PharmaLex - Medical Writer

Minimum - 2 years in Regulatory writing

Qualification: M.Pharm/PhD (Pharmacology)/MBBS

- Thorough understanding of ICH-E6, ICH-M4S, ICH-M4E guidelines

- Thorough understanding of legal basis to get marketing authorization in Europe and the US

- Excellent skillset to interpret the complex data to write CSR

- Basic understanding of statistics

- Experience in writing Mod 2.4, 2.5, 2.6, and 2.7 of CTD

- Experience in developing CSR and protocols

- Have an understanding of various functions of MS-office

- Is able to perform a systematic literature search

- Have some experience in writing manuscript/publications/posters

- Candidate with experience in writing a systematic review and meta-analysis will be preferred