Sr Medical Writer (Redaction) -
Updated: March 26, 2025
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002334
Description:
Sr Medical Writer (Redaction)
Syneos Health® is a fully integrated biopharmaceutical solutions organization, accelerating customer success by translating unique clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model centers around the customer and patient, continually simplifying and streamlining work to make Syneos Health both easier to work with and work for.
Why Syneos Health:
Total Self Culture: Be yourself authentically in a globally united environment that values diversity and inclusion.
Career Development: Opportunities for progression, supportive line management, and peer recognition.
Purpose-Driven Work: Passion to change lives through accelerating the delivery of therapies.
Job Summary:
Clinical Trial Disclosure plays a critical role in executing projects for Syneos global clients, processing complex scientific, medical, and technical information as part of high-performing teams.
Job Responsibilities:
1. Authoring and Quality Assurance of Project Activities:
Execute project-specific activities with high quality within defined timelines following standard processes and SOPs.
Marking/QC/Review and/or editing of documents, including:
Clinical study documents for regulatory submission (clinical study reports, patient narratives, clinical summaries).
Protocol and results summaries for clinical trial disclosure commitments.
Systematically perform quality control checks of documents prepared by colleagues using project or SOP-generated checklists.
Conduct detailed analyses on planned and ad hoc processes and their outputs.
Ensure adherence to client processes.
2. Additional Activities:
Completion of internal and client-specific training.
Assist in mentoring and training team members as needed based on project requirements.
Qualifications:
What We’re Looking For:
4-8 years of experience in medical writing with expertise in redactions/anonymization of clinical documents aligned with regulations such as:
EMA policy 0070
Health Canada PRCI
EUCTR regulation
Final rule-NIH
Knowledge of preparing disclosure documents (e.g., Protocol Registration Form, Result Registration Form) for clinicaltrials.gov and other clinical registries.
Strong comprehension of protocols and clinical study reports from a disclosure perspective.
Good understanding of Clinical Trial Disclosure fundamentals.
Qualification Requirements:
Educational Background: Minimum of a scientific graduate degree in life sciences.
Regulatory Knowledge: Good understanding of regulatory requirements and clinical development processes, including ICH-GCP guidelines.
Communication Skills: Clear written and verbal communication abilities.
Technical Proficiency: Basic knowledge of MS Word, PowerPoint, and Excel.
Core Competencies:
Analytical capabilities with scientific and clinical data.
Ownership and accountability of assigned work.
Commitment to high-quality outputs with keen attention to detail.
Enthusiasm and proactivity.
Effective teamwork and ability to build rapport with project-specific clients.
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
Over 200 Studies across 73,000 Sites and 675,000+ Trial patients
Join us to challenge the status quo and make a lasting impact in a competitive, ever-changing environment.
Additional Information:
Tasks, duties, and responsibilities as listed are not exhaustive and may be modified at the Company’s discretion.
Equivalent experience, skills, and/or education may be considered to meet qualifications.
Syneos Health is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when appropriate to assist employees or applicants in performing essential job functions.
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