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.