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Alkermes has a robust Medical, Legal and Regulatory Review Committee which we refer to as the Copy Clearance Committee. This role will serve as the Medical Affairs Copy Clearance Committee (MA CCC) Coordinator and facilitate the submission and approval of Field Medical material (both proactive and reactive), supervise the approval process of Standard Response Letters and Booth Content for the Medi
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Review and update of Medicaid Rebate Processing system (MRB) in Model N Setup and maintenance of Medicaid Contracts terms and prices Lead and perform the processing of Medicaid claims Analyze rebate calculations for consistency and accuracy, research variances and resolve disputes Communicate with state Medicaid contacts regarding payments and disputes as needed Execute various reporting activitie
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The holder of this position is charged with leading validation effort to prove control of the critical aspects of Alkermes operations, related to process, cleaning, or other elements. Serve as a subject matter expert in process and cleaning validation. Support validation and requalification activities for process and cleaning including work in manufacturing area for collection of samples, cleani
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The Lead Validation Engineer provides technical leadership and accountability for computer system validation and ensures compliance with industry regulations, internal policies, and governing standard operating procedures. As the Validation Subject Matter Expert, this individual will lead cross functional teams in the application of computerized system validation practices. Position scope of respo
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The Process Engineer is responsible for ensuring the proper design, reliability approach and modification of process equipment such that it has the capability to consistently meet customer expectations. They will serve as the SME on process equipment and have an understanding associated with process use. Lead and participate in continuous improvement projects supporting the manufacture of sterile
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Alkermes is seeking an experienced contract IT Systems Analyst specializing in software support for the C ommercial and Medical Affairs organizations . The ideal candidate would have experience providing support for GxP, CFR 21 Part 11 compliant systems and associated change management and validation activities. In this role, the a nalyst will provide system support including activities such as us
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Alkermes is seeking an experienced IT Project Manager (Contract) to manage projects for the Commercial IT team. This role will lead and manage IT projects and work closely with internal stakeholders and external third party service providers to successfully implement new applications, enhancements, and services ESSENTIAL AREAS OF RESPONSIBILITY Successfully manage a variety of small to medium si
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Project support Responsible for coordination, logistics, tracking and administrative tasks in support of Clinical Development Operations and Global Clinical Services. Operational support Responsible for special projects supporting departmental operations. The preferred duration for this internship is 6 months. Duties and Responsibilities Supports and/or tracks access rights to Clinical Operations
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Roster & Alignment Update and maintain all roster and alignment deliverables, communications, and documentation for all commercial field teams. Manage Javelin software for accurate account alignment Partner with HR to coordinate field employee on/off boarding, & employee change management Lead and manage shared prescriber / account process with field management Manage roster information and ens
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Ph.D. in Analytical Chemistry/Chemistry with 15+ years relevant experience in analytical development roles in the pharmaceutical industry Expertise in small and large molecule analytical method development and validation Extensive knowledge of advanced analytical principles and theories; expertise in analytical laboratory techniques for drug substance and drug product and application of control s
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Oversee chemical handling procedures and practices. Conduct assessments and classification of new chemicals. Perform risk assessments to evaluate the proper handling of biological materials. Monitor compliance with laboratory safety programs, particularly as they relate to chemical hygiene and biosafety. Conduct ergonomic assessments to support both office and remote based employee workstations. D
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s and programs of work E nsure compliance across all EHS regulatory and permit/ licensed requirements Partner with key functional stakeholders to instill collective accountability and embed a self sustaining culture of EHS excellence Actively sponsor the implementation and evolution of the company's behavioral risk program (CaRE) to achieve the highest levels of employee engagement and ownership r
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Alkermes has an exciting new opportunity for a talented scientist to join our Research Organization as Director/Senior Director, In Vitro Pharmacology, to lead an in vitro research team to prosecute early stage targets for advancement into our pipeline within our core scientific areas of the company. The successful candidate will be well experienced in drug discovery fundamentals and have a track
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Director, Regulatory Affairs CMC Biologics Alkermes Overview Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patie
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Provides strategic leadership of our Incentive Compensation (IC) and President's Club (PC) programs, including IC Design and President's club design, in close partnership with the leadership of our field teams, HR and Finance Make recommendations around our designs and goal setting methodologies based on strong analytics including the modeling, testing, and validation of the work Lead the execut
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