Senior Technical Writer, Imaging Services Systems

As Senior Technical Writer, Imaging Services Systems, you are responsible for driving imaging services systems and science technical initiatives cross-functionally within the organization to ensure the integrity of ongoing and future project clinical imaging requirements are met. This scope includes, but is not limited to; providing clinical imaging sciences support within Imaging Services, implementing, and validating new imaging applications, developing/implementing complex image review workflows, managing complex technical issue escalations, leading process improvements, and training team members where required. In this role, you will serve as a subject matter expert for defining the project level technical execution with sponsors, writing Trial Configuration Specification (TCS) documentation, blinded independent central review (BICR) criteria, image acquisition, image quality and image transfers.Key ResponsibilitiesTechnical Document Development and ReviewProvide technical contribution to imaging documents including Image Review Charter, Independent Review Training Manual, Study Reports, Technical Configuration Specifications and Technical Operation ManualsCoordinate and conduct reviews of technical documentation and document specifications on behalf of Medical WritingInitiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, central content, and general guidelines for clinical documentation and workflow proceduresLead initiatives for developing Imaging read/analysis system configurations at the project levelInitiate support for the Image Management group to develop more efficient processes to manage data movementDrive the Reader Management group at the project level to develop/implement reads in imaging systemsIdentify, evaluate and communicate potential risks related to deliverables as well as their mitigationStakeholder Relationship ManagementServe as the medical writing representative on assigned project teams communicate content requirements, lead/facilitate authoring team meetings to agree on expectationsServe as a primary client contact for technical configuration and specification document projects, negotiating deliverable timelines and resolving project related issues.Provide subject matter expert input in assessment of new and novel platforms and services for imaging viewing and processing and SME input on behalf of Imaging Services teamQuality managementDrive support for the Image Management group in preliminary QC efforts and movement of data using programmatic systems tools (e.g. PowerShell Scripts, etc.)Lead UAT development of Imaging read/analysis system configurations at the project levelSupport the Site Setup team in qualification and training of Imaging Centers including the creation of training materialSupport the Image Analysis and QC groups with escalated workflow QC and query activitiesOtherCarryout any other reasonable duties as requestedFunctional Competencies (Technical knowledge/Skills) Excellent interpersonal, verbal and written communication skillsDemonstrable knowledge of industry guidelines and regulations, i.e., ICH-GCPAbility to consistently produce documents of high quality with proven ability of using Microsoft Office products (including Word, Excel & PowerPoint)A flexible attitude with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailAbility to identify and implement process improvementsProactively participates in skills improvement training and encourages their teams to participateAbility to coach others to succeed; sharing knowledge, skills, and expertise to othersBuilds and maintains an in-depth knowledge of technology within the life sciences industry and how it affects customers adopting our productsExperience, Education, and CertificationSolid proven experience of working in and knowledge of medical imaging or clinical development in the life sciences industryExperience working effectively in a fast paced, matrix managed, multi-disciplinary environment with cross-functional teamsExperience troubleshooting medical image related issues, especially DICOMExperience with Multimodality Clinical Imaging Standard PracticesExperience with Imaging Read Criteria’s (e.g. RECIST 1.1, PCWG3, Lugano, etc.)Medical Writing experience, preferredExperience with MINT and MIM applications, desirableBachelor's Degree in a technical discipline (Medical degree/ PhD) or a related study, or equivalent project-related experienceMasters, desirableCertifications in 1 or more of the following: CNMT, RT(N)(CT)(MR), preferredEnglish: FluentThis role is remote. Candidates located in the following states: AZ, CT, DE, FL, GA, IL, MA, MO, NH, NJ, NC, PA, UT, VA are preferred. The annual base salary range for this role is $84,368- $120,000. This range represents the anticipated initial annual salary and will vary depending on several factors including the candidate’s experience and skills as well as market rate adjustment