Medical Writer I (Project Specialist) –
- Syneos Health Hiring Medical Writer I (Project Specialist) – Clinical Documentation & eTMF Specialist | Gurgaon Hybrid Opportunity
- Company Overview
- Job Role and Responsibilities
- Eligibility and Qualifications
- Required Education
- Experience
- Required Skills
- Preferred Knowledge
- Location and Salary
- Application Process
- Frequently Asked Questions
- What does a Medical Writer I (Project Specialist) do?
- What qualifications are required for this job?
- What experience is required?
- What tools should candidates be familiar with?
- Is the job remote or office based?
- Job Summary
Syneos Health Hiring Medical Writer I (Project Specialist) – Clinical Documentation & eTMF Specialist | Gurgaon Hybrid Opportunity
Syneos Health is currently recruiting for the position of Medical Writer I (Project Specialist) within its Medical and Scientific Affairs team. This role is based in Gurgaon, Haryana, with a hybrid working model and home‑based flexibility. The vacancy is ideal for life sciences graduates who have 1–2 years of experience in clinical trial documentation, eTMF filing, regulatory document management, or Veeva systems within the pharmaceutical or CRO industry.
The Medical Writer I role focuses on managing clinical and regulatory documents, maintaining electronic Trial Master Files (eTMF), supporting regulatory compliance activities, and ensuring proper documentation standards within global clinical research programs. Professionals working in this position will collaborate with project managers, clinical research teams, and regulatory stakeholders to ensure accurate document filing and adherence to global regulatory standards such as GxP, ICH guidelines, and FDA or EU regulatory frameworks.
For professionals seeking careers in medical writing, clinical documentation management, regulatory affairs support, or clinical trial operations, this position offers valuable exposure to global pharmaceutical research and CRO project environments.
Company Overview
Syneos Health is a leading global biopharmaceutical solutions organization that integrates clinical development, medical affairs, and commercialization services to help pharmaceutical and biotechnology companies accelerate the development of innovative therapies.
With more than 29,000 employees operating across over 110 countries, Syneos Health supports sponsors through the entire drug development lifecycle, from early clinical research to regulatory approvals and commercialization strategies. The company has played a role in supporting the development of a significant percentage of newly approved medicines across the United States and Europe.
Syneos Health combines clinical research expertise with real‑world medical insights to improve patient access to innovative treatments. The organization collaborates with global pharmaceutical companies, biotech firms, and healthcare stakeholders to ensure clinical trials and regulatory documentation meet the highest standards of quality and compliance.
The company promotes a culture of collaboration, innovation, and professional growth. Employees receive continuous learning opportunities, career development programs, and training in therapeutic areas and clinical research technologies.
Job Role and Responsibilities
The Medical Writer I (Project Specialist) will support document management and electronic filing activities within the Veeva Clinical and Veeva RIM platforms. The role requires strong attention to detail, knowledge of eTMF processes, and the ability to manage clinical trial documentation in accordance with regulatory standards.
Key responsibilities include:
- Managing document filing activities within Veeva Clinical or Veeva RIM systems according to project requirements
- Performing eTMF filing and maintaining structured document management processes
- Ensuring documents are correctly categorized based on metadata, versions, and filing structures
- Uploading and organizing regulatory and clinical documents into electronic document management systems
- Ensuring document quality, completeness, and compliance with regulatory standards before filing
- Maintaining accurate document naming conventions and classification standards
- Tracking project documentation and ensuring accessibility of files for clinical research teams
- Supporting filing activities related to Early Access Programs, external research projects, observational studies, and non‑interventional studies
- Collaborating with project teams to ensure document timelines and submission milestones are achieved
- Monitoring project progress and informing supervisors if deliverables are at risk
- Participating in internal and client meetings to support documentation processes
- Contributing to the improvement of workflows, processes, and standard operating procedures (SOPs)
- Ensuring compliance with regulatory standards including FDA, EU guidelines, and GxP requirements
- Maintaining digital archiving practices to ensure long‑term preservation of regulatory documents
This role is critical to maintaining regulatory compliance and document integrity within global clinical research and pharmaceutical development projects.
Eligibility and Qualifications
Candidates interested in this medical writing and clinical documentation role should meet the following requirements.
Required Education
Bachelor’s degree in life sciences or clinical sciences.
Relevant courses include:
Pharmacy, Biotechnology, Microbiology, Biochemistry, Life Sciences, Biomedical Sciences, Clinical Research, Pharmacology, Molecular Biology, Public Health
Candidates with experience in copyediting, scientific publishing, regulatory document review, or data integrity review may also be considered.
Experience
- Minimum 1–2 years of experience in clinical documentation management or medical writing support
- Experience working with eTMF systems or document management systems
- Familiarity with Veeva RIM or Veeva Clinical platforms
Required Skills
- Strong understanding of GxP guidelines and clinical research documentation standards
- Knowledge of electronic Trial Master File (eTMF) processes
- Excellent written and verbal communication skills
- Strong attention to detail and organizational abilities
- Ability to manage multiple assignments and meet project deadlines
- Strong proficiency in Microsoft Office tools including Word, Excel, and PowerPoint
Preferred Knowledge
- Understanding of FDA and EU regulatory requirements
- Familiarity with ICH guidelines and ISO standards
- Experience working in CRO environments or pharmaceutical research organizations
Location and Salary
Job Location: Gurgaon, Haryana, India
Work Model: Hybrid / Home‑based flexibility
Working Hours: 12 PM – 9 PM shift
Salary details for this role have not been publicly disclosed. Compensation typically varies depending on experience in clinical documentation, regulatory writing, and CRO project environments.
Application Process
Candidates interested in this medical writing and clinical documentation opportunity can apply through the official Syneos Health careers portal.
Apply here:
Applicants are encouraged to submit applications only through official company channels to avoid recruitment scams.
Frequently Asked Questions
What does a Medical Writer I (Project Specialist) do?
A Medical Writer I supports clinical documentation management, regulatory document filing, and electronic Trial Master File maintenance to ensure clinical research projects meet regulatory and quality standards.
What qualifications are required for this job?
Candidates should hold a bachelor’s degree in life sciences such as Pharmacy, Biotechnology, Microbiology, or Clinical Research.
What experience is required?
Approximately 1–2 years of experience in clinical documentation, medical writing support, or eTMF document management is preferred.
What tools should candidates be familiar with?
Candidates should ideally have experience working with Veeva Clinical, Veeva RIM, or other document management systems used in clinical trials.
Is the job remote or office based?
The role follows a hybrid work model with home‑based flexibility and collaboration with teams in Gurgaon.
Job Summary
| Company | Syneos Health |
|---|---|
| Vacancies | Medical Writer I (Project Specialist) |
| Required Education | Pharmacy, Biotechnology, Microbiology, Biochemistry, Life Sciences, Biomedical Sciences, Clinical Research, Pharmacology, Molecular Biology, Public Health |
| Experience | 1–2 years in eTMF filing, document management, or clinical documentation |
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.
