Medical Writer Lead
hace 4 semanas
Job Summary
As a Medical Writer Lead at Syneos Health, you will be responsible for mentoring and leading less experienced medical writers on complex projects. You will act as the lead for assigned writing projects, managing medical writing activities associated with individual studies, and coordinating with departments with minimal supervision. Your expertise will be utilized to develop or support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and more. You will also identify and propose solutions to resolve issues and questions arising during the writing process. Your strong proficiency in Word, Excel, PowerPoint, and email will be essential in completing tasks efficiently. Additionally, you will maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing. If you have a Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree with relevant scientific and/or medical knowledge and expertise, we encourage you to apply. We are committed to building a diverse, inclusive, and authentic workplace where everyone feels like they belong. Join us in our mission to accelerate customer success and improve patients' lives around the world.
About the Role
This is a challenging and rewarding role that requires strong leadership and writing skills. As a Medical Writer Lead, you will be responsible for leading a team of medical writers and ensuring that all writing projects are completed on-time and on-budget. You will work closely with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce high-quality writing deliverables. Your expertise in clinical research and ability to interpret and present complex information will be essential in this role. If you are a motivated and detail-oriented individual with a passion for medical writing, we encourage you to apply.
Responsibilities
Mentors and leads less experienced medical writers on complex projects
Acts as lead for assigned writing projects
Manages medical writing activities associated with individual studies, coordinating with departments with minimal supervision
Develops or supports a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and more
Identifies and proposes solutions to resolve issues and questions arising during the writing process
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
Interacts with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce high-quality writing deliverables
Serves as peer reviewer on internal review team providing review comments on draft and final documents
Adheres to established regulatory standards, including ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects
Performs on-line clinical literature searches, as applicable
Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing
Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership
Completes required administrative tasks within the specified timeframes
Performs other work-related duties as assigned
Requirements
Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree with relevant scientific and/or medical knowledge and expertise
Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as 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 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. Together, we share insights, use the latest technologies, and apply advanced business practices to speed our customers' delivery of important therapies to patients. We support a diverse, equitable, and inclusive culture.
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