13 access reimbursement manager jobs found in Durham

Biogen This position will be hybrid (3 days per week on site) and can either sit at our Cambridge MA location OR our Research Triangle Park, NC location About This Role The Sr Manager, Supply Chain Quality Lead is responsible for providing oversight and support to all distribution quality related activities within the USA. They are responsible for developing quality awareness and inclusion in all processes and facilitate or mentor processes required for the establishment of effective quality management systems. The Sr Manager will liaise with all functions within our Pharma Operations & Technology division and outside to assure seamless processes and patient access to medicines. This person will have QA oversight of logistics of products' distribution worldwide and management of deviations, CAPAs, Change Controls, audits and serialization. What You'll Do Ensure quality and uninterrupted supply through the application of quality measures throughout the supply...

Biogen This position is a M-F business hours schedule (8A-5P) and is full time on-site at our RTP facility About This Role As an Associate III, QC Raw Materials, you will play an integral role in the Quality Control Raw Materials team at the Biogen RTP Pharma site. This critical position supports functional, tactical, and operational objectives by sampling, inspecting, and testing raw materials while maintaining strict adherence to cGMP documentation standards. Your expertise in Gas Chromatography (GC) and wet chemistry will be essential as you perform compendial testing and manage data entry into electronic laboratory information management and inventory systems. Collaborating closely with QC teams, Quality, Planning, Warehouse, Validation, and Manufacturing teams, you will help ensure that operations run smoothly. Your role may also involve assisting with GMP compliance activities, investigation writing, and continuous improvement initiatives. By working independently and...

Biogen Job Title: Development Asset Lead, Director Development About This Role: As a Development Asset Lead (DAL), you will play a pivotal role in leading the strategic development and execution of one or more preclinical or clinical stage portfolio assets within our Development team. This full-time leadership position requires you to craft and implement an integrated asset plan (IAP) that maximizes value creation and delivery. You will ensure that all functional voices are represented and that business considerations of time, risk, and value are integrated seamlessly into the planning and execution phases. This role is crucial to our business, as you will be accountable to governance mechanisms for asset-related decisions and represent the asset at portfolio governance forums. Through strategic partnership with the Program Manager, you will ensure the efficient and timely execution of the asset plan, fostering a strong team culture and maintaining alignment with our...

Biogen About This Role: As the Director of Quality Control, you will provide both strategic and operational leadership for the Pharma Site Quality Control (QC) Operations organization. In this pivotal role, you will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (microbiology) of various stages of drug substance and drug product material manufactured in our Parenteral Filling, Antisense Oligonucleotide, and Oral Solid Dose (OSD) operations at RTP Pharma. You will develop and manage QC budget plans and lead the management of laboratory quality systems, including analytical instruments & equipment, testing procedures. Your contributions to overall site strategy, global milestone projects, and ensuring adherence to all regulatory requirements will all be in support of our clinical and commercial supply chain. What You'll Do: Lead the Pharma Site QC Operations organization - Management of...

Biogen About This Role: As the Global Training Compliance - Corporate Quality, you will be at the forefront of ensuring the quality and compliance oversight and execution of our global GxP Training process as member of the Corporate Quality team. This pivotal role involves acting as Quality Unit for the Global GxP Training process and the Business System Owner for the Veeva Vault Training system, ensuring its alignment with both regulatory standards and organizational objectives. You will spearhead the design, implementation, and ongoing improvement of this system, collaborating with cross-functional teams to maintain high compliance standards. By monitoring metrics and KPIs, and escalating issues to senior leadership, when necessary, you ensure that our training process is not only efficient but also enhances our global operations. Your insights will be invaluable during audits and inspections, as you represent the process to regulatory bodies. Embedded within a global...

Biogen About This Role As a Senior Associate I, Quality Control (QC), you will play a critical role in ensuring the integrity, accuracy, and compliance of analytical testing that supports drug substance and drug product release. What You'll Do Perform and review analytical testing for product release, stability studies, and method validation. Lead method transfer and qualification activities. Author protocols, technical reports, and change controls. Mentor peers and contribute to cross-functional process improvement initiatives. Conduct impact assessments related to compliance (e.g., global directives, audit readiness, deviations). Review and approve complex reports and data generated by others; lead complex problem-solving through facilitation and escalation when needed. Evaluate the impact of QC activities on project teams, including implications for batch release and stability data. Support setting and reporting of measurable goals, targets,...

