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Medical Writer

Medical Writer

GSKINDIA
30+ days ago
Job description

Years of Experience : 3 - 5 years

Skill Set / Exposure : Clinical and Regulatory document writing, Protocol, CSR and Modules (m2 & m5).

Work Location : Bengaluru

Job Purpose :

  • The Medical Writer is expected to work under guidance of a mentor or independently, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content.
  • The writer understands trial designs and interpretation of statistically analyzed clinical research data.
  • The writer should be able to meet the quality standards of the global organization.
  • The Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organizations.

Key Responsibilities :

  • Completes assignments under guidance of a mentor or independently (this may include sections, or whole documents).
  • Authors clinical regulatory documents following defined templates.
  • Independently builds and expands capabilities to work on increasingly complex assignments.
  • Understands the importance of consistency and quality level for all documents.
  • Establishes network of communication and continuously builds these relationships with stakeholders to facilitate efficient execution of assignment.
  • Participates in document planning and review meetings.
  • Proactively raises and discusses concerns / issues in an open and timely manner within the global Medical Writing Team.
  • Promotes high scientific and medical writing standards by pointing out obvious flaws and proposing alternatives.
  • Interprets and communicates clinical data clearly and succinctly and at an appropriate level for the audience.

    • Education Requirements :

  • MSc Life Sciences or MPharm.

    • Job Related Experience :

  • Up to 2 years writing experience in the pharmaceutical industry is a plus.

    • Other Job-Related Skills :

  • Demonstrates knowledge of scientific methodology in the design, conduct and description of clinical research.
  • Demonstrates understanding of how to interpret, describe and document clinical data.
  • Ability to understand importance of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
  • Possesses good working knowledge of statistical principles used in clinical research.
  • Shows good attention to detail.
  • Possesses necessary computer skills and general computer literacy.
  • Excellent English language skills (verbal and written).

    • Why GSK?

    Uniting science, technology and talent to get ahead of disease together.

    GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organization where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory / immunology and oncology).

    Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their well-being. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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    Locations : Bengaluru Luxor North Tower

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    Medical Writer • INDIA