Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 50 /hr

★★★★★

☆☆☆☆☆

Hire Dr Febin F.

India

USD 50 /hr

Scientific Writer with 3+ year experience

Profile Summary

• Scientific Writer with experience in end-to-end handling of Clinical Evaluation Reports (CERs, both MDD and MDR compliance). • Authored scientific content for a variety of deliverables which include abstracts, scientific bulletins, slide deck, evidence summaries, literature analysis, clinical evaluation reports, clinical evaluation plans, post-market surveillance reports, post market surveillance plans, periodic safety update reports and clinical risk-benefit analysis documents • Authored regulatory documents such as Clinical Study Report (CSR), Module 2.4, 2.6.4, 2.6.5, 2.6.6, 2.6.7 and performed FDA eCTD formatting. • Developed literature search protocols and literature search strategies, literature review protocols, literature screening and summarization of articles • Critically analyzed complaints and adverse events associated with medical devices and develop medical rationale documents • Performed data fact check and quality check of the documents authored

Subject Matter Expertise

• ★ Regulatory Writing
• ★ Clinical Evaluation Reports (CER)
• ★ Medical Writing
• ☆ European Medical Device Regulation (MDR)
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Study Reports

Services

• Writing

Writing Technical Writing

Work Experience

Associate Scientific Writer

Indegene Private Limited

February 2019 - November 2021

Education

PharmD (Pharmacy practice)

Erode College of Pharmacy and Research

September 2012 - Present

Doctor of Pharmacy

The Erode College of Pharmacy and Research Institute

October 2012 - December 2018

Certifications

• Certification details not provided.