Associate/ Sr Associate (Freshers/ Experienced both Can apply)

From 0 to 5 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

Roles and Responsibilities

Job Title: Associate/ Sr Associate (Full time employment)


* Skillset: e-TMF/ Document Specialist, Good Communication Skills, having Excel knowledge would be an added advantage

*Line of business: Medical Devices & Pharma Services

*Work timings: 24/ 7 rotational (night shifts will prevail)

*Work Location: Kolkata, Salt Lake Sec-5


Responsibilities:


Understanding of clinical documents(Trial Master File (TMF), Safety , Submission and R&D related documents)and publishing

Ensure the clinical document are categorized in accordance with theDIA reference model

Ensure the identified properties and features from clinical documents are correct

Understanding ofCommon Technical Document (CTD) structure


Below Work Experience is an advantage:


Clinical document management system and publishing

Clinical research monitoring, pharmaceutical, CRO or healthcare industry

Knowledge ofICH GCP, 21 CFR part 11 regulations

Working knowledge of clinical essential documents, including trial master file and clinical submission documents

Experience with a Documentum basedD2LS system is a plus


*Candidate should be comfortable with work from home and office both the scenarios.


Freshers keen on above opportunity having below educational background can also apply.


EDUCATIONAL BACKGROUND:

Pharmacy (B. Pharm/ M. Pharm)as well aseducational stream Life Sciences- Biotechnology, Microbiology, Genetics, Zoology, Bio-Engineering, Botany, Environmental Sciences, Clinical Research Degree/ Diploma.




Role:Technical Support - Non Voice

Salary: Not Disclosed by Recruiter

Industry:BPO / Call Centre

Functional Area:Customer Success, Service & Operations

Role Category:Non Voice

Employment Type:Full Time, Permanent

Education

UG:B.Pharma in Any Specialization,B.Sc in Hospitality and Hotel Management, Bio-Chemistry, Microbiology, Botany, Chemistry, Zoology, Environmental Science

Company Profile

Yellow Box HR Services Pvt. Ltd.

Executive Search Firm
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Contact Company:Yellow Box HR Services Pvt. Ltd.

Website:http://jobs.ybconsultants.com