Job Title: Medical Writer II
Location: [Not specified]
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We combine clinical, medical affairs, and commercial insights to deliver outcomes that meet modern market needs.
Global Reach: 29,000 employees across 110 countries
Mission: Bringing customers and patients to the center of everything we do
Culture: Agile, collaborative, inclusive, and driven to change lives
Work Philosophy: Work Here Matters Everywhere
Why Join Us
Career development and progression opportunities
Supportive leadership and engaged line management
Technical and therapeutic area training
Recognition programs and total rewards
Total Self Culture: A diverse and inclusive workplace where authenticity is valued
Job Responsibilities
Core Responsibilities
Lead the clear, accurate, and timely completion of medical writing deliverables
Ensure scientific information is presented clearly and in compliance with regulatory standards (ICH E3, FDA, client templates, AMA style)
Manage medical writing activities for individual studies with minimal supervision
Collaborate across departments (data management, biostatistics, regulatory, medical affairs)
Key Deliverables
Prepare, write, and review a wide range of documents, including:
Clinical study protocols, amendments, and reports
Patient narratives, annual reports, investigator brochures
Informed consents and plain language summaries
Periodic safety update reports (PSURs)
Clinical development plans, IND submissions, NDA/eCTD submissions
Integrated summary reports, journal manuscripts, posters, and abstracts
Additional Duties
Conduct clinical literature searches and ensure copyright compliance
Review statistical analysis plans and output for accuracy, grammar, and clarity
Perform peer review for internal teams to ensure quality and consistency
Mentor and guide less experienced medical writers
Provide technical support, training, and consultation across teams
Work within assigned project budgets
Required Qualifications
Bachelor’s degree in a relevant discipline (advanced degree preferred)
1–3 years of experience in clinical trial disclosure (mandatory)
Hands-on experience with clinical registries: CT.gov, CTIS, EUDRACT
Experience in disclosure and redaction activities
Prior client interaction experience
Necessary Skills
Strong knowledge of FDA, ICH regulations, and good publication practices
Proficiency in medical terminology and ability to interpret clinical data
Excellent English grammar and written communication skills
Familiarity with AMA Manual of Style
Proficiency in MS Office Suite
Strong project management, time management, and presentation skills
Excellent collaboration, proofreading, and interpersonal skills
Preferred Attributes
Ability to build strong client and cross-functional relationships
Proactive problem-solving and issue resolution skills
Capacity to lead complex projects independently
Willingness to continuously develop expertise in industry and regulatory requirements
Additional Information
Job tasks and responsibilities may evolve at the company’s discretion
Equivalent skills/experience will be considered in place of formal qualifications
Syneos Health complies with all applicable employment legislation, including ADA reasonable accommodations and EU Equality Directive requirements
About Our Impact
Worked with 94% of all Novel FDA Approved Drugs in the past 5 years
Supported 95% of EMA Authorized Products
Partnered on 200+ studies across 73,000 sites and 675,000+ patients
🔗 Learn more: www.syneoshealth.com
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