Syneos Health is a leading global biopharmaceutical solutions organization, specializing in clinical and commercial outsourcing services. With a strong focus on accelerating customer success, Syneos Health integrates clinical development, medical affairs, and commercialization services to deliver innovative healthcare solutions.
The company is known for its collaborative work environment, career growth opportunities, and commitment to transparency in clinical research.
Detailed Job Description
Job Title: Medical Writer – I (Clinical Trial Transparency/Disclosure)
Location: Remote (Hiring office in India)
Experience: 1-4 years
Openings: 3
Key Responsibilities:
- Authoring & Quality Assurance:
- Prepare and edit clinical trial disclosure documents (e.g., Protocol Registration Form, Results Registration Form) for platforms like ClinicalTrials.gov and other registries.
- Ensure compliance with US FDA, EU CTR, and other regulatory requirements.
- Perform quality checks on documents to maintain accuracy and adherence to SOPs.
- Clinical Trial Documentation:
- Interpret clinical study protocols and reports for disclosure purposes.
- Draft regulatory submission documents, including Clinical Study Reports (CSR), patient narratives, and clinical summaries.
- Training & Mentorship:
- Assist in training junior team members.
- Stay updated on clinical trial disclosure regulations and best practices.
Preferred Skills & Experience:
- 1-4 years of medical writing experience, preferably in clinical trial disclosure (CTT).
- Experience with Protocol Registration, Results Posting, and Redaction (added advantage).
- Familiarity with ClinicalTrials.gov (CT.gov), EU CTR, and FDA requirements.
- Strong scientific writing, attention to detail, and ability to work in a fast-paced environment.
Eligibility & Qualifications
- Master’s degree in Life Sciences, Pharmacy, Medicine, or related field.
- Prior experience in clinical trial transparency, regulatory writing, or medical communications.
- Excellent written and verbal communication skills.
Benefits of Working at Syneos Health
✅ Remote Work Flexibility
✅ Competitive Salary & Growth Opportunities
✅ Exposure to Global Clinical Trials & Pharma Clients
✅ Training & Career Development Programs
How to Apply
