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Celegence Systems
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CMC (Authoring)-Writer(Bangalore)

CMC (Authoring)-Writer(Bangalore)

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Celegence Systems

6 - 7 years

9 - 15 Lacs

bengaluru

Posted:1 week ago| Platform:

Apply

Skills Required

cmc authoring cmc writing

Work Mode

Hybrid

Job Type

Full Time

Job Description

Designation : CMC writer(Author)

Job location: Jayanagar(Bangalore)

Work mode:

Role & responsibilities

6 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 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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CMC (Authoring)-Writer(Bangalore)