Senior Medical Writer
4 weeks ago
As a Senior Medical Writer at Syneos Health, you will be responsible for creating high-quality medical content for various projects. This includes developing clinical study protocols, clinical study reports, patient narratives, and other documents. You will work closely with cross-functional teams to ensure that all content meets regulatory standards and is delivered on time.
Key Responsibilities
- Mentor and lead less experienced medical writers on complex projects.
- Act as lead for assigned writing projects.
- Manage medical writing activities associated with individual studies, coordinating with departments with minimal supervision.
- Develop or support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and more.
- Identify and propose solutions to resolve issues and questions arising during the writing process.
- Review statistical analysis plans and table/figure/listing specifications for appropriate content and grammar.
- Interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary.
- Serve as peer reviewer on internal review team providing review comments on draft and final documents.
- Adhere to established regulatory standards, including ICH-E3 guidelines, and Company Standard Operating Procedures.
- Maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
- Maintain awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
Requirements
- 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 and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
About Syneos Health
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
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