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If you’re looking to advance your career in clinical trial disclosure, clinical trial transparency, and regulatory medical writing, this new opening for Medical Writer II at Syneos Health is an excellent opportunity. Professionals with hands-on experience in CTD, CTT, ClinicalTrials.gov, EudraCT, CTIS, and disclosure platforms like PharmaCM/Disclose are strongly encouraged to apply.
This remote medical writing role is ideal for candidates with 1–3 years’ experience who are passionate about improving global clinical research transparency.
Key Responsibilities
- Prepare and submit Clinical Trial Disclosure (CTD) and Clinical Trial Transparency (CTT) documents.
- Manage protocol registrations across global clinical trial registries.
- Post results to US FDA, ClinicalTrials.gov, EudraCT, CTIS, and national registries.
- Ensure high-quality documentation aligned with regulatory standards.
- Collaborate with internal stakeholders to support disclosure and transparency initiatives.
Required Qualifications
- 1–3 years’ experience in CTD, CTT, and regulatory medical writing.
- Strong knowledge of clinical research, clinical trials, and global registries (CT.gov, CTIS, EudraCT).
- Mandatory experience with databases like PharmaCM, Disclose, or similar.
- Excellent written and verbal communication skills.
- Strong stakeholder coordination skills and attention to detail.
Preferred Skills
- Deep understanding of protocol registration processes.
- Prior involvement in transparency, data sharing, or regulatory disclosure teams.
- Ability to handle multiple studies and timelines independently.
Benefits
- Remote working flexibility.
- Exposure to global regulatory systems.
- Opportunity to grow within medical writing and disclosure operations.
- Work with a globally renowned CRO improving clinical trial transparency.
How to Apply
Send your updated CV to:
📩 vishal.milindkulkarni@syneoshealth.com
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