Syneos Health is hiring for the position of Medical Writer I (Project Specialist) for a remote/home-based role in India. This opportunity is ideal for candidates with 1–2 years of experience in eTMF filing, document management systems, and Veeva platforms, along with a strong understanding of GxP guidelines and regulatory documentation practices.
Syneos Health is one of the world’s leading biopharmaceutical solutions organizations, operating across 110 countries with more than 29,000 employees. The company plays a significant role in clinical development, having supported 94% of novel FDA-approved drugs and 95% of EMA-authorized products in the last five years.
Candidates with life science backgrounds such as B.Pharm, M.Pharm, Pharm.D, Biotechnology, Clinical Sciences, or related fields who are interested in medical writing, regulatory documentation, and clinical trial documentation management are encouraged to apply.
Job Details
- Position: Medical Writer I (Project Specialist)
- Company: Syneos Health
- Job Type: Full-time
- Work Mode: Remote / Home-based
- Shift Timing: 12 PM – 9 PM
- Location: India (Remote) / Gurugram Hybrid Option
- Experience Required: 1–2 Years
- Industry: Clinical Research / Medical Writing / Regulatory Documentation
Key Responsibilities
The Medical Writer I (Project Specialist) will support document management and regulatory filing activities within clinical development programs.
Key responsibilities include:
- Perform eTMF filing and document management in accordance with project requirements.
- Work within Veeva RIM / Veeva Clinical systems for accurate document classification and storage.
- Ensure proper metadata validation, naming conventions, and filing structures for regulatory documents.
- Upload and manage project documents within Veeva platforms, ensuring compliance with GxP guidelines.
- Track project documentation and maintain updated records for efficient retrieval.
- Maintain strict adherence to regulatory and sponsor requirements.
- Participate in internal and client meetings to address document management issues.
- Monitor project timelines and escalate potential delays to project managers or lead medical writers.
- Support development and improvement of process workflows and SOPs.
- Maintain knowledge of FDA, EU, ICH guidelines, and global regulatory standards.
Eligibility Criteria
Educational Qualification
Candidates must have:
- Bachelor’s degree in Life Sciences or Clinical Sciences
Examples include: - B.Pharm
- M.Pharm
- Pharm.D
- BSc / MSc Life Sciences
- Biotechnology / Clinical Research
- Related scientific disciplines
Experience Required
Applicants should have:
- 1–2 years experience in eTMF filing or document management systems
- Hands-on experience with Veeva RIM / Veeva Clinical platforms
- Knowledge of GxP guidelines and regulatory documentation practices
Required Skills
Strong candidates for the Medical Writer job at Syneos Health should possess:
- Excellent written and verbal English communication skills
- Strong attention to detail and document accuracy
- Knowledge of clinical documentation and regulatory submission processes
- Ability to work with multiple assignments and deadlines
- Familiarity with FDA, EU regulatory requirements, ICH guidelines, and ISO standards
- Proficiency in Microsoft Word, Excel, and PowerPoint
Benefits of Working at Syneos Health
Employees at Syneos Health receive several professional and career benefits:
- Global exposure to clinical development and regulatory documentation projects
- Opportunity to work with top pharmaceutical and biotech companies
- Remote work flexibility
- Strong career development and technical training programs
- Collaborative and diverse global working environment
Why This Medical Writing Role is Valuable
Medical writing and document management professionals are critical to the clinical trial ecosystem. Accurate eTMF filing, regulatory documentation, and compliance with global guidelines ensures that clinical studies remain inspection-ready and regulatory submissions meet approval requirements.
This role offers an excellent pathway for professionals interested in careers in:
- Medical Writing
- Regulatory Affairs
- Clinical Documentation Management
- Clinical Trial Operations
How to Apply
