Senior Medical Editor – Biostatistics & Statistical Documents
Location: USA – California – Remote
Job ID: 25104109
Updated: Today
Overview
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating clinical, medical affairs, and commercial success for global partners. With a strong presence across 110 countries and extensive experience supporting regulatory submissions, the organization is committed to delivering high-quality, compliant, and scientifically accurate documentation.
We are currently seeking a Senior Medical Editor specializing in Biostatistics and Statistical Documents, including the Statistical Analysis Plan (SAP) and Blinding/Unblinding Plans. This role focuses on enhancing scientific accuracy, editorial quality, and regulatory compliance.
Key Responsibilities
Ensure all assigned documents comply with FDA, EMA, and other global regulatory guidelines, along with internal SOPs and sponsor standards.
Represent the editorial function in cross-functional medical writing, project, and study teams.
Monitor project timelines, resource allocation, and budgets; proactively communicate risks to project managers or medical writing leads.
Provide technical guidance, mentorship, and training to medical editors and medical writers across global teams.
Serve as project lead for large, complex writing and editorial deliverables, coordinating internal meetings and ensuring consistent document standards.
Support medical writing projects by providing timely updates and editorial insights to lead medical writers.
Perform copyediting, including grammar, punctuation, spelling, consistency, and adherence to the AMA Manual of Style or sponsor-specific style guides.
Conduct quality reviews (QR) to ensure accuracy, completeness, and content integrity.
Contribute to developing editorial SOPs, process improvement tools, checklists, and best-practice guidelines.
Manage assigned deliverables on time, on budget, and in alignment with client expectations.
May support compilation of medical writing deliverables for regulatory submission packages.
Required Qualifications & Experience
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biostatistics, English, Communications, or a related scientific discipline.
Minimum 5–8 years of professional experience in medical editing, medical writing, or regulatory documentation within CRO, pharma, or biotech environments.
Strong working knowledge of statistical concepts, regulatory requirements, and documentation standards for SAPs and related statistical documents.
Demonstrated experience in quality review, scientific editing, and document management for complex clinical and regulatory deliverables.
Proficiency with AMA Manual of Style, MS Office, and editorial review systems.
Ability to manage multiple projects, communicate effectively with cross-functional teams, and lead editorial processes.
Experience mentoring junior editors and supporting global writing teams is highly desirable.
Compensation & Benefits
Salary Range: USD 62,000 – 108,600 (based on skills, qualifications, and experience).
Additional benefits may include: medical, dental, and vision coverage; company-matched 401(k); employee stock purchase plan; paid time off; sick leave as applicable; and other performance-based incentives.
Why Join Syneos Health
Exposure to large-scale global projects, including work with 94% of FDA-approved novel drugs in the past five years.
Comprehensive professional development with continuous training and growth pathways.
A culture centered on authenticity, inclusion, and employee well-being.
Opportunity to contribute to high-impact scientific and regulatory documentation supporting global clinical research.
Additional Information
This job description provides an overview of responsibilities and expectations but is not exhaustive. Equivalent experience or skills may be considered based on organizational discretion. Syneos Health is committed to equal opportunity employment and supports applicants requiring reasonable accommodations under ADA regulations.
Apply Now
If you are not ready to apply, you may join the Syneos Health Talent Network to stay informed about future opportunities.
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