Team Lead/ Team Manager - Medical Writer

Neptune Consultants
  • Mumbai
  • Confidential
  • 4-8 years
  • 18 Mar 2015

  • R&D/ Research & Development, Medical Services

  • Hospitals/ Health Care, Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Position Summary Perform medical writing activities on the assigned project in a timely and efficient manner.

Technical Responsibilities (100%) Write regulatory (e.g., clinical study reports, protocols, narratives, investigators brochure) and publications (manuscripts, abstracts, posters) documents
Take ownership of the document
Follow Company or client QMP and track metrics (quality and timelines) specified for the project
Fill the defect tracker and track errors in every medical writing project
Coordinate a set of medical writing activities associated with a drug program therapy team
Review and QC all deliverables
Ensure that documents are approved and issued in accordance with timelines
Request data sources and attend client calls for medical writing deliverables kick-off meetings, review meetings and status updates
Follow ICH-GCP guidelines & writing style guides (client specific or AMA guidelines) while working on the medical writing deliverables
Follow applicable SOPs
Provide/receive trainings and contribute to knowledge sharing sessions
Provide support to the team and project manager when required
Provide support to the Team Lead in internal audits
Complete all client specific trainings and maintain training file

Competencies/Skill sets for this job

Medical Writing Study Reports Clinical Study Internal Audits

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Neptune Consultants