Regulatory Medical Writer
Regulatory Medical Writer
Syneos Health
Job description
Thinking about a career in clinical medical writing? Syneos Health in Gurgaon is looking for a Regulatory Medical Writer to prepare clinical trial reports, patient narratives and regulatory paperwork.
Company Description
Syneos Health is a fully integrated life sciences services organization supporting customers across drug development and commercialization. Its Clinical Solutions teams work with innovators to address clinical development needs, combining scientific, operational, and commercial expertise to help advance therapies for patients worldwide through collaborative, high-quality research and service delivery globally.
Job Summary
Regulatory Medical Writer offers moderate support supervision to clinical trial and regulatory project teams in assembling, producing, revising and coordinating papers. This position will involve Clinical Study Report (CSR) narratives and may also involve protocols, modifications, study reports, patient narratives and investigator brochures. Other responsibilities include assessing statistical output, liaising with functional teams, complying with ICH-E3 guidelines, and working to project timetables and budgets.
Key Responsibilities
Develop, prepare and edit medical writing deliverables including Clinical trial Reports (CSRs), patient narratives, clinical trial protocols, protocol revisions and Investigator Brochures.
Prepare and write clinical research report narratives with scientific accuracy, consistency, clarity and in compliance with appropriate writing standards.
Review Statistical Analysis Plans (SAPs) and Table, Figure and Listing (TFL) criteria for content, grammar, formatting and consistency relevant to the document. Comments on statistical outputs required
Collaborate with Data Management, Biostatistics, Regulatory Affairs and Medical Affairs to obtain information and complete medical writing deliverables.
Ensure compliance to ICH-E3, company SOPs, client requirements and allowed templates.
Search the clinical literature online as necessary. Finish allocated projects according to schedule and budget parameters.
Educational Qualification
Bachelor's degree in Life Sciences from a recognised university.
At least one year of experience in medical writing and narrative writing.
Solid background in developing and producing CSR stories.
Strong knowledge of FDA & ICH regulations and guidelines preferred.
Skills Required
Ability to draft, modify and gather, patient histories, protocols and other medical writing outputs.
Strong knowledge of English grammar and proofreading skills; familiarity with the AMA Style Guide.
Knowledge of FDA, ICH regulations, ICH-E3 guidelines, firm SOP and clinical research documentation requirements.
Knowledge of principles of clinical research and capacity to assess and present clinical data and complex scientific information.
Excellent presenting, interpersonal and team work skills with fluency in Microsoft Word, Excel, PowerPoint, email and internet applications.
Salary Structure
The average salary of a Regulatory Medical Writer at Syneos in Gurgaon is ₹5-6 Lakhs per year.
Career Development
This role as a Regulatory Medical Writer gives opportunity to learn competence in producing clinical study reports, patient narratives, regulatory documents and clinical research. Experience with ICH guidelines and cross-functional teams can help you advance to Senior Medical Writer and Medical Affairs positions.
How to Apply
Open our job portal. Search for Regulatory Medical Writer listing.
Review the full job information and check the eligibility conditions.
Fill out the application form.
Upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
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Market insights & trends
Salary Insights
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Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.