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Clinical Supplies Manager

Company: Catalent Pharma Solutions, Inc.
Location: Morrisville
Posted on: November 19, 2021

Job Description:

Job Description Position Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here Clinical Supplies Manager The Clinical Supplies Manager will be performing the activities required to provide leadership and support in the planning, development, and execution of clinical supply chain activities and the ability to drive cross-functional deliverables and manage activities of supply partners and functions (e.g. packaging and distribution, depots, logistics). The Clinical Supplies Manager is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials. The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise. The Clinical Supplies Manager's role is critical to our patients. Management of clinical drug supply in order to maintain a successful trial with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role! The Role * Understand and translate clinical study protocol requirements into demand for drug product within a clinical study * Create initial study drug projections and supply plan for clinical supply needs throughout life of study including multiple drug campaigns and appropriate drug strategies * Assist in re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrollment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans * Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug * Provide input to IRT specification design. Recommend IRT threshold levels and optimizes as required to make efficient use of clinical supplies while avoiding stock outs at study sites * Coordinate with client and packager to forecast, plan and scheduling of packaging campaigns and drive timeline to desired deliverable * Other duties as assigned The Candidate * Bachelor's degree in a science, supply chain or related discipline * 6+ years of relevant industry experience with at least 4 years in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle preferred * Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management * Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR), * Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical supply * Strong knowledge in IRT technology as it relates to supply chain management * Skilled in client relationship management and ability to influence customer demand Why You Should Join Catalent * Lots of Growth/Development opportunities * 19 Days of PTO (Paid Time Off) per year * Tuition Reimbursement Program * Cross-functional exposure across Catalent * Employee Stock Purchase Plan Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit www.catalent.com/careers to explore career opportunities. Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

Keywords: Catalent Pharma Solutions, Inc., Cary , Clinical Supplies Manager, Executive , Morrisville, North Carolina

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