Job Details

Overview

Senior/Principal Medical Writer - Regulatory - Sponsor Dedicated - CMH Experience (Home-based, US or Canada)

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, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

WORK HERE MATTERS EVERYWHERE

Responsibilities

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.
• Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
• Develops good working relationships with internal and external colleagues.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develops or supports a variety of documents that include but not limited to: clinical study protocols and amendments; clinical study reports; patient narratives; clinical development plans; IND submissions and annual reports; integrated summary reports; NDA and (e)CTD submissions; investigator brochures; and clinical journal manuscripts, abstracts, and client presentations.
• Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
• Serves as peer reviewer to provide clear, accurate, and relevant comments to meet client objectives and maintain quality standards.
• Adheres to regulatory standards (including ICH-E3), SOPs, client standards, and templates; ensures on-time and on-budget medical writing projects.
• Performs online clinical literature searches as applicable.
• Continues professional development to stay aligned with regulatory guidance and client expectations that affect medical writing.
• Understands budget specifications for assigned projects and communicates changes to medical writing leadership within budgeted hours.
• Completes required administrative tasks within specified timeframes.
• Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
• Extensive knowledge of English grammar with familiarity with AMA style guide.
• Understanding of FDA and ICH regulations and guidelines strongly preferred.
• Demonstrated effective presentation, proofreading, and interpersonal skills with a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Familiarity with principles of clinical research and ability to interpret and present clinical data and other complex information.

Benefits

At Syneos Health, we provide an environment and culture in which Our People can thrive, develop and advance. Benefits may include a company car or car allowance, health benefits (medical, dental, vision), 401k with company match, eligibility to participate in Employee Stock Purchase Plan, potential eligibility for performance-based compensation, and flexible PTO and sick time. Paid time off policies vary by location in compliance with applicable laws.

Salary Range

$95,000.00 - $175,700.00