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The Sr. Director, Regulatory Affairs is responsible for leading the activities of global Regulatory Affairs. This role will lead the strategy, preparation, review and submission of documents to the FDA and other national authorities to support new product development and regulatory aspects through the product lifecycle for multiple business units. This role must be able to combine knowledge of scientific, regulatory and business issues to assure that products are developed, manufactured, and distributed according to all national, regional, and local laws and regulations pertinent to the manufacturing and distribution of medical devices and/or IVDs. The Sr. Director, Regulatory Affairs will recruit, develop, mentor, and lead regulatory professionals.
Exact Sciences is seeking an exceptional individual with strong statistical programming and analytical skills to participate in the development, validation, and post-marketing support of genomic biomarker assays that help cancer patients and their physicians make better treatment decisions. As a member of the Clinical Biostatistics team, the Senior Statistical Programmer will perform statistical analysis on data from diverse sources, using Base SAS, SAS Macros, SAS/STAT SAS/Graph, SAS/SQL, and SAS/ODS to create and maintain tables, listings, and graphs. This position will create analysis datasets in a standard format following specifications or per study needs, assesses quality of data analysis programs, where appropriate. In addition, this role will collaborate closely with Clinical Biostatistics, Data Management Operations, Clinical Development, Clinical Operations, Medical Communications, and Medical Affairs to provide expertise in the generation of statistical analyses/reports.
The Associate Data Scientist performs data analysis to extract knowledge or insight from structured or unstructured data. He or she applies advanced statistical algorithms for analysis of large-scale, complex datasets. He or she keeps up to date with cutting-edge techniques in programming, machine learning, big data, and healthcare modeling and seeks ways to advance the organization’s capabilities in analytics.
Exact Sciences is seeking a talented Senior Software Engineer I with a strong background in customer facing web application design and development. This role will be responsible for designing, developing, and supporting Sitecore based web application solutions in a fast-paced, high growth bio-tech company.
The Staff Accountant position is responsible for maintaining general ledger accounts and business transactions of the organization, applying Generally Accepted Accounting Principles (GAAP). This includes creating financial transactions and creating financial reports from that information. This includes evaluating transactions for proper classification and making decisions regarding the posting of the transactions. The Staff Accountant also reconciles accounts to ensure their accuracy. In addition, the Staff Accountant assists with establishing policies and procedures for financial reporting and helps maintain the Company’s Sarbanes-Oxley (SOX) 404 compliance.
The Sales Excellence Specialist provides sales operations support for Exact Sciences Screening business unit team members to develop, execute, and manage strategy and processes for successful commercialization of business unit initiatives.
The Patient Advocacy and Alliance Relations Director will lead the company’s relationships and interactions with leading advocacy groups. This position is responsible for directing the U.S. based Precision Oncology and Pipeline Patient Advocacy program. The Advocacy program currently spans more than 60 leading patient advocacy organizations in bladder, breast, colon, liver, and prostate cancer. The expectation is that as the pipeline matures, additional disease specific communities will be added to the Patient Advocacy portfolio. Partnerships and programs focus on education around personalized medicine, precision oncology, and the value of early detection; policy collaborations; integration into appropriate research streams; and integrating the patient perspective across all aspects of the company. The Patient Advocacy and Alliance Relations Director is also responsible for overseeing and managing the Patient Ambassador program, highlighting the experience of patients who use Exact Sciences products.
The Patient Advocacy and Alliance Relations Director will develop and implement strategic, results-oriented programs to reach relevant patient advocacy audiences. This person will work collaboratively with all members of the Medical Organization, Communications department, and numerous internal stakeholders, including Marketing, Sales, IT, Pipeline, Research & Development, and Legal departments.
A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of Cologuard and Oncotype DX, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer.
The Company is looking for an experienced patent agent to draft and prosecute biotech patent applications worldwide, develop global patent strategies, and manage day-to-day IP activities to support multiple oncology products. This role requires the development of strong partnerships with R&D, as well as within the Legal department.
The Compliance Counsel will have various responsibilities for effectively and efficiently executing a compliance program that meets or exceeds legal and regulatory expectations. This position will work with leadership throughout Company, with a primary focus on Exact Sciences’ Precision Oncology, for the purpose of continually enhancing the Company’s efforts to ensure compliance with health care industry laws and standards through the development and delivery of real-time guidance and counsel, policies/procedures, internal messaging and training content, and written agreements and external-facing materials that enable achievement of the Company’s mission and financial goals without compromise of its Core Values. The Compliance Counsel will be responsible for directing the following transactional compliance efforts of Exact Sciences: advising leadership and project teams on the implications of legal risks and industry best practices for commercial strategies, tactics and programs; leading the development of procedures and substantive responses for real-time inquiries from personnel within the commercial organization; providing health and privacy law expertise on engagements involving health care providers/institutions and/or patient information and other data exchange and usage issues; and enhancing the organization’s efforts to create and deliver effective training, education and internal communications supporting the Company’s efforts to identify and address matters of concern.
This opportunity will report to the Vice President and Chief Compliance Counsel of Exact Sciences Corp.
The Associate Lead, Laboratory Processing (known internally as Laboratory Processing Workflow Coordinator) performs the functions of Specimen Processing under the guided direction of the Specimen Processing Supervisor, Lead or designee. The Specimen Processing Workflow Coordinator follows laboratory policies and procedures and maintains accurate data reporting practices to ensure consistent and diligent execution of specimen processing. In this support position the Specimen Processing Workflow Coordinator ensures daily lab operations are effective and efficient by providing direction and guidance to employees during their assigned duty station.
