Medical Writer Remote Job at Syneos Health. eTMF filing, Veeva RIM and regulatory documentation pharma career opportunity.
Company Overview
Syneos Health is a globally recognized biopharmaceutical solutions organization that provides integrated services across clinical development, medical affairs, and commercialization. The company partners with pharmaceutical and biotechnology organizations to accelerate the development and delivery of innovative therapies.
With operations in more than 100 countries and a workforce of thousands of professionals, Syneos Health plays a key role in advancing clinical research and helping life-saving treatments reach patients worldwide. The company’s collaborative model integrates scientific, medical, and commercial expertise to support modern healthcare innovation.
Professionals working at Syneos Health gain exposure to global clinical trials, regulatory documentation processes, and advanced digital systems used in the pharmaceutical industry. Medical Writer Remote Job at Syneos Health
Job Location & Employment Type
- Company: Syneos Health
- Position: Medical Writer I (Project Specialist)
- Job Location: India – Remote / Gurugram (Hybrid Option)
- Employment Type: Full-Time
- Work Shift: 12 PM – 9 PM
- Industry: Clinical Research / Medical Writing / Regulatory Documentation
This role focuses on clinical documentation management and electronic Trial Master File (eTMF) filing within regulated pharmaceutical environments. Medical Writer Remote Job at Syneos Health
Open Position / Department Details
Medical Writer I (Project Specialist)
Syneos Health is seeking a Medical Writer I who will support document management and eTMF filing activities for clinical research and regulatory documentation projects.
The selected candidate will work within digital document management systems such as Veeva RIM and Veeva Clinical to ensure accurate filing, classification, and maintenance of project documentation. The role requires attention to detail, strong organizational skills, and familiarity with regulatory documentation processes used in pharmaceutical research.
This opportunity is ideal for professionals with experience in document management systems, eTMF filing, and regulatory documentation compliance. Medical Writer Remote Job at Syneos Health
Key Roles & Responsibilities
The Medical Writer I will support documentation management activities within clinical and regulatory projects.
eTMF Filing and Document Management
- Perform electronic Trial Master File (eTMF) filing activities within the Veeva system.
- Manage document uploads, downloads, classification, and storage within document management platforms.
- Ensure correct document categorization according to filing structures and metadata requirements.
Document Quality and Compliance
- Verify that documents meet required quality standards before submission and filing.
- Ensure compliance with GxP guidelines and regulatory documentation standards.
- Maintain document integrity and traceability within the electronic filing system.
Metadata and Filing Structure Management
- Apply correct naming conventions to project documents.
- Validate metadata information before storing documents within the system.
- Ensure files are placed in the correct folders according to project filing structures.
Project Documentation Tracking
- Monitor project documentation and maintain accurate records.
- Ensure project documents remain organized and easily accessible.
- Support teams in maintaining updated project documentation.
Regulatory and Study Documentation Support
- Handle documentation related to Early Access Programs, observational studies, and non-interventional research projects.
- Support document management for external research projects and regulatory submissions.
Workflow and Process Support
- Contribute to the development and improvement of workflows and Standard Operating Procedures (SOPs).
- Adapt to evolving operational processes within the organization.
Stakeholder Collaboration
- Work closely with client stakeholders and internal project teams.
- Participate in internal and client meetings to discuss documentation processes and project requirements.
- Support resolution of documentation-related queries and comments.
Timeline and Project Monitoring
- Track timelines for assigned documentation tasks.
- Inform project managers or lead medical writers if deliverables are at risk.
- Ensure project milestones are achieved within specified timelines.
Digital Archiving and Record Management
- Ensure electronic records are securely archived and preserved.
- Maintain organized document repositories that support regulatory audits and inspections.
Medical Writer Remote Job at Syneos Health
Eligibility Criteria
Education
Candidates should possess a Bachelor’s degree in Life Sciences or Clinical Sciences.
Relevant experience in document management, publishing, or data integrity review may also be considered.
Experience
- 1–2 years of experience in eTMF filing or document management systems.
- Experience working with Veeva RIM or Veeva Clinical systems is preferred.
Skills Required
Applicants should demonstrate strong technical and communication skills related to regulatory documentation.
Technical Skills
- Experience working with Veeva RIM / Veeva Clinical systems
- Knowledge of eTMF filing and document management workflows
- Familiarity with metadata management and document classification
Regulatory Knowledge
- Understanding of GxP guidelines and regulatory documentation standards
- Familiarity with FDA and EU regulatory requirements
- Knowledge of ICH guidelines and ISO standards is preferred
Software Skills
- Proficiency in Microsoft Office tools including Word, Excel, and PowerPoint
- Experience managing digital document repositories
Professional Skills
- Strong attention to detail and organizational ability
- Excellent written and verbal communication skills in English
- Ability to work independently and meet project deadlines
- Capability to manage multiple assignments simultaneously
Salary & Benefits
Compensation will be provided as per company norms and industry standards.
Employees working with Syneos Health may receive additional benefits including:
- Competitive salary packages
- Career development and training programs
- Employee recognition and reward programs
- Global career growth opportunities
- Supportive and inclusive workplace culture
Medical Writer Remote Job at Syneos Health
Selection Process
The recruitment process may include the following stages:
- Resume screening and shortlisting
- HR or recruiter interview
- Technical interview focusing on documentation and Veeva systems
- Final interview with project management or medical writing team
- Offer and onboarding
How to Apply
Interested candidates should apply through the official careers portal of Syneos Health for the Medical Writer I (Project Specialist) role.
Applicants should highlight experience related to eTMF filing, Veeva systems, document management, and regulatory compliance in their resumes. Medical Writer Remote Job at Syneos Health
Important Dates
- Application Deadline: Not specified
Candidates are encouraged to apply early as remote medical writing roles may receive a high number of applications. Medical Writer Remote Job at Syneos Health
Why Apply for This Pharma Job?
This position provides a strong entry point into medical writing and regulatory documentation within the global pharmaceutical industry. Medical Writer Remote Job at Syneos Health
Key advantages include:
- Opportunity to work on international clinical research documentation projects
- Experience with industry-standard systems such as Veeva RIM and eTMF
- Exposure to regulatory documentation processes in pharmaceutical development
- Career growth in medical writing and clinical documentation management
- Collaboration with global clinical research teams
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that publishes employment opportunities in the pharmaceutical, biotechnology, clinical research, and healthcare sectors.
We are not affiliated with Syneos Health or any company mentioned in this job post. Candidates should verify job details and apply through the official company careers portal. Medical Writer Remote Job at Syneos Health
Final Call-to-Action
Candidates interested in clinical documentation, regulatory writing, and pharmaceutical research are encouraged to apply and build a career in global medical writing. Medical Writer Remote Job at Syneos Health
