Job Title:
Senior Medical Editor (Regulatory)
Company:
Syneos Health
Location:
India-Asia Pacific - Home-Based, India
Job ID:
25002456
Job Type:
Full-Time
Role Overview:
The Senior Medical Editor will be responsible for ensuring medical documents meet regulatory standards and guidelines. This role involves managing large, complex projects, mentoring medical editing staff, and leading the editorial aspects of regulatory submissions and medical writing projects.
Key Responsibilities:
Regulatory Compliance & Editing:
Ensure documents comply with FDA, EU, and other relevant regulatory guidelines.
Provide editing support to medical writing teams, ensuring correct grammar, punctuation, and adherence to AMA or custom style guidelines.
Conduct data integrity reviews for assigned documents.
Project Management:
Lead editorial teams for complex medical writing projects.
Monitor timelines, budgets, and deliverables, ensuring they are met within scope and schedule.
Organize internal meetings, ensuring all project-specific requirements are communicated to the editorial team.
Training & Mentorship:
Train and mentor junior medical editors and writers.
Advise teams on editorial standards and best practices.
Contribute to the development of process improvement tools and internal policies.
Process & Quality Control:
Ensure all editorial work is completed on time and adheres to client and internal standards.
Contribute to process improvement initiatives and assist in revising internal editorial procedures.
Requirements:
Education:
Bachelor’s degree (preferred) in life sciences, clinical sciences, English/journalism, or relevant publishing experience.
Experience:
Significant experience in publishing, medical editing, and/or regulatory documentation.
Familiarity with publishing tools like Adobe Acrobat, ISIToolbox, and proficiency in MS Office Suite (Word, Excel, PowerPoint).
Skills:
Strong editing, data integrity review, and organizational skills.
Excellent grammatical and communication skills.
Knowledge of FDA, EU regulations, ICH standards, and ISO guidelines for regulatory documents.
Ability to manage multiple projects with minimal supervision.
Why Syneos Health?
Employee Development: Syneos Health offers career progression opportunities, technical and therapeutic training, and a supportive work environment.
Global Culture: The company values diversity and promotes a "Total Self" culture where employees can thrive and be their authentic selves.
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