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PLS Writing @ Golden Opportunities

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 PLS Writing

Job Description

job_description :

Candidate Specification:
Qualification: Bachelor/ Master Degree in Life Science Pharmacy or Medical Sciences (MBBS BHMS BAMS etc.)
Location: Olympus Thane / Bangalore
Preferred Experience: Minimum 6 year of experience in Regulatory Medical Writing
Added advantage: Good understanding of clinical trials; experience in interaction with client Point of Contact; good IELTS/TOEFL scores.
Job Description:
  • Prepare review and quality check of plain language summary (PLS) clinical document for regulatory submission across all the therapeutic areas.
  • Prepare the PLS by capturing correct details from the source documents including but not limited to the Clinical report Statistical Plan table/figure/listing.
  • Initiate start up meetings with the study teams related to the creation and development of the PLS if required.
  • To work in coordination with the internal and client team members and the study team for the development of PLSs.
  • Key activities include drafting ensuring client review addressing internal and client review comments; client interactions appropriate follow-up with all stakeholders to ensure timely and quality submission.
  • Timely escalation of identified unresolved issues to supervisor
  • Mentoring other writers
  • Other support activities
Location : PAN INDIA

Employement Category:

Employement Type: Full time
Industry: Pharmaceutical
Functional Area: Pharmaceutical
Role Category: Clinical Research Associate
Role/Responsibilies: PLS Writing

Contact Details:

Company: Golden Opportunities
Location(s): Chennai

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