Work as Principal Medical Writer – Clinical Trial Transparency (CTT) at Syneos Health-Apply before 30th June 2025

About Syneos Health

At Syneos Health, we are the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. With a product development mindset, we deliver tailored insights and operational excellence to speed therapies to patients across the globe.

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Position: Principal Medical Writer – Clinical Trial Transparency (CTT)

Job ID: 25002335
Location: Gurugram
Industry: Pharma / Healthcare / Clinical Research
Application Deadline: 30th June 2025

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Key Responsibilities

1. Authoring & Quality Assurance of CTT Documents

• Author, QC, and review regulatory clinical documents (e.g., clinical study reports, clinical summaries, patient narratives) to meet global disclosure regulations including EMA Policy 0070, Health Canada PRCI, EUCTR regulation, and NIH Final Rule.

• Work with CTT platforms (e.g., Disclose, Prime, PRS, EudraCT) for preparation of protocol and results summaries.

• Ensure compliance with both internal and client-specific SOPs, with high-quality deliverables within established timelines.

• Conduct thorough quality control of clinical documents based on project-specific checklists.

2. Mentorship and Training

• Contribute to internal knowledge-building by mentoring junior team members as needed.

• Complete required internal and client-specific training modules to ensure up-to-date process knowledge.

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Candidate Profile

We are looking for an experienced and detail-oriented professional who can lead medical writing projects focused on clinical trial disclosure and redaction.

Qualifications:

• Graduate degree in Life Sciences (essential).

• Minimum of 8 years’ experience in medical writing, with a focus on CTT, redactions, and anonymization.

• Strong working knowledge of global disclosure regulations and registry requirements (clinicaltrials.gov, EUCTR, Health Canada, NIH, etc.).

Skills & Competencies:

• Deep understanding of clinical study protocols, clinical study reports, and the disclosure perspective.

• Familiarity with ICH-GCP guidelines and clinical development operations.

• Proficient in Microsoft Office (Word, PowerPoint, Excel).

• Strong analytical skills with an ability to interpret scientific and clinical data.

• Excellent communication skills—both verbal and written.

• Proven ability to manage client communications effectively and professionally.

• Demonstrated ownership, attention to detail, and a commitment to quality.

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Why Join Syneos Health?

• Be part of a global team advancing clinical science and patient outcomes.

• Engage in challenging projects that have real-world impact.

• Access opportunities for growth, mentorship, and innovation in a supportive environment.

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Ready to lead in clinical transparency and make a difference?
Apply today and bring your expertise to Syneos Health.

For more information, visit: www.syneoshealth.com