>
Overview the operational management of programs and assets</li></ul>
Financial Management<ul><li>
Ensure study/project timelines and budgets are met in accordance to the contract agreement</li><li>
Finance and Profitability Management (Monthly, control, input) incl. client invoicing</li><li>
Maintain Parexel&rsquo;s Internal Project controlling/Financial systems including but not limited to monthly revenue and forecasting.</li><li>
Pass Thru Cost (PTC) management with controls and reporting of costs for internal service fees and external providers incl. invoicing.</li><li>
Gather feedback and evaluate on the projects status and identify for any potential CIS (Change in Scope) for professional and/or PTC needed in a timely manner to ensure that the operational tasks are contractually covered.</li><li>
Follow through on any CIS until signature.</li><li>
Monitors the projects status and identify for any potential Change in Scope (CIS) needed in a timely manner to ensure that the operational tasks are managed.</li><li>
Contributes to profitability/finance management (monthly reporting &amp; forecasting, budget control, change in scope management</li></ul>
Customer satisfaction and Client Liaison<ul><li>
Act as point of contact for internal and external customers and use a consultative approach in issue resolution.</li><li>
Proactively engage with external and internal clients in solution improvements</li><li>
Work towards establishing positive relationships with internal and external clients.</li><li>
If required actively take part in the bidding process (Proposal, 3rd Party Vendor Selection, Bid Defense, Contracts negotiation and review) including client presentations</li><li>
Represent Parexel at professional meetings/conferences as participant and/or speaker.</li><li>
Assist in managing increased demands and expectations of customers through consistency and predictability in internal procedures and avoidance of crisis situations</li></ul>
Ensure Quality and Process Improvement<ul><li>
Lead project meetings and support team members to monitor and ensure that projects is completed within budget, schedule and according to contract specifications in accordance to the quality standards, SOPs, ICH-GCP, GMP, GCLP, GDP and/or any other guidelines to fulfil local regulations, including customs regulations</li><li>
Support ongoing optimization of system infrastructure (systems used by CTS&amp;L such as IPTrack, LoMAS, processes, other internal tools) Implement process improvements, including CAPA, in conjunction with the team, in response to corporate, quality issues, client and team feedback and quality audits.</li><li>
Prepare, represent CTS&amp;L project team and follow up on audits/inspections</li><li>
Performs risk assessment and develops mitigation/contingency plans as needed and manages project execution accordingly.</li><li>
Ensure that study specific management tools and central file maintenance plan are in place.</li><li>
Initiate project related training for project team members and ensure project team members adheres to processes established</li></ul>
Skills:
<ul><li>Client focused approach to work</li><li>
A flexible attitude with respect to work assignments and new learning</li><li>
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.</li><li>
Operational leadership and project management skills</li><li>
Proven strong business and commercial acumen.</li><li>
Proven consultative selling and negotiation, communication, and customer management skills.</li><li>
Proven leadership and interpersonal skills</li><li>
Ability to Mentor, give work instructions, encourage, train and support team members.</li><li>
Ability to develop creative solutions for any Clinical Supply Chain aspect, incl. PLD services.</li><li>
Sound operational understanding of Clinical Studies and related Supply Chain aspects</li><li>
Global team management and development skills</li><li>
Self- Motivated with a professional attitude</li><li>
Capacity to work effectively in a matrix environment and value the importance of teamwork.</li><li>
Proficient use of MS office suite</li><li>
Willingness and ability to travel as required.</li><li>
Excellent interpersonal, verbal and written communication skills</li><li>
Good understanding of the GxP regulatory framework</li></ul>
Knowledge and Experience:<ul><li>
Excellent understanding of logistics operations</li><li>
Extensive experience of pharmaceutical/clinical research/consulting industry</li><li>
Profound experience in laboratory logistics and/or clinical supply chain management or related field within the biopharmaceutical industry</li><li>
Strong competencies in leading financial tasks such as budgeting, revenue recognition, change in scope analysis, cost negotiations, and financial metrics analysis.</li><li>
Project management and/or significant team leadership experience</li><li>
Individuals should have a strong understanding of cross functional activities.</li><li>
Profound multinational work experience</li><li>
Fluent in English</li></ul>
Education:
<ul><li>Educated to B.A/ B.S. or Master degree, or equivalent (e.g. Pharm. D.), in biology, pharmacy, or other health &ndash;related discipline, international trade, business administration or logistics or relevant work experience</li></ul> 
#LI-REMOTE</div>

Supply and Logistics Leader

<div>
 
 The Production Services Coordinator (PSC) Is Responsible For
 
 
 
 <ul>
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 The pre-production activities relating to batch documentation, labeling and GMP flow to ensure all production materials are produced to meet the timelines following SOPs, applicable ICH-GxP* and other applicable industry &amp; regulatory guidelines to meet or exceed client expectations.
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 Development and procurement of labels and secondary packaging materials
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 The PSC will also lead pre-production planning activities including:
 </li>
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 Coordination of SPARC meeting
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 Monitoring and management of pre-requisite materials required to enter production
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 Analysis and monitoring of data pertaining to shipment and packaging activities
 
 
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 </ul>
 The PSC is the link between PM&amp;D and PLD for pre-production on assigned projects.
 
