Sr. Regulatory Writer
Job Description:
Role:
• Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols.
• Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports.
• Drafting and revising pre-clinical summaries.
• Quality control of documents for content, uniformity, adherence to ICH/FDA/EMEA or other appropriate regulatory guidelines. Ensure compliance with company or client SOPs and style guidelines.
• Write and maintain Standard Operating Procedures and Style Manuals for internal process and external process.
Requirement:
A PhD/Masters/Bachelor' s degree or expertise in one or more specialized subject areas In healthcare. medicine and research writing (AMWA/ EMWA certification will be a great value add).
Minimum 3 Years of experience as a Medical RWE Writer in HealthCare / Medical / HealthTech can apply for this position.
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