Sr. Medical Editor (Regulatory Documents + QC) - US Home based
Syneos Health/ inVentiv Health Commercial LLC, New York, NY, United States
Sr. Medical Editor (Regulatory Documents + QC) - US Home based
Job Responsibilities
Maintains strong 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.
Performs QC review of documents (e.g., clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents).
Verifies data in documents against the source tables, figures, and listings and formats tables.
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, acts as a mentor, advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards, and provides training to members of the global medical writing team in aspects relative to their roles.
Serves as 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 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 the editorial process.
Copy‑edits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style, various custom style guidelines, and established medical writing internal checklists and best practices.
Performs quality 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 medical writing deliverables.
Salary Range: $62,000.00 - $108,600.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
The benefits for this position may include a company car or car allowance, health benefits to include medical, dental and vision, company match 401k, eligibility to participate in the Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.
In all aspects, the company has obligations to equal opportunity and welcomes candidates with diversity. The 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.
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Job Responsibilities
Maintains strong 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.
Performs QC review of documents (e.g., clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents).
Verifies data in documents against the source tables, figures, and listings and formats tables.
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, acts as a mentor, advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards, and provides training to members of the global medical writing team in aspects relative to their roles.
Serves as 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 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 the editorial process.
Copy‑edits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style, various custom style guidelines, and established medical writing internal checklists and best practices.
Performs quality 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 medical writing deliverables.
Salary Range: $62,000.00 - $108,600.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
The benefits for this position may include a company car or car allowance, health benefits to include medical, dental and vision, company match 401k, eligibility to participate in the Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.
In all aspects, the company has obligations to equal opportunity and welcomes candidates with diversity. The 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.
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