Job Title:
Senior Medical Writer (Project Management Experience)
Company: Syneos Health®
Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization that partners with clients to accelerate the development and delivery of therapies. With 29,000 employees in over 110 countries, the company is driven by a passion to change lives.
Core Values:
Total Self culture – authentic self-expression
Career development and progression
Diversity, equity, and inclusion
Innovation through collaboration
Why Join Syneos Health?
Work with 94% of FDA-approved novel drugs in the last 5 years
Be part of a global team delivering over 200 studies across 675,000+ patients
Access to extensive training, mentorship, and professional growth
Competitive benefits and recognition programs
Position Summary
As a Senior Medical Writer, you will manage and lead medical writing activities for clinical studies and regulatory documents. This includes writing and reviewing documents, leading teams, interacting with cross-functional departments, and ensuring regulatory compliance — all while meeting project timelines and budget constraints.
Key Responsibilities
Project Management & Leadership
Minimum 5 years of project management experience
Lead and mentor junior writers on complex projects
Act as lead writer on assigned projects
Handle team coordination and cross-department collaboration
Ensure on-time, on-budget delivery of high-quality documents
Medical Writing
Write, edit, and manage a range of scientific and clinical documents, including:
Clinical study reports (CSRs)
Protocols and amendments
Informed consents
Investigator brochures
Regulatory submissions (INDs, NDAs, eCTDs)
Safety reports (DSURs, PSURs)
Journal manuscripts, abstracts, posters
Review statistical analysis plans and outputs (tables, figures, listings) for consistency and accuracy
Perform clinical literature reviews and support regulatory agency interactions (e.g., briefing documents, response letters)
Process & Quality Management
Adhere to ICH, FDA, EMA guidelines and company/client SOPs
Review, update, or create internal guidance documents, SOPs, and training manuals
Serve as peer reviewer for other writers
Identify and resolve project-related issues
Maintain awareness of project budgets and timelines
Required Qualifications
Education
Bachelor of Science or
Bachelor of Arts in English, Communications, or Social Sciences with relevant medical/scientific experience
Skills & Experience
5+ years of experience in project management and medical writing
Team handling and leadership experience required
Strong knowledge of FDA/ICH regulations, AMA style guide, and clinical research principles
Proficiency in MS Office Suite (Word, Excel, PowerPoint)
Experience creating process maps using MS Visio or similar tools
Excellent written and verbal communication skills
Ability to analyze and present complex clinical data clearly
Experience managing writing activities across multiple departments
Additional Details
Remote/hybrid role (travel < 25%)
Work within project scope, timelines, and budget
Comply with company and regional legal guidelines (e.g., EU Equality Directive, ADA)
Other duties as assigned
Core Competencies
Scientific writing and editing
Cross-functional project coordination
Regulatory document preparation
Quality and peer review processes
Team leadership and mentorship
Budget and timeline awareness
Technical proficiency and document management
How to Apply
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