Biogen About this Role In this Parenteral Filling Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset. What You'll Do Author manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot records management and project execution -participate in projects (simple to moderately complex in nature), facilitating timely execution. Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production...

Biogen Job Title: Sr. Technician II, Instrumentation & Controls Schedule is Mon-Friday, 7a-330p About This Role: As a Sr. Technician II in Instrumentation & Controls, you will play a crucial role within the PO&T team by performing both corrective and preventative calibrations on a variety of manufacturing, facility, and laboratory analytical instruments. Your expertise will support manufacturing and laboratory personnel in maintaining the functionality and accuracy of critical equipment, ensuring seamless operations. You will often collaborate with engineering and validation teams to address equipment failures and support validation activities. By authoring changes to procedures and job plans, you will help refine our processes and maintain our high standards. This role is vital in minimizing downtime, enhancing productivity, and ensuring compliance with industry regulations, thereby supporting the overall business objectives. What You'll Do: Perform...

Biogen About This Role The Sr Associate I will support and lead team initiatives regarding compliance, documentation, writing deviations, lab exceptions, Actions, and environmental excursions. The Sr Associate I must have practical knowledge of current regulations and cGMPs to ensure all work is performed in a cGMP manner, with adherence to regulatory regulations. What You'll Do Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions Author technically sound moderately complex reports with minimal guidance Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels for completion of deliverables Initiate and monitor QC laboratory documentation, such as Standard Operating Procedures and periodic review of laboratory procedures and see them through to completion May provide Quality Unit...

Biogen About This Role: As a Senior Category Manager for Direct Materials, you will play a pivotal role in optimizing and innovating key categories crucial to Biogen's operational footprint. Reporting to the Associate Director of Global Strategic Sourcing, this position sits on the Global Strategic Sourcing team, focusing on the direct material space for internal manufacturing operations, including categories like chemicals, filters, and resins. You will be responsible for managing category strategies and sourcing initiatives across various modalities, such as Biologics, Oral Solid Dosage, Parenteral filling, ASOs, and Clinical Label & Packaging. This Senior Manager will ensure the needs of the business are met by leading category management, sourcing strategies, and sourcing process from defining business needs, knowledge of supply marketplace, executing RFx events, lead contract negotiations, supply risk management, and supplier relationship management. What You'll...

Biogen About This Role The Associate Director of Strategic Project Management for Patient Services will serve as a leader driving the vision, strategy, and execution of complex digital initiatives that transform patient engagement for consumers, support, and operational workflows. Leveraging your years of progressive project management experience, you will oversee the end-to-end delivery of high-impact programs, ensuring alignment with organizational goals, regulatory requirements, and industry best practices. You will lead and mentor cross-functional teams, champion innovation, and foster collaboration across business, IT, and external partners. Your expertise will be pivotal in implementing scalable digital solutions that enhance patient experience, streamline service operations, and deliver measurable improvements in outcomes and satisfaction. What You'll Do Strategic Leadership & Digital Transformation for Consumers Lead the design, planning, and execution...

Biogen About This Role The position of Sourcing Analyst resides within the Direct Materials sourcing team and provides support to the Category Managers related to savings, reporting, metrics, contracting and supplier relationship management. This role supports supplier oversight activities under the guidance of senior team members. This role will report into the Associate Director, Global Strategic Sourcing, Direct Materials and sits within Global Business Services. What You'll Do Performs analysis and reporting of savings tracking and category performance management. Assists in developing procedures and tools to support the process and makes system updates as needed. Supports Category Management strategy planning by providing data analysis and preparing templates and reports. Establishes templates and reporting capabilities for Direct Materials Category Management in collaboration with team members. Assists in sourcing, negotiating, and contracting strategies...

Biogen About This Role At Biogen, we are driven by our mission to pioneer science for the benefit of humanity - and that includes creating a workplace that protects the health, safety, and well-being of every employee, contractor, and visitor. As the EHS Manager, you will lead the development, implementation, and continuous improvement of Biogen's Environmental, Health, and Safety (EHS) Management System. This role is a key member of the PO&T/EHS organization and is responsible for managing site-specific EHS programs, ensuring regulatory compliance, and promoting a strong culture of safety and sustainability. You will oversee EHS operations, training, communications, and management system processes while partnering closely with business leaders, global colleagues, and functional teams to support Biogen's values of safety, integrity, and accountability. What You'll Do Lead and Manage EHS Programs: Direct site-level implementation of Biogen's EHS Management...