Medical Editor II – (19006968)
Improves and ensures the quality of compliance or written deliverables through copyediting, data integrity review, document management, and publishing support. May independently perform quality review, compilation, or 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.
- 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.
- 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.
- 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.
- Bachelor’s degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience.
- Relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred. ISIToolbox experience preferred.
- 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.
- 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.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Primary Location: North America – US Home-Based
Job: Medical Affairs
Employee Status: Regular
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.