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Medical Writer - CSR Writing
  • Job ID: 129366
  • Employment Type: Full Time
  • Country: India
  • State/Province: Haryana
  • City: Gurgaon
  • Zip/Postal Code: 122001
  • Job Category: Operational Services
  • Internal Job Description:
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  • Project End Date:
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Overview

 Do you want to work in an environment and culture where you can thrive, develop and advance?

A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognise our people by providing valuable benefits and a quality of life balance.

An opportunity has arisen for a Medical Writer at Senior Associate level in Bangalore/Gurgaon.


Responsibilities

  • Delivery of outsourcing engagements, Support Kinapse operational team, and Quality management under minimal supervision and with guidance from more senior service line colleagues
  • Author clinical study documents or documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries 
  • Prepare external scientific communications i.e.  manuscripts, abstracts,  response documents, etc.
  • Ensure protocol and results summaries to support clinical trial disclosure commitments
  • Systematically perform quality control checks of documents prepared by colleagues against pre-specified check-list generated in the project or SO
  • Perform detailed analyses on a planned and ad hoc basis, relating to medical writing or medical information processes and their outputs
  • Assist in mentoring and training of team members depending upon project requirement
  • Participates in project-specific meetings with client colleagues, if required
  • Performs detailed analyses on a planned and ad hoc basis, relating to the medical writing processes and their outputs

Job Requirements

  • Educational qualifications: A minimum of a scientific graduate degree in life sciences.
  • Candidates may have a higher degree or a proven track record in a pharmaceutical or CRO company.
  • Good knowledge of regulatory requirements or guidance pertinent to the service line.
  • Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines
  • Clear written and verbal communication skills.
  • Good knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required.

 If you want to be part of a progressive, forward-thinking company and want to make a difference then we want to hear from you.

We believe that Diversity & Inclusion are central to a dynamic, exciting and innovative organization. To review our D&I policy please visit https://kinapse.com/diversity-inclusion