Overview

Sr Medical Writer, Regulatory (Home-based, US and Canada) — Description: Senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory documents while serving as the primary technical contact with the internal team and the client.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of client comments.
• Completes documents such as clinical study protocols and amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summaries, NDA/eCTD submissions, journal manuscripts, abstracts, posters, and presentations for scientific meetings.
• Adheres to regulatory standards (ICH E3 and guidelines), SOPs, client standards, and approved templates, authorship requirements, and style/formatting guides, delivering on time and on budget.
• Coordinates quality and editorial reviews. Ensures source documentation is properly managed. Leads team document reviews and reviews documents as needed.
• Acts as peer reviewer to ensure scientific content, clarity, and formatting; reviews statistical analysis plans and table/figure/listing specifications for content, grammar, and consistency.
• Interacts with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions, escalates appropriately, provides technical support and training, and may contribute to internal materials and process improvements.
• Mentors and leads less experienced medical writers on complex projects; develops deep expertise on topics and regulatory guidelines affecting medical writing.
• Works within budget specifications, communicates status and changes to medical writing leadership, and completes required administrative tasks within timeframes.
• Minimal travel may be required (less than 25%).

Qualifications

• Bachelor of Science with relevant writing experience 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.
• Experience writing relevant document types; demonstrated independence with strong communication, proofreading, leadership, and teamwork skills.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet; ability to interpret and present clinical data.

Compensation and Benefits

Salary Range: $80,600.00 - $145,000.00

The base salary range is the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, and proficiency for the role. Benefits may include health benefits (medical, dental, vision), 401(k) with company match, eligibility for Employee Stock Purchase Plan, paid time off, and other company-specific programs. Eligibility for paid sick time varies by location.

About Syneos Health

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. We are agile and driven to accelerate the delivery of therapies and change lives. Our 29,000+ employees across 110 countries work to simplify and streamline our work, supporting customers worldwide.

Additional Information

Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign other tasks at any time. The Company may consider equivalent experience, skills, and/or education. This description is intended to comply with applicable laws and includes reasonable accommodations during the recruitment and employment process as required by law.