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, with a focus on simplifying and streamlining work to improve collaboration across Functional Service Provider partnerships or Full-Service environments. We are agile and driven to accelerate the delivery of therapies to change lives.
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
* We develop our people through career development, supportive management, training, peer recognition, and total rewards programs.
* We are committed to our Total Self culture — authentic and inclusive, with care for our people.
* We value diversity of thoughts, backgrounds, and perspectives to create a sense of belonging for all.
Responsibilities
* Mentor and lead less experienced medical writers on complex projects as needed.
* Act as lead for assigned writing projects and manage medical writing activities for individual studies across departments with minimal supervision.
* Develop or support a variety of documents, including:
o Clinical study protocols and amendments
o Clinical study reports
o Patient narratives
o Clinical development plans
o IND submissions and annual reports
o Integrated summary reports
o NDA and (e)CTD submissions
o Investigator brochures
o Clinical journal manuscripts, abstracts, and client presentations
* Identify and propose solutions to issues during the writing process, escalating as appropriate.
* Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
* Interact with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
* Serve as peer reviewer on internal review teams, providing comments on drafts and final documents.
* Adhere to regulatory standards (ICH-E3), SOPs, client standards, and approved templates; ensure on-time and on-budget delivery.
* Perform online literature searches as applicable and stay current with industry practices and regulatory guidelines affecting medical writing.
* Monitor budget awareness for assigned projects, work within budgeted hours, and communicate changes to leadership.
* Complete required administrative tasks within specified timeframes and perform other duties as assigned. Minimal travel may be required (less than 25%).
Qualifications
* Bachelor of Science with relevant writing experience, or Bachelor of Arts in Social Sciences, English, or Communications with relevant scientific/medical knowledge.
* Extensive knowledge of English grammar, FDA and ICH regulations/guidelines, and familiarity with AMA style guide.
* Strong independence with effective presentation, proofreading, interpersonal, and leadership skills; able to work in a team-oriented environment.
* Proficiency in Word, Excel, PowerPoint, email, and internet research.
* Familiarity with principles of clinical research and ability to interpret and present clinical data and other complex information.
Get to know Syneos Health
Over the past 5 years, we have collaborated with 94% of novel FDA approved drugs, 95% of EMA authorized products, and conducted 200+ studies across 73,000 sites and 675,000+ trial patients. No matter your role, you will be encouraged to challenge the status quo in a dynamic, global environment. Learn more about Syneos Health at the official site.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities listed are not exhaustive. The company may assign other tasks at its discretion. Equivalent experience, skills, and/or education will be considered. The company may modify responsibilities as needed. Any language herein complies with applicable laws in each country of operation, including the EU Equality Directive. The company is committed to the Americans with Disabilities Act, including reasonable accommodations where appropriate.
Summary
Strong medical writing skills with lead-authoring experience on regulatory documents. Ability to manage multiple deliverables in parallel while maintaining quality and meeting timelines. Opportunities for growth within a global team environment.
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