Sr Medical Editor, Regulatory (Home-based, East Coast of US)
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. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
* 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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
* We are continuously building the company we all want to work for and our customers want to work with. Why? 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.
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 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.
Benefits and compensation
Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Benefits for this position may include a company car or car allowance, health benefits (medical, dental, vision), 401(k) with company match, 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. Eligibility for paid sick time may vary depending on location; Syneos complies with applicable paid sick time requirements.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Marketing, Public Relations, and Writing/Editing
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