Technical Writer

Organization
Kashiv Pharma
Job Location
Bridgewater, NJ
Job Description

Overview: 
Kashiv Pharma, LLC. is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture. 
Responsibilities: 
Key responsibilities of the position include, but are not limited to – 

Organize material and complete writing assignments according to set standards regarding order, clarity, conciseness, style and terminology. 
Build relationships with subject matter experts in cross functional groups including walking down a process to insure completeness and verify correctness. 
Observe production, development, and experimental activities to determine operating procedure and detail. 
Experience with computer based change management software, including ISI Writer. 
Review published materials and recommend revisions or changes to scope, format, content, and methods of reproduction or binding. 
Prepare and/or review submission documents for ANDA, IND, NDA filings. 
Prepare and /or review analytical related reports including method validation reports, stability reports, etc. 
Prepare and /or review analytical test methods and specifications for drug products, drug substances, exception, package components 
Prepare SOPs and perform SOP training.

Requirements: 

Qualifications: 
Bachelor or Master degree in Chemistry, Pharmaceutical or related disciplines 
1 - 3 years of experience in the pharmaceutical, medical, or other FDA regulated environment. 
Responsible to write, review and revise documents with an understanding of how to structure reports. 
Must be quality focused and deadline oriented. 
Excellent communication skills, (written and verbal) 
Computer literate with ISI Writer 
Ability to work well in a fast-paced professional office environment

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