Senior Associate - Medical Writing | Q892

Senior Associate - Medical Writing | Q892

06 Jun
Silmed Scientific Pvt Ltd
Bangalore Urban

06 Jun

Silmed Scientific Pvt Ltd

Bangalore Urban

Job Profile

We are hiring an experienced medical writer with experience in CTD medical writing and experience in clinical development of medicines.

Writing high quality CTD modules nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) as per requirements in EU submission

Response to clinical deficiencies

Assist with drug development strategy

SmPC, Patient information leaflet

Clinical study reports, Study design and synopsis

Assist in clinical development strategy Review of Study reports published papers

Literature search and regulatory evaluation

Rx to OTC evaluation


Ideal candidate should have

Must have 4-7 years previous experience authoring global clinical submissions including, but not limited to, clinical study reports (CSRs), study protocols, informed consent forms (ICFs), protocol amendments, ICF amendments, eCTD modules specifically 2.4 - 2.7), DSURS, PBRERs and signal evaluation reports. Working knowledge of industry guidelines and standards (FDA, EMA, ICH, PMDA)

Scientific accuracy

Attention to details

Understanding of Generic, Hybrid and New drug applications

Experience in Clinical study design and protocol

Excellent communication skills and time management

Experience in Clinical and non-clinical overviews is a must

The original job offer can be found in Kit Job:

Reply to this offer

Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.

Subscribe to this job alert:
Enter Your E-mail address to receive the latest job offers for: senior associate - medical writing | q892
Publish a new Free Offer
Need to publish an offer? With more than 1 million unique users per month, you will find the ideal candidate for your company instantly, what are you waiting for!
Publish Now

Subscribe to this job alert