The medical writer has responsibility for an assigned subset of medical writing projects associated with the Clinical Science function, primarily focused on clinical studies needed to acquire clinical evidence in support of regulatory submissions to healthcare authorities. The medical writer works with little or no assistance to collaborate across functions for purposes of drafting, editing, and finalizing clinical study protocols, clinical study reports, and amendments to those documents. He/she provides input for case reports forms, statistical analysis plans, and data analysis tables to ensure registrational clinical studies provide high-quality information. He/she provides medical writing representation for project teams and as needed, for the strategic clinical trial core team. He/she may be asked to participate in joint project team meetings with pharmaceutical partners.
* Designs scientifically sound studies in conjunction with clinical science lead, clinical operations study manager, and biometrics representative to support new product development in molecular probes, immunohistochemical reagents and new instrument platforms;
* Actively participates on project teams/extended project teams for purposes of planning clinical validation activities for 510(k) and PMA level in vitro diagnostic assay registration programs with focus on preparing clinical study protocols that validate the intended use for Class II/III products in development;
* Coordinates beginning-to-end clinical study protocol development activities which includes gathering cross-functional input, hosting meetings to formulate the investigational plan, preparing synopses for use in FDA pre-submissions and request for proposals (RFPs), developing the study concept into full clinical study protocols, incorporating review comments and finalizing the complete clinical study protocol;
* May contribute content for pre-submission documents;
* Interfaces with Regulatory Affairs, Medical Office, Research & Development, Quality and other functional groups internally to coordinate cross-functional contributions to regulatory submissions;
* Reviews clinical trial protocols from pharmaceutical partners to evaluate the relationship with or impact on the investigational plan for a companion diagnostic and may participate in joint team meetings, as needed;
* Collaborates with Clinical Operations and Data Management representatives to ensure seamless transition from protocol development to study execution;
* Critically reviews case report forms that accompany study protocols to ensure appropriate data collection during clinical study execution;
* Interacts with biostatisticians to ensure alignment between the objectives stated in the investigational plan and the planned statistical analyses;
* Critically reviews results from clinical studies, including review of draft tables, listing and figures provided by biostatisticians. Interprets results to include in the clinical study reports;
* Prepares properly formatted clinical study reports that summarize the clinical study activities and provide the clinical performance data required to support Class II/III product registrations and marketing applications;
* Exercises professional judgement with regard to report content;
* Tracks progress of assigned medical writing deliverables to ensure timelines and other project team needs are met;
* Serves as a functional area subject matter expert for document management; and
* Provides status updates for their assigned medical writing deliverables.
Are equivalencies acceptable? Yes. Graduate level coursework of professional certifications may be replaced with experience if candidate has exceptional qualifications and recommendations. Exceptions for required education and experience may be considered for an extremely qualified candidate with demonstrated ability to meet the job requirements.
Knowledge, Skills, and Abilities:
* Application of scientific principles and concepts;
* Industry standards and guidance as it relates to IVD product development and design control;
* US 510k and PMA regulatory environment and relevant guidance from FDA, CLSI, CAP/CLIA; Including familiarity with 21 CFR Parts 11, 50, 54, 56, 801, 809, 812, 814, 820, and 860;
* ICH E6 good clinical practice and ICH E3 structure and content of clinical study reports;
* European regulation on in vitro diagnostic medical devices. Regulation (EU) 2017/746;
* Diagnostic testing laboratory workflow, histology, immunohistochemistry, and molecular biology;
* Product and related disease area medical and scientific knowledge; and
* Knowledgeable of current trends in oncology, cancer screening and diagnostics, and anatomic pathology.
* Computer literacy including keyboarding skills and proficiency with software programs used to prepare study-related documents (Ability to use Adobe Acrobat Professional, Microsoft WORD, Microsoft PowerPoint is required. Experience with EndNote and Microsoft Visio is preferred);
* Excellent verbal, written and presentation communication skills;
* Skilled at reviewing and editing the work of others;
* Strong understanding of clinical study design and interpretation of study results; and
* Outstanding organizational skills.
* Exercise good judgement with regard to when issues require consultation with additional thought leaders;
* Demonstrate creativity and ingenuity through the development of novel, multi-disciplinary approaches to projects and strategic issues;
* Apply critical thinking and problem solving skills and use logic and reasoning to support recommendations to the project team;
* Understand statistical basis for sensitivity, specificity, and reproducibility testing required for validation of diagnostic tests;
* Work collaboratively across all levels of the organization;
* Produce protocols and reports independently;
* Evaluate and edit the writing of others;
* Drive progress on multiple projects simultaneously;
* Follow processes and operate within fast-past environment with high regard for urgent timelines;
* Prioritize work and meet timelines;
* Develop expertise in the company's internal document management system;
* Interface with internal and external partners to achieve results; and
* Demonstrate passion for improving the lives of all patients afflicted with cancer.