The hours for this position are Tuesday - Friday from 8:00pm - 6:30am.
The IT Project Manager plans, directs, and coordinates activities of corporate projects to ensure that goals or objectives of projects are accomplished within prescribed time frame and funding parameters. Ensures that project goals are accomplished and in line with business objectives.
The Senior IT Project Manager plans, directs, and coordinates activities of corporate projects within the Exact Sciences IT ecosystem to ensure that goals or objectives of projects are accomplished within prescribed time frame and funding parameters. This position ensures that project goals are accomplished and in line with business objectives.
Working on our Oncology Sales team, the Regional Oncogenomic Liaison (ROL) will develop and implement a plan to maximize the utilization of our products in targeted accounts, while staying within budget, and support the corporate objectives and highlight the delivery of our key selling messages. The ROL should incorporate a high level of service toward being the best in class for an assay provider. The ROL’s plans are used to solve challenging problems in a dynamic environment. The plans should emphasize the need to build and maintain comprehensive relationships and develop key contact and account records in Exact Sciences’ CRM system to manage these relationships. To do this plan, the ROL must have, or be able to quickly develop, a clear understanding of key territory-related clinical/political issues. The ROL will devote whatever time is necessary to complete objectives outlined in the sales plan.
The ROL provides information critical to accomplishing the Exact Sciences mission to all parties involved in the sales of our products. The ROL will provide direct feedback to individuals so they can make accurate decisions at all levels of the company (national, regional and area teams). The ROL will work with managed care, reimbursement, patients (including patient support groups), Exact Sciences Advocacy group and providers to ensure access to our products.
This position is field based.
The Systems Test Engineer II works with the Systems Development team to ensure that custom in vitro diagnostic systems meet design and customer requirements. The Systems Test Engineer II uses a technical background in software development and engineering, combined with an understanding of the system design, to analyze user needs, requirements and specifications to create testing strategies and plans for verification and validation of the system designs.
The Workforce Specialist is responsible for administrative workforce duties. This position will assist in creating and maintaining workforce management policies and procedures and will partner with Customer Care Center leadership to determine the most effective method of communicating changes to all associates. This position ensures that the Customer Care Center teams have the right number of skilled associates in the right place at the right time to handle an accurately forecasted workload at the desired service level and response time goals. This position communicates real time and historical workforce performance results to the Customer Care Center teams. This position will partner with Workforce Management leadership to provide information to Customer Care Center Leadership on associates about appropriate work statuses and behavior documented in order to achieve our goals. This position will require real time monitoring of call queues, responses to email inquiries received from patients and maintaining a call volume balance with calls arriving in the center, as well as the automated outbound calling application. If workload warrants, this position may support other functions of the Customer Care Center.
The Director, Corporate Strategy is a highly visible, influential, and interactive position that serves as an expert resource and consultant to executive management in the assessment of a variety of strategic initiatives. This position helps define and shape corporate strategy, track industry trends, evaluate market opportunities, and support leadership in aligning resources to execute and deliver on those strategies. This position reports into the corporate strategy function but collaborates closely with the Business Development and AOPH (Access Outcomes & Population Health) team and must also work closely with Screening, Precision Oncology, International, and Pipeline business leadership. This role provides strategic leadership to cross-functional teams by working to define clear and realistic goals, clearing barriers to success, developing a clear management view of assigned projects and how they fit into the strategic landscape, and understanding of all the skills and tasks associated with successful project execution. This person is also responsible for supporting a collaborative environment that promotes positive teamwork where all members are working for the good of Exact Sciences. The successful candidate will demonstrate outstanding strategic thinking, collaboration, and communication.
The Sales Excellence Business Liaison provides strategic business, operational, and analytical services to the commercial organization by acting as a connection between Sales, Commercial Operations, Data Services, and other IT teams to facilitate collection and documentation of business requirements. This position is responsible for then translating those requirements into technical documentation and conceptual design (using appropriate tools and models) from which applications and solutions are developed. The focus of this position is to work closely with the sales and commercial operations stakeholders to gain in-depth understanding of business strategy, processes, services, roadmap and the context in which the business operates.
This Sales Excellence Business Liaison supports the Precision Oncology business unit.
The Supervisor, Clinical Laboratory Quality Control works with the Clinical Laboratory Manager to coordinate, develop and communicate the Quality Control and Quality Assurance programs of the clinical laboratory. This position works collaboratively with the Quality Assurance team to coordinate and ensure the proper execution of proficiency testing, non-conforming event tracking, including escalation, root cause analysis, risk assessments. This position collaborates with the technology transfer group to ensure all aspects of new tests and enhancements are appropriately executed. Additionally, they will work with all managers and supervisors to ensure workflow enhancements including IT, automation and employee suggestions are evaluated and adopted as appropriate. The position, as necessary, performs complex laboratory tests in the clinical laboratory to provide physicians with rapid and accurate laboratory test results.
The Strategic Initiatives Specialist will be responsible for managing, organizing, and tracking strategic and growth initiatives across the Commercial team within the Screening Business Unit. The position will coordinate with multiple functions across the organization, both commercial and lab, to plan and execute these commercial initiatives.
The Senior Manager, Sales Operations provides sales operations leadership for the Exact Sciences sales force. This role is focused on Customer Relationship Management (CRM) and Sales Force Automation and Administration (SFAA) aspects of the sales support infrastructure.