Scientist Job Opening For Pharma Candidates @ Jubilant Life Science Ltd
Applications are invited for Scientist- medical post vacancy at Jubilant Life science ltd. Pharma candidates can apply for this job post. Below are the details:
Job Title: Scientist- Medical
Employment Type: Permanent Job, Full Time
Experience: 2 to 7 years
Work Location: Delhi NCR
Qualification: B.Pharma / M Pharma
Job Description:
1. Literature review, collation of published pharmacokinetic (PK) data and development of bio strategy notes/document for pipeline projects
2. To oversee development, review, and finalization of the pilot and pivotal BE protocols and support regulatory team (DRA) for timely application of local regulatory permissions (BE NOCs/T-BE-licences)
3. Planning and execution of BE studies
4. Coordination with Plant and R&D teams for timely delivery of the investigational products (IPs)
5. Monitoring of pilot and pivotal BE studies sponsored by Jubilant Generics Limited
6. Ensuring timely receipt of BE reports, reviewing the same prior to submission to the regulatory team (DRA)
7. Computation of pharmacokinetic and statistical analysis using WinNonlin software
8. Reviewing the BE data for planning of further studies. This includes analysis of PK data so as to make appropriate recommendations to the formulation development team
9. Identification of discriminatory/bio-relevant dissolution media, whenever possible based on the availability of pertinent data
10. Development of appropriate in vitro in vivo relationship/correlation (IVIVR/IVIVC) using a variety of methodologies whenever this is required and is considered feasible
11. Provide support in preparation of responses to BE deficiencies received from various regulatory agencies for filed dossiers
3. Planning and execution of BE studies
4. Coordination with Plant and R&D teams for timely delivery of the investigational products (IPs)
5. Monitoring of pilot and pivotal BE studies sponsored by Jubilant Generics Limited
6. Ensuring timely receipt of BE reports, reviewing the same prior to submission to the regulatory team (DRA)
7. Computation of pharmacokinetic and statistical analysis using WinNonlin software
8. Reviewing the BE data for planning of further studies. This includes analysis of PK data so as to make appropriate recommendations to the formulation development team
9. Identification of discriminatory/bio-relevant dissolution media, whenever possible based on the availability of pertinent data
10. Development of appropriate in vitro in vivo relationship/correlation (IVIVR/IVIVC) using a variety of methodologies whenever this is required and is considered feasible
11. Provide support in preparation of responses to BE deficiencies received from various regulatory agencies for filed dossiers
