Sr. Regulatory Writer

Sr. Regulatory Writer

2 Nos.
67779
Full Time
3.0 Year(s) To 4.0 Year(s)
6.50 LPA TO 8.00 LPA
Pharma / Biotech / Healthcare / Medical / R&D
Medical/Healthcare/Hospital
B.Pharma - Pharmacy; M.Pharma - Pharmacy; M.PHIL - Pharmacy; MD/MS/DM - Pharmacy; Ph.D/Doctorate - Pharmacy
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.

Company Profile

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