Senior Associate SP&L Position Available In Somerset, New Jersey

Job Description:

Join a Legacy of Innovation 110 Years and Counting! DaiichiSankyo Group is dedicated to the creation and supply of innovativepharmaceutical therapies to improve standards of care and addressdiversified, unmet medical needs of people globally by leveragingour world-class science and technology. With more than 120 years ofscientific expertise and a presence in more than 20 countries,Daiichi Sankyo and its 16,000 employees around the world draw upona rich legacy of innovation and a robust pipeline of promising newmedicines to help people. In addition to a strong portfolio ofmedicines for cardiovascular diseases, under the Group’s 2025Vision to become a “Global Pharma Innovator with CompetitiveAdvantage in Oncology,” Daiichi Sankyo is primarily focused onproviding novel therapies in oncology, as well as other researchareas centered around rare diseases and immune disorders.

Summary:

This is an operational position, task oriented in the execution ofprocesses, as directed by senior staff, playing a supportive rolein ensuring adherence to Project objectives, budget control anddepartmental collaborations. Work is escalated if outside of scopeof role, and/or complexity. This position has strong knowledge ofGMPs and GCPs and is compliant with domestic and foreign regulatoryrequirement but may seek support on such items from time to time.

Has sufficient knowledge to identify critical issues or problemswith projects and/or identification of issues which may compromisepatient dosing or safety. Basic understanding of professionalworking environment as well as Quality Assurance and globalregulatory requirements such that identification of risks isrecognized and the need for CAPAs or reports on deviations isclearly understood. Basic knowledge of Import/export requirementsto the extent that there is overall recognition of globaldifferences exist and understanding of the need to address suchissues or concerns. Experience with IRT systems and support inmanaging the forecasting and planning of drug supply needs. Canparticipate effectively on a cross functional and on Global teams.

Responsibilities:

Works, under supervision, with outsourcing tosubmit appropriate requirements on a project basis. Supports teamin generating RFPs and in reviewing proposals and selectingvendors. This position also supports the management of the WOdevelopment and implementation. Supports packaging design andpatient kit supply preparation, label generations and approvals andassociated interactions with vendors. Supports regularvendor/sponsor discussions to identify risks and ongoing studysupport. Identifies critical issues which may compromise patientdosing or safety. Supports comparator sourcing requirements, RFPgeneration and working with outsourcing to submit appropriaterequirements on a Project basis. Vendor Management – supportinteractions with Vendors on packaging design and patient kitsupply preparation, label generations and approvals. Supportregular vendor/sponsor discussions to identify risks and ongoingstudy support. Ensures on time site shipments for subject andpatient dosing, and ensures that material is fully released priorto shipment to site Ensures compliance with all domestic andforeign regulatory requirements but may seek line managementsupport when necessary. Basic knowledge of Import/exportrequirements to the extent that there is overall recognition ofpotential global issues as regards import license requirements,shipment delays and is able to communicate the issues and supportresolution development. Support IRT design for control of drugdispensing and inventory management. Understand User specificationsin support of IRT processes and basic concepts of

IRTQualifications:

Successful candidates will be able to meet thequalifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)Bachelor’s Degree required Master’s Degree preferred ExperienceQualifications 4 or More Years related professional experiencerequired. Must have professional experience Project Management,Clinical Supply Management, and/or Clinical Trials CoordinationDemonstrated experience in working in any of these areas: inventorymanagement, forecasting, and distribution of drug supply needs,IXRS experience, managing vendors and contributing to budgetcontrol preferred Daiichi Sankyo, Inc. is an equalopportunity/affirmative action employer. Qualified applicants willreceive consideration for employment without regard to sex, genderidentity, sexual orientation, race, color, religion, nationalorigin, disability, protected veteran status, age, or any othercharacteristic protected by law.