Experience: min 2 years of experience.

The location would be Bangalore.

Interested candidates can apply through the link below or send their CV on alpana.x.das@gsk.com

Job Purpose Of The Scientific Writer

The Scientific 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.

Knowledge/Education Required

Minimum Level of Education Required –MSc or MPharm

Area of Specialization – Life Sciences

Why is it required?– This is the minimum post graduate qualification required for this entry grade. The role will require a good understanding of complex regulatory writing processes including data interpretation & skills to communicate information to target audiences. The post graduate qualification should reflect experience of independently conducting scientific research, data interpretation and ability to write for a scientific audience. A PhD would warrant the next level entry grade.

Previous Experience Required

Minimum Level of Job-Related Experience Required –

• Up to 2 years writing experience in the pharmaceutical industry is a plus.
• 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 Harmonization (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 is this level of experience required? – This level of experience will provide expertise for assigned activities and facilitate working independently on some projects.

Knowledge & Application – The level of knowledge required will be applied to work on assignments (to some extent) independently, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content. 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.

Problem Solving & Innovation

• Actively participates in document planning and review meetings.
• Demonstrates understanding of how to interpret and describe clinical data
• Proactively raises and discusses concerns/ issues in an open and timely manner within the global Medical Writing Team
• Promotes high medical writing standards by pointing out obvious flaws and proposing alternatives.

Interaction

• Participates in document planning and review meetings.
• Raises and discusses concerns/ issues in an open and timely manner within the global team at GSK Pharma
• Establishes network of communication and builds these relationships with stakeholders to facilitate efficient execution of assignment
• Has ability to interpret and describe clinical data and discuss with team.
• Promotes high medical writing standards by pointing out obvious flaws and proposing alternatives.

Multi-Cultural Requirements : The role requires interactions in multicultural settings and in diverse environments for discussion with peers, project team members and stakeholders. The role also may require interactions with co-workers who are in virtual remote teams.

Impact

The role will contribute to delivery of clinical R&D project milestones and ensures consistently high quality by doing the following:

• Completes assignments under guidance of a mentor (this may include sections, or whole documents and following defined templates).
• Promotes high medical writing standards by pointing out obvious flaws
• Has ability to interpret, describe and document clinical data and discuss with team
• May attend planning, coordination and review meetings.