Medical Writer

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Roles and ResponsibilitiesUnder departmental supervision, the Medical Writer will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities, including but not limited to: study protocols, model informed consents, interim and final clinical study reports, and safety update reports.The Medical Writer will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission.Medical writers primary responsibility is to communicate complex medical information in clear and compliant writing. The Medical Writer must ensure all deliverables are in accordance with regulations, standards, and guidelines. The regulatory documents that the Medical Writer prepares must meet ICH, GLPs, and GCPs guidelines, a writing style guide, and company template. The Medical Writer must understand the levels of evidence required to achieve regulatory, clinical, operational, and marketing goals.Essential Job Functions: Medical writer will be responsible for the following:Partner with clinical teams to understand the nature of the scientific work that they will be covering.Conduct comprehensive literature searches to enhance their background understanding, then evaluate, analyze, and apply to clinical documents.Compile, write, and edit medical writing deliverables covering all phases of clinical research for submission to regulatory agencies.Deliver clinical documents including comprehensive clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.Manage assigned writing projects.Attend meetings and support assigned therapeutic area publication team in manuscript and/or publications submissions to scientific meetings, medical journals.Manage document development timelines to facilitate timely submission. Job Requirements:Medical Writer must be aware of current industry practices and regulatory requirements that affect medical writing. They must keep abreast of current literature, emerging science, technological developments, and medical trends.Ability to learn and recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in document types under supervision.Leadership skills, both in time management as well as in project/process managementAble to resolve basic problems independently and complex problems under supervision.Familiarity with relevant publication, industry, and regulatory document guidance and best practicesAbility to build solid and positive relationships with cross-functional team members.Learning agility and attention to detail.Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.Extensive clinical/scientific writing skills.Scientific background essential; writing experience includes multiple clinical study reports.Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).Willingness to work in a matrix environment, values the importance of teamwork, and understands roles of other project team members. Possesses team leadership skills and cross-cultural sensitivity.This job is provided by Shine.com