CSR Expert Job For 5-10 Year Exp In Golden Opportunities Private Limited Bengaluru / Bangalore, Mumbai – 3763147

Job Role: CSR Regulatory Writer
Preferred 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

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