Senior/Principal Medical Editor – FSP, Regulatory Documents

This is a fully remote position, open to applicants in United States.

📋 Description

• Maintain a comprehensive understanding of FDA, EU, and other pertinent guidelines and industry standards to ensure documents comply with sponsor and regulatory requirements.

• Act as a representative of the editorial group in medical writing, study teams, and cross-departmental project teams.

• Oversee timelines and budgets for assigned projects, notifying relevant stakeholders if deliverables are at risk.

• Provide technical support and expertise as needed.

• Train and mentor staff involved in medical editing.

• Offer guidance to medical writers, medical editors, and study teams on quality review, compilation, and editorial standards.

• Educate global medical writing team members on role-specific aspects.

• Lead deliverables for intricate and/or sizable medical writing projects.

• Schedule and facilitate internal project-specific team meetings.

• Organize project-specific requirements, ensuring information is shared with and implemented by the editorial team.

• Participate in medical writing teams for projects requiring medical writing deliverables.

• Provide progress feedback to the lead medical writer.

• Edit assigned documents for grammar, punctuation, spelling, and style in accordance with the AMA Manual of Style, custom style guidelines, checklists, and best practices.

• Conduct quality reviews of assigned documents for accuracy.

• Contribute to the development of process improvement tools and internal editorial policies and procedures.

• Manage assigned projects in line with medical writing SOPs and client standards, ensuring they are completed on time and within budget.

• Compile medical writing deliverables as necessary.

⛳️ Requirements

• Strong understanding of FDA, EU, and other relevant regulatory guidelines and industry standards.

• Proficiency in applying the AMA Manual of Style and custom style guidelines.

• Experience in medical writing, medical editing, quality review, and document compilation.

• Capability to manage complex and/or large medical writing projects.

• Ability to monitor project timelines and budgets effectively.

• Skills to provide technical support and train or mentor medical writing and editing staff.

• Familiarity with adhering to medical writing standard operating procedures and client standards.

• Equivalent experience, skills, and/or education will also be considered.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive total rewards program.

• An inclusive culture.

• Company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on company and individual performance.

• Flexible paid time off (PTO).

• Sick time.

• Reasonable accommodations, when appropriate.