Senior Medical Editor - Biostatistics Documents - statistical documents (Statistical Analysis P[...]

Senior Medical Editor – Biostatistics Documents (Statistical Analysis Plan, Blinding & Unblinding Plan)

Senior Medical Editor – Biostatistics Documents

role at

Syneos Health .

Syneos Health

is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs and commercial insights into outcomes.

Our Clinical Development model places the customer and the patient at the center of everything we do. We continuously simplify and streamline our work to make Syneos Health easier to work with and easier to work for. Whether you join in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovate as a team and help our customers achieve their goals.

Job Responsibilities

Maintain strong familiarity with FDA, EU and other relevant guidelines to ensure documents meet or exceed sponsor and regulatory requirements.

Represent the editorial group in medical writing, on study teams and in cross-departmental project teams as needed.

Monitor timelines and budgets for assigned projects and update the lead medical writer, project manager or supervisor if deliverables are at risk.

Provide technical support and expertise, conduct training of medical editing staff and mentor other writers.

Serve as project lead for complex and / or large medical writing projects, scheduling and leading team meetings, organising requirements and ensuring all information is distributed to the editorial team.

Provide feedback to the lead medical writer on the progress of the editorial process.

Copyedit assigned documents, applying correct grammar, punctuation, spelling and style following AMA Manual of Style or custom guidelines, and internal checklists.

Perform quality review of assigned documents to ensure accuracy.

Contribute to process improvement tools and policies affecting editorial work.

Manage assigned projects according to SOPs and client standards, on time and on budget.

May compile medical writing deliverables.

Benefits

Our benefit package may include a company car or car allowance, medical, dental and vision health benefits, 401(k) match, Employee Stock Purchase Plan eligibility, commissions / bonus based on performance and flexible paid time off (PTO). Eligibility for paid sick time may vary by state or municipality.

Salary Range

$62,000.00 – $108,600.00 per year. Actual salary will vary based on qualifications and experience.

Summary

Improves and ensures the quality of compliance for written deliverables through copyediting, quality review and document management. Provides advanced editorial guidance and technical expertise in regulatory and clinical documents, leads editorial teams for large deliverables, and mentors other editing staff.

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Marketing, Public Relations, and Writing / Editing

EEO Statement

The Company accepts applications from all qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, marital status, age or disability status. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate.

Additional Information

Tasks, duties and responsibilities listed are not exhaustive. The Company may assign other tasks or duties.

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