 
 
 Key Accountabilities
 
 
 
 
 General
 
 
 
 <ul>
 <li>
 Coordinate delivery to meet the agreed production timelines
 </li>
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 Comply with Quality standards, including applicable SOPs and GxP* standards
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 Maintain strong focus on external and internal client satisfaction
 </li>
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 Represent Production Services at internal project meetings, Support the teams on a global basis in labeling and packaging, introduce our services and the business unit on the global level
 </li>
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 Coordinate study requirements from beginning to end
 </li>
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 Perform on the job training for the departmental team
 
 
 </li>
 </ul>
 
 Project Planning-Clinical Trial Supply Strategy
 
 
 
 <ul>
 <li>
 Provide support for set-up/development of project specific logistics strategy
 </li>
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 Provide input into development of documents, manuals and quality documentation including GMP relevant documentation
 </li>
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 Provide input into vendor selection
 </li>
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 Coordinate requirements with external groups including sponsor
 
 
 </li>
 </ul>
 
 Project Execution and Control
 
 
 
 <ul>
 <li>
 Develop manufacturing and packaging strategies with relevant stakeholders in line with GMP, GCP and other relevant regulations
 </li>
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 Propose supply strategies based on study progress, adjust accordingly and provide feedback to depots
 </li>
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 Propose package designs as required
 </li>
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 Contribute to the Production Specification through consultation with depot and Quality stakeholders
 </li>
 <li>
 Create Master Batch Records for packaging operations performed at PAREXEL depots
 </li>
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 Issue Production Specifications and pre-execution batch records, ensuring first time quality of batch and expiry date information
 </li>
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 Review and manage approval of production batch records from external Contract Manufacturing Organizations
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 Develop and purchase necessary packaging tools for use in PAREXEL depots
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 Review and manage approval of packaging tool specifications from external Contract Manufacturing Organizations
 </li>
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 Develop label artwork and secondary packaging materials
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 Purchase materials from external vendors
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 Perform QC on the print proofs or package solutions provided by vendors, approve the final approach for production
 </li>
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 Manage complaints following GxP guidelines
 </li>
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 Coordinate purchasing, manufacturing, distribution, return, recall and destruction of medication for clinical trials, as applicable
 </li>
 <li>
 Coordinate SPARC meetings
 </li>
 <li>
 Monitoring and management of pre-requisite materials required to enter production
 
 
 </li>
 </ul>
 
 Customer satisfaction and Client Liaison
 
 
 
 <ul>
 <li>
 Actively engage external and internal clients in solution improvements
 </li>
 <li>
 Act as point of contact for internal and external customers and use a consultative approach in issue resolution
 </li>
 <li>
 Proactively engage with external and internal clients in solution improvements
 </li>
 <li>
 Work towards establishing positive relationships with internal and external clients
 </li>
 <li>
 Represent Parexel at professional meetings/conferences as participant and/or speaker
 
 
 </li>
 </ul>
 
 Ensure Quality and Process improvement
 
 
 
 <ul>
 <li>
 Support ongoing optimization of system infrastructure
 </li>
 <li>
 Address and follow up on quality issues and CAPAs
 </li>
 <li>
 Contribute to development and writing of applicable SOPs, worksheets and procedures
 </li>
 <li>
 Prepare, participate in and follow up on audits/inspections
 </li>
 <li>
 Implement process improvements, in conjunction with the team, in response to corporate, quality, client and team feedback and quality audits
 </li>
 <li>
 Participate in meetings to identify process improvements &amp; innovation topics
 </li>
 <li>
 Capture identified metrics and present as appropriate
 
 
 </li>
 </ul>
 
 Skills
 
 
 
 <ul>
 <li>
 Result-oriented, confident, self-motivated
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 Proficient in Microsoft Office (MS Excel)
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 <li>
 Proficient in Adobe InDesign and Adobe Acrobat
 </li>
 <li>
 Good analytical capabilities combined with creative problem-solving skills and a sense of urgency
 </li>
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 Ability to prioritize workload
 </li>
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 Decision making
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 Positive, objective, balanced, and result-driven
 </li>
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 Organizational talent
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 Patience
 
 
 </li>
 </ul>
 
 Knowledge And Experience
 
 
 
 <ul>
 <li>
 Solid understanding of Good Manufacturing Practice regulations
 </li>
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 Experience in clinical logistics or related field within the biopharmaceutical industry
 </li>
 <li>
 Experience in Packaging, Labeling and Distribution of IMPs and Non-IMPs
 </li>
 <li>
 Practical understanding of the drug development regulatory and logistics framework
 </li>
 <li>
 Basic understanding of financial tasks
 </li>
 <li>
 Multinational work experience
 </li>
 <li>
 Fluent in English
 </li>
 <li>
 Minimum of 2 years&rsquo; experience in similar roles within the pharmaceutical industry &ndash; either with a sponsor or service organization
 
 
 </li>
 </ul>
 
 Education
 
 
 
 <ul>
 <li>
 Vocational or Bachelor degree, or equivalent in biology, pharmacy or other health-related discipline, international trade or logistics business
 </li>
 <li>
 Or relevant work experience / degree
 </li>
 </ul>
</div>

Production Services Coordinator

Join Parexel and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Parexel

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Supply and Logistics Leader

Production Services Coordinator