Kinapse

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.

Trial Master File (TMF) Document Specialist

Updated: April 29, 2021
Location: Bengaluru, KA, India
Job ID: 130817


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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 recognize our people by providing valuable benefits and a quality of life balance.

 An opportunity has arisen for a Regulatory Associate (TMF) for a role that can be home based. A Regulatory Associate will play an important role in executing regulatory projects for Kinapse’s global clients.  A Regulatory Associate will work as part of high-performing teams on challenging assignments involving the processing of regulatory information. Regulatory Associates will report to a Regulatory Manager/Scientist for their day-to-day project work.  Regulatory activities will be undertaken according to defined processes and operating procedures, which will be subject to internal and external audit.

Responsibilities

  • Performs support tasks related to the set-up, maintenance and close out of electronic Trial Master Files (TMF).
  • Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments.
  • Responsible for adding meta data to electronic TMF documentation.
  • Proactively completely assigned activities, escalates issues as necessary, and shares TMF-related knowledge with colleagues.

Job Requirements

  • A minimum of a Post graduate degree from a well-known institution.
  • Candidates will have any one of the following qualifications from a reputed university; Masters in Pharmacy (preferably Pharmaceutics, QA, Industrial Pharmacy) or Ph.D or Post Graduate degree in Life Sciences.
  • Some experience in a clinical trials environment preferred.
  • Some knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology preferred.
  • Familiarity with electronic TMF system preferred.
  • Strong verbal, written and organisational skills with a team-oriented approach.
  • Proficiency in Microsoft Office Suite and Adobe Acrobat.

 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


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