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 timeIndustry: PharmaceuticalFunctional Area: PharmaceuticalRole Category: Clinical Research AssociateRole/Responsibilies: PLS Writing