Company: Infoclin Consultancy
Post: Senior Executive Regulatory Affairs in Clinical Research.
Qualification: M.Pharm, M.Sc, PharmD
Experience: Freshers - 1 year ( only relevant experience will be counted)
Job Location: Kolkata
Job Description:
- Updating self with New Drug CT rule_2019.
- Reviewing of SOP of clinical trial sites.
- Quality control tasks on submission components.
- Proficiency with ICH-GCP guidelines.
- Under supervision, adherence to project milestones and timelines.
- Contributing to departmental initiatives.
- Working with the team leader to establish individual goals to meet project timelines.
- Providing timely communication on status and /or issues pertaining to Clinical research.
- Knowledge of submission dossier to CDSCO.
- Paying attention to details for accomplishing publishing tasks.
- Having industry knowledge; understanding of the industry, and FDA requirements.
- With guidance, creating and maintaining project documentation including meeting agendas, and meetings.
- Minutes of meetings, issues and status reports internally and externally.
- Performing relevant duties for projects as assigned.
- SAE reporting.
Salary: No bar for the right candidate
The job incumbent must be flexible to travel if needed.
Notice period: Immediate to 15 days Maximum
Interested candidates kindly post across updated CV at hr@infoclinconsultancy.com
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