Overview
sr medical writer (drug development/late phase exp)
syneos health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our clinical development model centers the customer and the patient in everything we do. Whether you join us in a functional service provider partnership or a full-service environment, you’ll collaborate with passionate problem solvers to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies and improve lives.
Responsibilities
mentors and leads less experienced medical writers on complex projects, as necessary.
Acts as lead for assigned writing projects.
Manages medical writing activities associated with individual studies, coordinating activities within and across departments with minimal supervision.
Develops or supports a variety of documents that include, but are not limited to:
clinical study protocols and clinical protocol amendments
clinical study reports
patient narratives
clinical development plans
ind submissions and annual reports
integrated summary reports
nda and (e)ctd submissions
investigator brochures
clinical journal manuscripts, abstracts, and client presentations
identifies and proposes solutions to resolve issues and questions arising during the writing process, including escalation as appropriate.
Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
Interacts with department head and staff in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Serves as peer reviewer on internal review teams, providing review comments on draft and final documents.
Adheres to regulatory standards, including ich-e3 guidelines, sops, client standards, and approved templates while completing projects on time and within budget.
Performs online clinical literature searches as applicable.
Maintains familiarity with current industry practices and regulatory requirements that affect medical writing.
Maintains awareness of budget specifications for assigned projects and communicates changes to medical writing leadership.
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 and fda and ich regulations and guidelines; familiarity with ama style guide.
Demonstrated independence with effective presentation, proofreading, interpersonal, and leadership skills and a team-oriented approach.
Strong proficiency in word, excel, powerpoint, email, and internet.
Ability to interpret and present clinical data and other complex information with familiarity with principles of clinical research.
Get to know syneos health
over the past 5 years, we have worked with 94% of all novel fda approved drugs, 95% of ema authorized products and over 200 studies across 73,000 sites and 675,000+ trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
Additional information
tasks, duties, and responsibilities as listed in this job description are not exhaustive. The company may assign other tasks at its discretion. Equivalent experience, skills, and/or education will be considered. The company will determine what constitutes equivalent qualifications. This description does not create a contract. The company is committed to compliance with applicable laws and to providing reasonable accommodations under the americans with disabilities act as appropriate.
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