Medical Writer II Remote Job at Syneos Health Clinical Trial Transparency for remote India role with disclosure, registries, and regulatory writing experience.
About the Company
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health transforms complex scientific insights into meaningful healthcare outcomes. Medical Writer II Remote Job at Syneos Health
With operations across more than 110 countries and a workforce of over 29,000 professionals, Syneos Health has supported the majority of novel FDA- and EMA-approved therapies in recent years. The organization is driven by innovation, agility, and a strong people-first culture where collaboration and inclusion are core values. Medical Writer II Remote Job at Syneos Health
Job Details
- Job Title: Medical Writer II – Clinical Trial Transparency
- Company: Syneos Health
- Job Location: India (Remote – Exception Based)
- Employment Type: Full Time
- Remote Work: Yes
- Job Requisition ID: 25101809
Job Description
The Medical Writer II – Clinical Trial Transparency role is responsible for supporting global clinical disclosure and transparency activities. The position focuses on preparing, reviewing, and maintaining accurate clinical trial disclosure records in compliance with international regulatory requirements. Medical Writer II Remote Job at Syneos Health
This role requires hands-on experience with clinical trial registries and disclosure systems, along with strong medical writing and regulatory knowledge. The Medical Writer II works independently with minimal supervision while collaborating closely with cross-functional teams.
Medical Writer II Remote Job at Syneos Health
Key Responsibilities
- Perform clinical trial disclosure activities with 1–3 years of relevant experience
- Register and maintain clinical trials in global registries such as ClinicalTrials.gov, CTIS, and EudraCT
- Prepare, review, and submit disclosure records using systems such as Pharma CM and Disclose
- Support protocol registration and clinical trial transparency timelines
- Compile, write, and edit clinical and regulatory documents with minimal supervision
- Develop and support documents including protocols, protocol amendments, clinical study reports, patient narratives, annual reports, and investigator brochures
- Review statistical analysis plans and tables, figures, and listings for accuracy and consistency
- Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams
- Serve as a peer reviewer and address internal review comments effectively
- Ensure compliance with ICH-E3 guidelines, company SOPs, client standards, and approved templates
- Conduct online clinical literature searches when required
- Mentor junior medical writers as needed
- Manage assigned projects within budget and timelines
- Maintain ongoing professional development related to regulatory guidance and medical writing standards
Medical Writer II Remote Job at Syneos Health
Skills / Qualifications
Required Qualifications
- Bachelor’s degree in a relevant discipline; graduate degree preferred
- 1–3 years of experience in clinical trial disclosure and transparency
- Mandatory experience with clinical trial registries and disclosure systems
- Strong understanding of FDA, ICH, and global regulatory guidelines
- Proven experience writing clinical and regulatory documents
- Excellent command of English grammar and AMA Manual of Style
Medical Writer II Remote Job at Syneos Health
Desired Skills
- Client-facing communication experience
- Strong understanding of clinical research and drug development processes
- Proficiency in MS Office tools
- Strong proofreading, presentation, and collaboration skills
- Ability to interpret and present complex clinical data clearly
Medical Writer II Remote Job at Syneos Health
Benefits / Perks
- Fully remote work opportunity within India
- Career development and progression programs
- Technical and therapeutic area training
- Supportive and engaged line management
- Peer recognition and total rewards programs
- Inclusive “Total Self” culture promoting authenticity and well-being
- Exposure to global clinical development and disclosure projects
Medical Writer II Remote Job at Syneos Health
Why You Should Join
- Work with a global leader in biopharmaceutical solutions
- Contribute to clinical trial transparency and ethical research practices
- Be part of a high-impact organization supporting most novel drug approvals
- Collaborate with global experts across clinical and regulatory functions
- Grow your career in a flexible, people-focused, and innovation-driven environment
How to Apply
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
FAQs
Q1. Is this a fully remote role?
Yes, this position is remote within India, with minimal travel requirements.
Q2. Is disclosure experience mandatory?
Yes, hands-on experience in clinical trial disclosure and registries is mandatory.
Q3. What experience level is required?
Candidates with 1–3 years of disclosure experience are eligible.
Q4. What document types will I work on?
Protocols, CSRs, patient narratives, investigator brochures, annual reports, and disclosure records.
Q5. Does Syneos Health provide training?
Yes, ongoing technical, therapeutic, and professional development training is provided.
