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Senior Medical Writer

Laboratory Corporation of America Holdings (Covance)

Durham, North Carolina, United States

Job Overview:

Senior Medical Writer

Home-Based in the United States

Full-Time Write, edit, and coordinate completion of clinical study protocols, clinical study reports (annual, interim, and final), responses to queries and deficiencies, literature reviews, clinical evaluation reports (CERs), Summaries of Safety and Performance (SSCP), Summaries of Safety and Effectiveness Data (SSED) and other clinical documents in accordance with applicable regulations and guidelines for submission to regulatory authorities. Write, edit and coordinate completion of abstracts, posters, presentations, manuscripts and other documents for dissemination of clinical data. Serve as the project manager for the writing, editing, quality control and finalization of clinical reports and protocols, including primary responsibility for the direction, scope, content and organization of specific documents in consultation with the Project Advisor, Statistician, client, Regulatory, and project team as appropriate. Lead the Medical Writing team on large-scale writing projects, as appropriate, with support from management. Influence teams to adhere to the relevant medical writing requirements for projects. Act as Medical Writing lead and liaison to internal and external clients. Represent Covance at scientific and medical writing forums. Lead Medical Writing initiatives to develop and improve processes, including new technologies. Influence other department staff to accept and embrace new working practices. Represent the Medical Writing department at inspections, audits, and inter-department working group meetings. Perform literature searches/reviews to obtain background information for development of documents including protocols, clinical reports, meta-analyses, publications and other documents as required. Assist with study designs involving traditional epidemiological frameworks (e.g., case-control, prospective and retrospective cohort, etc.) as requested. Demonstrate initiative and manage Medical Writing situations independently.  Present solutions and influence Management and teams to adopt recommended strategies. Research and assess the appropriateness of various health outcome measures. Support development of study designs and case report forms (CRFs) that utilize such measures. Review Statistical Analysis Plans to determine organization, table layout, and content for clinical reports. Provide input into CRFs in collaboration with the cross-functional study team. Mentor, provide guidance and train Medical Writing. Review and understand regulatory requirements and guidance’s regarding content for various documents and apply this knowledge to the development of submission documents. Ensure document content and style comply with appropriate regulatory requirements. Demonstrate knowledge of and prepare documents in accordance with Covance/client SOPs and specifications as applicable, and relevant regulations and guidance’s. Assist in the development and management of formats, templates and general guidelines for clinical documents, including protocols and reports. Assist in the development and maintenance of Medical Writing SOPs. Effectively manage multiple assignments in parallel, ensuring adherence to quality, timelines, and budget requirements. Maintain knowledge of developments in Medical Writing. Provide peer review and input on deliverables prepared by colleagues. Provide scientific leadership and support to colleagues in the Data Management and reporting team. Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences.

 Education/Qualifications:Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., Ph D or Masters) preferred. Experience:

 

Minimum Qualifications Required:  Minimum 6 years medical writing experience, including three years as medical writing project lead.

Minimum Required: Ability to understand and correctly interpret clinical and scientific data; ability to present data to meet key messages constructed by the clinical, regulatory, and/or marketing teams. Ability to interact effectively on cross-functional teams and be able to proactively facilitate effective information exchange/communication including problem solving and issue resolution. Knowledge of and ability to apply applicable regulatory requirements and guidelines regarding clinical research. Advanced knowledge of medical devices, medical terminology, regulatory submissions, data presentation and statistical methodology preferred. Excellent understanding of medical/scientific terminology, data analysis and interpretation. Strong working knowledge of MS Word, MS Excel, MS PowerPoint and citation management software, i.e., ProCite, EndNote. Excellent organizational and time management abilities.

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Job posted: 2020-12-21

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