[Hiring] Senior Technical Writer, Imaging Services @Calyx

Role 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
• 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

• Provide technical contribution to imaging documents including Image Review Charter, Independent Review Training Manual, Study Reports, Technical Configuration Specifications and Technical Operation Manuals.
• Coordinate and conduct reviews of technical documentation and document specifications on behalf of Medical Writing.
• 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.
• Lead initiatives for developing Imaging read/analysis system configurations at the project level.
• Initiate support for the Image Management group to develop more efficient processes to manage data movement.
• Drive the Reader Management group at the project level to develop/implement reads in imaging systems.
• Identify, evaluate and communicate potential risks related to deliverables as well as their mitigation.

Stakeholder Relationship Management

• Serve as the medical writing representative on assigned project teams, communicate content requirements, lead/facilitate authoring team meetings to agree on expectations.
• Serve 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 team.

Quality Management

• Drive 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 level.
• Support the Site Setup team in qualification and training of Imaging Centers including the creation of training material.
• Support the Image Analysis and QC groups with escalated workflow QC and query activities.

Other

• Carry out any other reasonable duties as requested.

Functional Competencies (Technical knowledge/Skills)

• Excellent interpersonal, verbal and written communication skills.
• Demonstrable knowledge of industry guidelines and regulations, i.e., ICH-GCP.
• Ability 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 learning.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
• Ability to identify and implement process improvements.
• Proactively participates in skills improvement training and encourages their teams to participate.
• Ability to coach others to succeed; sharing knowledge, skills, and expertise to others.
• 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

• Solid proven experience of working in and knowledge of medical imaging or clinical development in the life sciences industry.
• Experience working effectively in a fast paced, matrix managed, multi-disciplinary environment with cross-functional teams.
• Experience troubleshooting medical image related issues, especially DICOM.
• Experience with Multimodality Clinical Imaging Standard Practices.
• Experience with Imaging Read Criteria’s (e.g. RECIST 1.1, PCWG3, Lugano, etc.).
• Medical Writing experience, preferred.
• Experience with MINT and MIM applications, desirable.
• Bachelor's Degree in a technical discipline (Medical degree/ PhD) or a related study, or equivalent project-related experience.
• Masters, desirable.
• Certifications in 1 or more of the following: CNMT, RT(N)(CT)(MR), preferred.
• English: Fluent.

Benefits

• Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs)
• Paid time off policy including holidays and sick time
• Internal growth and development programs & trainings
• 401(k) program, life & accident insurance and disability insurance

Company Description

Our mission is to shape the future of clinical research. With decades of experience and the brightest minds in the industry, we help the global biopharmaceutical industry bring new, advanced medical treatments to market, faster. We seek to change the world, and with the support of our teams across the globe, we flourish together. At Perceptive, we are one team. We learn, grow and win together.