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
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.
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
Role Category:Non Voice
Employment Type:Full Time, Permanent
UG:B.Pharma in Any Specialization,B.Sc in Hospitality and Hotel Management, Bio-Chemistry, Microbiology, Botany, Chemistry, Zoology, Environmental Science
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