Sr Medical Writer

Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

Join to apply for the Sr Medical Writer (Must Have - Drug Development & Late Phase Exp) role at Syneos Health

Overview

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, and we collaborate to simplify and streamline work across Functional Service Provider partnerships or Full-Service environments. We are agile and driven to accelerate the delivery of therapies and change lives.

WORK HERE MATTERS EVERYWHERE

Job Responsibilities

• Mentor and lead less experienced medical writers on complex projects as necessary.
• Act as lead for assigned writing projects.
• Manage medical writing activities for individual studies, coordinating activities across departments with minimal supervision. Develop or support documents including 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; clinical journal manuscripts and abstracts; client presentations.
• Identify and propose solutions to resolve issues during the writing process, including escalation 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 writing deliverables.
• Serve as peer reviewer on internal review teams, providing comments on drafts and final documents.
• Adhere to regulatory standards (including ICH-E3), SOPs, client standards, and approved templates; deliver projects on time and on budget.
• Perform online clinical literature searches as applicable.
• Maintain familiarity with current industry practices and regulatory guidelines affecting medical writing.
• Maintain awareness of budget specifications for assigned projects, working within budgeted hours and communicating changes to medical writing leadership.
• Complete required administrative tasks within specified timeframes.
• Perform other duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

• Bachelor of Science in a relevant field or Bachelor of Arts (Social Sciences, English or Communications) with relevant scientific/medical knowledge.
• Extensive knowledge of English grammar and FDA/ICH regulations and guidelines; familiarity with AMA style guide.
• Demonstrated independence with strong presentation, proofreading, interpersonal, and leadership skills; team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to interpret and present clinical data and other complex information.

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 your role, you'll take the initiative and challenge the status quo in a dynamic environment. Learn more at www.syneoshealth.com.

Additional Information

• Tasks, duties, and responsibilities are not exhaustive. The company may assign other tasks at its discretion. Equivalency of experience/skills will be considered. Nothing herein creates an employment contract.
• Compliance with applicable laws, including the EU Equality Directive and the Americans with Disabilities Act, with reasonable accommodations when appropriate.

Summary

Strong medical writing skills with lead-authoring experience on various drug regulatory documents. Ability to manage multiple deliverables in parallel while maintaining quality and meeting timelines. Opportunities for growth in a global team environment.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Marketing, Public Relations, and Writing/Editing

Industries

• Biotechnology Research
• Pharmaceutical Manufacturing
• Research Services

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