CSR Expert
- Golden Opportunities
- 5 - 10 Years
- Chennai
- 4 years ago
- Email to a friend
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Job Description
Job Role: CSR Regulatory WriterPreferred Educational Qualification for the role:
Doctors (MBBS BAMS BHMS BDS MS/MD PhD) and/or graduate/post graduate in life science pharmacy or nursing.
Preferred experience for the role:
Experience: 8 plus years in medical writing with 5 plus year in Regulatory CSR writing Experience in ICH E3 Compliant CSR writing for innovator molecule.
Responsibilities :
- To perform safety periodic writing including assessment analysis and authoring of Clinical Study Report (CSR) assigned by the supervisor.
- To effectively operate in an environment that requires negotiation persuasion collaboration and analytical judgment.
- To have thorough knowledge to the tools and databases required during the process
- To understand and interpret data/information and its practical application.
- Planning for all assigned reports as per the client training including conducting Kick off Meetings.
- To request and ensure the receipt of contribution from the various stake holders necessary for authoring of the assigned reports.
- To ensure the completion of authoring QC review of the assigned reports within the specified timelines.
- To perform peer review of the assigned CSR
- To provide daily progress update regarding the status of the assigned reports to the supervisors.
- To track and ensure that the progress of reports is as per the client defined timelines.
- To ensure the timely completion of all activities and trackers maintained for the project.
- To ensure the completion of all assigned project related activities assigned by the supervisors.
- To ensure compliance to SOPs and other process related documentation.
- To impart trainings mentor and groom the new associates.
- To provide innovative suggestions and ideas for process optimization.
- To ensure that all CSR related trainings are completed within allotted period.
- To achieve the supporting documents in respective repositories for reference.
LOCATION : Bangalore/ Mumbai/ Pune
Employement Category:
Employement Type: Full timeIndustry: Bio Technology & Life SciencesFunctional Area: PharmaceuticalRole Category: DocumentationRole/Responsibilies: CSR ExpertContact Details:
Company: Golden OpportunitiesLocation(s): Chennai+ View Contact
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