Senior Technical Writer, Imaging Services

Calyx

$84K — $120K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5-7 years of proven medical imaging or clinical development experience in the life sciences industry.
  • Strong troubleshooting skills for medical image-related issues, especially DICOM.
  • Experience with Multimodality Clinical Imaging Standard Practices and Imaging Read Criteria.
  • Bachelor's Degree in a technical field; Master's degree preferred.
  • Certifications in imaging modalities like CNMT or RT(N)(CT)(MR) are desirable.
  • Ability to thrive in fast-paced, cross-functional team environments.
  • Fluent in English with exceptional verbal and written communication skills.

Responsibilities

  • Lead the development and review of key technical documentation for imaging services.
  • Coordinate interdepartmental reviews of technical documents to ensure compliance and accuracy.
  • Drive process improvement initiatives within Imaging Services and train team members accordingly.
  • Manage stakeholder relationships and act as the primary client contact for project deliverables.
  • Oversee quality control efforts and support for data management in imaging systems.
  • Assist in User Acceptance Testing (UAT) development for imaging analysis configurations.
  • Conduct any additional duties as assigned related to imaging services.

Benefits

  • Flexible remote work options available in select states.
  • Opportunities for professional development and training.
  • Access to industry-leading tools and technologies.
  • Collaboration with cross-functional teams in a dynamic environment.
  • Potential for career advancement within the organization.
Full Job Description
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 Responsibilities Technical Document Development and Review 3 Provide technical contribution to imaging documents including Image Review Charter, Independent Review Training Manual, Study Reports, Technical Configuration Specifications and Technical Operation Manuals. 3 Coordinate and conduct reviews of technical documentation and document specifications on behalf of Medical Writing. 3 Initiate 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 procedures. 3 Lead initiatives for developing Imaging read/analysis system configurations at the project level. 3 Initiate support for the Image Management group to develop more efficient processes to manage data movement. 3 Drive the Reader Management group at the project level to develop/implement reads in imaging systems. 3 Identify, evaluate and communicate potential risks related to deliverables as well as their mitigation. Stakeholder Relationship Management 3 Serve as the medical writing representative on assigned project teams communicate content requirements, lead/facilitate authoring team meetings to agree on expectations. 3 Serve as a primary client contact for technical configuration and specification document projects, negotiating deliverable timelines and resolving project related issues. 3 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 team. Quality management 3 Drive support for the Image Management group in preliminary QC efforts and movement of data using programmatic systems tools (e.g. PowerShell Scripts, etc.). 3 Lead UAT development of Imaging read/analysis system configurations at the project level. 3 Support the Site Setup team in qualification and training of Imaging Centers including the creation of training material. 3 Support the Image Analysis and QC groups with escalated workflow QC and query activities. Other 3 Carryout any other reasonable duties as requested. Functional Competencies (Technical knowledge/Skills) 3 Excellent interpersonal, verbal and written communication skills. 3 Demonstrable knowledge of industry guidelines and regulations, i.e., ICH-GCP. 3 Ability to consistently produce documents of high quality with proven ability of using Microsoft Office products (including Word, Excel & PowerPoint). 3 A flexible attitude with respect to work assignments and new learning. 3 Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. 3 Ability to identify and implement process improvements. 3 Proactively participates in skills improvement training and encourages their teams to participate. 3 Ability to coach others to succeed; sharing knowledge, skills, and expertise to others. 3 Builds and maintains an in-depth knowledge of technology within the life sciences industry and how it affects customers adopting our products. Experience, Education, and Certifications 3 Solid proven experience of working in and knowledge of medical imaging or clinical development in the life sciences industry. 3 Experience working effectively in a fast paced, matrix managed, multi-disciplinary environment with cross-functional teams. 3 Experience troubleshooting medical image related issues, especially DICOM. 3 Experience with Multimodality Clinical Imaging Standard Practices. 3 Experience with Imaging Read Criteria's (e.g. RECIST 1.1, PCWG3, Lugano, etc.). 3 Medical Writing experience, preferred. 3 Experience with MINT and MIM applications, desirable. 3 Bachelor's Degree in a technical discipline (Medical degree/ PhD) or a related study, or equivalent project-related experience. 3 Masters, desirable. 3 Certifications in 1 or more of the following: CNMT, RT(N)(CT)(MR), preferred. 3 English: Fluent. This 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.

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