Role & responsibilities

Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.
Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed.
Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards. Provides training to members of the global Medical Writing team in aspects relative to their roles.
Project lead for deliverables of assigned complex and/or large medical writing projects, including but not limited to scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring that all information is distributed to the editorial team and implemented within the deliverable.
Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of document editorial process.
Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following American Medical Association (AMA) or various custom style guidelines as well as established medical writing internal checklists and best practices.
Performs data integrity review of assigned documents to ensure accuracy.
Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
May compile and publish medical writing deliverables.

Qualifications

Bachelors degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience.
Significant relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; ISIToolbox experience preferred.
Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
Excellent attention to detail, including strong copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills.
Excellent grammatical and communication skills, both written and oral.
Extensive familiarity with the AMA style guide strongly preferred.
Ability to work with minimal supervision on multiple assignments with set deadlines.
Ability to work independently as well as part of a team and keep others informed of the progress and status of projects.
Adaptable to changes in work duties, responsibilities, and requirements.
Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred.

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