Job
Description
Ø Job Title: Associate (Full time employment)
Ø Skillset: e-TMF/ Document Specialist, Good Communication Skills, having Excel knowledge would be an added advantage
Ø Line of business: Medical Devices & Pharma Services
Ø Work timings: 24/ 7 rotational (night shifts will prevail)
Ø Work Location: Kolkata (candidate who is out of transport boundary will have to relocate to Kolkata vicinity as per our transport team guidelines)
Roles & 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 the DIA reference model
- Ensure the identified properties and features from clinical documents are correct
- Understanding of Common Technical Document (CTD) structure
Qualifications:
Pharmacy (B. Pharm/ M. Pharm) as well as educational stream Life Sciences- Biotechnology, Microbiology, Genetics, Zoology, Bio-Engineering, Botany, Environmental Sciences, Clinical Research Degree/ Diploma.