Associate Manager - Regulatory Writing

Job description

We are seeking a candidate with expertise in core authoring of various clinical document types that support regulatory filings. Preference will be given to those with experience in Module 2.4, 2.5, 2.6, 2.7, and 5.2, as well as clinical study reports (CSRs), protocols, amendments, informed consent forms (ICFs) and amendments, and Investigator Brochures (IBs). \\*\\*Location:\\*\\* Bangalore, Hyderabad, Pune, Mumbai, Delhi \\*\\*Work Model:\\*\\* Hybrid \\*\\*Education:\\*\\* MBBS/PhD/MDS/BDS/MPharm/PharmD \\*\\*Experience:\\*\\* 10 to 12 years in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5) \\*\\*Team Handling Experience:\\*\\* Required