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Senior/Principal Medical Editor – FSP (Regulatory Documents)

サイネオス・ヘルス

77d ago

0$62k - $176kWritingPA, USjobspy_indeed
remoteindeed

Job Description

**Updated:** Yesterday **Location:** Remote, PA, United States **Job ID:** 25110995 Not ready to apply? Join our Talent Network **Description** Senior/Principal Medical Editor – FSP (Regulatory Documents) Syneos Health® is a leading fully\-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. **Job Responsibilities** * 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