Hello connections,
Recruise India Consulting Pvt Ltd
hashtag Hiring # Lead/Associate Manager – Scientific Writing.
đź“Ťhashtag Location hashtag Bengaluru hashtag Hyderabad hashtag Mumbai hashtag DelhiNCR hashtag Pune
Experience: 5-10 Years
âś… Mandatory skill sets:Â Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.3, 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs,) protocols, Informed Consent Forms, amendments, and Investigator Brochures (IBs)
RESPONSIBILITIES:
•   Without guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development
•   Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of authoring process
•   Develop and maintain project plans
•   Work as an active member of cross-functional teams representing Medical Writing
•   Coordinate and deliver document kick-off meetings with writers and cross-functional representatives
âś… Education qualification:Â Â MBBS/PhD/MDS/BDS/MPharm/PharmD
Drop your CV ✉️ shalini@recruiseindia.com
To apply for this job please visit www.linkedin.com.