CMC (Authoring)-Writer(Bangalore) Celegence Systems

3.0 - 8.0 years

5 - 15 Lacs

Bengaluru

Hybrid

Designation : CMC writer(Author) Job location: Jayanagar(Bangalore) Work mode: Hybrid(3 days a week) Role & responsibilities 3-7 years of prior CMC Authoring/Writing experience preferred. Hands on in Authoring of the documents . Expertise in Dosage forms and OTC products. Expertise in Formulations. Interested in expanding his/her knowledge of pharmaceutical manufacturing and testing as it pertains to eCTD Modules 2 and 3 writing and support labelling activities Experience in the pharmaceutical or CRO industry preferred Experience in pharmaceutical manufacturing or testing activities is mandatory. You need to be expert in Gap Analysis of the documents Work on the preparation of the documents Independently handle all the collection of the documents Management of the regulatory documents Types of Products and Geographies You will be working on different types of dosage forms, solid orals and some sort of injectables. It is both for New Product development and lifecycle management. You will get a chance to work on various global countries like EU, Europe, LATAM and limited extend to Asia pacific/US FDA. Technical Skills Good Chemistry Manufacturing & Control (CMC)writing skills and understanding of ICH requirements Proficiency with MS Office applications and style guides for writing various document types Ability to convert technical information into regulatory-compliant documentation Soft Skills Excellent English written and verbal communication skills Good organizational, interpersonal and communication skills **We would require someone who can join in 30 days OR an immediate joiner.

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