Senior Medical Editor – Biostatistics & Statistical Documents
Location: USA – Mississippi – Remote
Job ID: 25104109
Updated: Today
About Syneos Health
Syneos Health is a global, fully integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercialization. With operations in more than 110 countries, the company partners with pharmaceutical, biotechnology, and medical device organizations to accelerate the delivery of therapies to patients.
The Clinical Development model places customers and patients at the center, emphasizing quality, compliance, operational efficiency, and scientific excellence. The organization values innovation, collaboration, and continuous improvement across all functional areas.
Position Summary
The Senior Medical Editor will provide expert editorial support for biostatistics-driven documents, including Statistical Analysis Plans (SAPs) and Blinding/Unblinding Plans. The role ensures accuracy, regulatory compliance, style consistency, and document integrity across complex clinical and statistical deliverables. This position also involves mentoring editorial staff, leading document-specific editorial teams, and collaborating closely with global medical writing groups.
Key Responsibilities
Interpret and apply FDA, EMA, and global regulatory guidelines to ensure all documents meet compliance and industry standards.
Represent the editorial function within study teams and cross-functional project groups.
Track and monitor project timelines, budgets, and deliverables; proactively report risks to project managers or writing leads.
Provide mentorship, training, and editorial guidance to medical writers and editors across global teams.
Lead editorial activities for large, complex writing projects, including meetings, workflow coordination, and requirement management.
Support medical writing deliverables by offering structured feedback on editorial progress to lead medical writers.
Perform copyediting using AMA Manual of Style and/or sponsor-specific guidelines.
Execute quality reviews (QR) ensuring scientific accuracy, formatting consistency, clarity, and submission readiness.
Contribute to development and continuous improvement of editorial SOPs, checklists, and best-practice tools.
Manage assigned projects according to internal SOPs and client standards, ensuring delivery on schedule and within budget.
May support compilation of regulatory submission packages and related documentation.
Required Qualifications & Experience
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, English, Biomedical Writing, Biostatistics, or related discipline.
Minimum 5–8 years of experience in medical editing, medical writing, or regulatory documentation within CRO, pharma, or biotech.
Demonstrated expertise in reviewing statistical documents, including SAPs, data handling plans, and related biostatistics deliverables.
Strong understanding of statistical terminology, clinical trial methodology, regulatory expectations, and submission requirements.
Advanced proficiency in AMA Manual of Style, editorial review processes, and Microsoft Office tools.
Proven ability to lead multiple editorial projects simultaneously in a fast-paced environment.
Experience mentoring junior team members and collaborating with cross-functional global project teams.
Compensation & Benefits
Salary Range: USD 62,000 – 108,600
(Salary varies based on experience, skills, and job proficiency.)
Potential benefits include:
Medical, dental, and vision coverage
Company car or car allowance (based on role eligibility)
Company-matched 401(k)
Employee Stock Purchase Plan
Performance-based incentive programs
Flexible paid time off (PTO) and sick leave, subject to state regulations
Why Work at Syneos Health
Opportunity to contribute to work supporting 94% of FDA-approved novel drugs in the past 5 years.
Strong focus on employee growth, training, coaching, and technical development.
Inclusive workplace built on the company’s Total Self culture, encouraging authenticity and diversity.
Global exposure to complex scientific, clinical, and regulatory documentation projects.
Additional Information
This job description reflects primary responsibilities and qualifications but is not exhaustive. Additional tasks may be assigned based on business needs. Equivalent education or experience may be considered. Syneos Health complies with all applicable federal and state employment regulations, including ADA accommodation guidelines.
Apply Now
Candidates may apply directly or join the Syneos Health Talent Network to stay updated on future opportunities.
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