Principal Medical Writer (CTT)
Updated: Yesterday
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002335
Description
Principal Medical Writer (CTT)
Come discover what our 25,000+ employees already know—‘Work Here Matters Everywhere.’ We’re a growing and evolving biopharmaceutical industry leader, offering endless opportunities to work with experts worldwide and build the career you’ve dreamed of.
Why Syneos Health
#SyneosHealthLife: We are committed to our Total Self culture—where everyone can authentically be themselves. Our diverse environment allows everyone to feel valued.
Comprehensive Benefits Program: Encompasses physical, mental, and financial health to ensure your well-being.
Diversity and Inclusion: Bringing together diverse thoughts, backgrounds, cultures, and perspectives to create an environment where everyone belongs.
Job Summary
Clinical Trial Disclosure plays a critically important role in executing projects for Syneos’ global clients. The Principal Medical Writer works on high-performing teams, managing complex scientific, medical, and technical information.
Job Responsibilities:
Authoring and Quality Assurance of Project Activities:
Executes project-specific activities with high quality and within defined timelines following standard processes and operating procedures.
Marking/QC/Review and/or editing of relevant documents, including:
Clinical study documents, clinical study reports, patient narratives, and clinical summaries for regulatory submissions (EMA policy 0070, Health Canada PRCI, EUCTR regulation, NIH Final Rule, national registries such as DIMDI).
Protocol and results summaries for clinical trial disclosure commitments.
Systematically performs quality control checks of documents prepared by colleagues using project-specific checklists or SOPs.
Conducts detailed analyses on a planned and ad hoc basis to evaluate processes and outputs.
Ensures compliance with client processes.
Additional Activities:
Completes internal and client-specific training.
Assists in mentoring and training team members based on project requirements.
Qualifications:
Experience: Minimum 8 years in medical writing, specifically involving CTT, redactions, and anonymization of clinical documents for regulatory submissions.
Expertise:
In-depth knowledge of EMA policy 0070, Health Canada PRCI, EUCTR regulation, NIH Final Rule, and other applicable regulations.
Experience in preparing disclosure documents (Protocol Registration Form, Result Registration Form) for clinicaltrials.gov and other clinical registries.
Strong comprehension of clinical trial disclosure fundamentals, protocols, and clinical study reports from a disclosure perspective.
Educational Requirements:
Minimum of a scientific graduate degree in life sciences.
Technical Skills:
Good understanding of regulatory requirements or guidance pertinent to the service line.
Knowledge of clinical development processes, principles of clinical study operations, and ICH-GCP guidelines.
Proficiency in MS Word, PowerPoint, and Excel.
Core Competencies:
Analytical capabilities with scientific and clinical data.
Ability to build rapport and maintain relationships with project-specific client colleagues.
Strong attention to detail and commitment to delivering high-quality outputs.
Effective team working, ownership, and proactivity.
Get to Know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and responsibilities at its discretion. Equivalent experience, skills, and/or education may be considered. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations where appropriate.
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