Medical Editor in Orpington

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.

Why Syneos Health

We are passionate about developing our people, through career development and progression; technical and therapeutic area training; peer recognition and total rewards program. 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.

Job Responsibilities

• Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision.
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
• Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained.
• Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Interacts and builds good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
• Performs online clinical literature searches and complies with copyright requirements.
• Mentors and leads less experienced medical writers on complex documents.
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
• Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership.
• Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects.

Min/Preferred Education Level Description

Minimum 4 Year / Bachelors Degree in a relevant discipline with relevant writing experience; graduate degree preferred.

Additional Qualifications

• At least 6 years of relevant experience in science, technical, or medical writing.
• Extensive experience working in the biopharmaceutical, device, or contract research organization industry required.
• Extensive experience writing relevant document types required.
• Extensive knowledge of English grammar and able to communicate clearly; strong familiarity with AMA Manual of Style.

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.

Summary

Principal medical writer on clinical study or regulatory project teams. Provides scientific writing, regulatory guidance, and technical expertise in the writing, production, and review of high-quality complex regulatory and other scientific/clinical documents, ensuring that clinical data is presented in documents in compliance with applicable regulatory guidelines.