Principal Medical Editor

Job Description

Improves and ensures the quality of compliance or written deliverables through copyediting, data integrity review, document management, and publishing support. Provides advanced editorial guidance and technical expertise in the writing, production, review, or compilation and publishing of regulatory and other scientific/clinical documents. Serves as project lead for large deliverables requiring multiple editors or for stand-alone deliverables, ensuring internal timelines are met and communicating budget updates to the lead medical writer or client as applicable. Independently performs advanced quality review, compilation, and publishing tasks for medical writing deliverables to ensure content integrity and consistency with customer and/or regulatory submission standards. Interacts with department heads and staff members throughout the company regarding assigned deliverables as appropriate. Provides training and mentoring to other Medical Editing staff members.Job Responsibilities:Maintains excellent working knowledge of 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.Is responsible for tracking assigned projects and their budgets, liaising with Medical Writing management, and ensuring resources are assigned appropriately to each project.Provides advanced 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.Supports the development of process improvement tools specific to editorial staff and oversees 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.Critiques documents for readability and flow as well as wording and style continuity across a compound or submission.May compile and publish medical writing deliverables., *Qualifications RequirementMaster s degree in the life sciences, clinical sciences, or English/journalism; or in any other fieldMin 6 years experience in copyediting of scientific journals, regulatory documents, publication documents, brochures, CSR.Extensive relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; ISIToolbox experience preferred.Advanced proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).Excellent attention to detail, including extensive copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills. Advanced 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 strongly preferred.

Keyskills :
medical transcriptioneditingquality controlsettlementsadobe creative suitestandard operating proceduresama stylecopy editinglife sciencesadobe acrobatproject teamsiso standardsstatements of work sow