07/11 Mantras2success HR
Co-Founder at Mantras2success

Views:143 Applications:3 Rec. Actions:Recruiter Actions:1

Senior Regulatory Writer - eCTD/PSUR (3-6 yrs)

Ahmedabad Job Code: 23471


- Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols.

- Write, and 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, and 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.

Client Company Profile : Ayurveda Nutritionist |Lifestyle preacher| Lose fat not weight, Reverse Diabetes, Hypothyroid, Hypertension | Fit India campaigner

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