Description

Role & responsibilities 1. Drafting & Preparation of Phase I, II, III & IV protocol, synopsis, PIS for various therapeutic areas such as respiratory, diabetes mellitus, pain, ophthalmic, antimicrobials, cardiovascular and other specialties for India and global submissions. 2. Writing CSR, IBs, SmPCs, PIs, PILs. 3. Project assignment and timeline to CRAs -Operation team, discussion with KOL and finalization of scientific study Documents as per requirements 4. Literature search, systemic review of data and its analysis so as to be up to date with latest breakthrough in the therapeutic area. 5. Working closely with physicians and senior scientists for study designs and protocol development to influence the clinical pharmacology strategy in support of drug development. 6. Preparing presentations, posters, research articles, abstract, and manuscripts for publication purpose. 7. Activities as and when required.

Role and Responsibilities

• Role & responsibilities 1. Drafting & Preparation of Phase I, II, III & IV protocol, synopsis, PIS for various therapeutic areas such as respiratory, diabetes mellitus, pain, ophthalmic, antimicrobials, cardiovascular and other specialties for India and global submissions. 2. Writing CSR, IBs, SmPCs, PIs, PILs. 3. Project assignment and timeline to CRAs -Operation team, discussion with KOL and finalization of scientific study Documents as per requirements 4. Literature search, systemic review of data and its analysis so as to be up to date with latest breakthrough in the therapeutic area. 5. Working closely with physicians and senior scientists for study designs and protocol development to influence the clinical pharmacology strategy in support of drug development. 6. Preparing presentations, posters, research articles, abstract, and manuscripts for publication purpose. 7. Activities as and when required.