Senior/Principal Medical Editor – FSP, Regulatory Documents

🔥 28 minutes ago

🇺🇸 United States – Remote

💵 $62k - $175.7k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Maintain strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure documents meet sponsor and regulatory requirements • Represent the editorial group in medical writing, study teams, and cross-departmental project teams • Monitor timelines and budgets for assigned projects and alert relevant stakeholders when deliverables are at risk • Provide technical support and expertise • Train and mentor medical editing staff • Advise medical writers, medical editors, and study teams on quality review, compilation, and editorial standards • Train global medical writing team members in role-relevant aspects • Lead deliverables for complex and/or large medical writing projects • Schedule and lead internal project-specific team meetings • Organize project-specific requirements and ensure information is distributed to and implemented by the editorial team • Serve on medical writing teams for projects with medical writing deliverables • Provide progress feedback to the lead medical writer • Copyedit assigned documents for grammar, punctuation, spelling, and style using AMA Manual of Style, custom style guidelines, checklists, and best practices • Perform quality review of assigned documents for accuracy • Contribute to process improvement tools and internal editorial policies and procedures • Manage assigned projects according to medical writing SOPs and client standards, on time and on budget • Compile medical writing deliverables as needed

🎯 Requirements

• Strong familiarity with FDA, EU, and other relevant regulatory guidelines and industry standards • Ability to apply AMA Manual of Style and custom style guidelines • Experience with medical writing, medical editing, quality review, and document compilation • Ability to manage complex and/or large medical writing projects • Ability to monitor project timelines and budgets • Ability to provide technical support and train or mentor medical writing and editing staff • Ability to follow medical writing standard operating procedures and client standards • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time • Reasonable accommodations, when appropriate