Regulatory Medical Writer - Home Based

Senior Medical Editor - Regulatory - Home Based
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

technical and therapeutic area training; We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.

• Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed.
• Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
• Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles.
• Serves as project lead for deliverables of assigned complex and/or large medical writing projects, including, but not limited to, scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is distributed to the editorial team and implemented within the deliverable.
• Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process.
• Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices.
• Performs quality review of assigned documents to ensure accuracy.
• Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
• Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
• May compile medical writing deliverables.

We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Further, nothing contained herein should be construed to create an employment contract. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Improves and ensures the quality of compliance of written deliverables through copyediting, quality review, and document management. Provides advanced editorial guidance and technical expertise in the writing, production, and/or review of regulatory and other scientific/clinical documents. Independently performs advanced quality review or compilation tasks for medical writing deliverables to ensure content integrity and consistency with customer and/or regulatory submission standards. Interacts with medical writing leadership and staff regarding assigned deliverables as appropriate. Provides training and mentoring to other medical editing staff members.