Expert Scientific Writer

4 weeks ago


Bengaluru, India GSK Full time

**Site Name**: Bengaluru Luxor North Tower

**Posted Date**: Feb 14 2023
**Job Purpose**:
The Expert Scientific Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trials designs and interpretation of statistically analysed research data (clinical/epidemiological). He/she would be expected to drive and coordinate the process to draft, review and approve written assignments. The Expert Scientific Writer has extensive scientific expertise and will lead in the implementation of best practices and continuous improvement. He/she has the ability to plan and prioritize without supervision.

**Key Responsibilities**:

- Scientific Writing program/document management (i.e., identifying timelines for assignments according to strategic requirements and as agreed by teams) including tracking and reporting document.
- Provide training/coaching and/or advice to less experienced writers and to matrix teams on internal and external standards; Advise on resourcing solutions for assignments including supervision of less experienced or external writers where required
- Instructs logical and consistent structures for the presentation of data and takes an active role in facilitating solid understanding of scientific methodology in the design, conduct and interpretation of research. Participate in meetings to identify responses to be given to regulatory authorities. Ensuring high scientific integrity of data interpretation, following negotiation with internal and external partners.
- Ensures the consistency and quality level of all documents that are issued requiring mínimal quality check (QC) mandated rework. Ensures quality assurance for all written materials within scope (reports, protocols, ICFs etc) in line with ICH-GCP E3, E6 guidelines.
- Provides significant input to program objectives and accomplishments in a matrix and line team environment. Assures that the team has appropriate ongoing and summary information on study document progress and results, raises concerns /issues in a timely, open and appropriate manner.
- Demonstrates skills in effectively managing assignments (including multiple priorities and responsibilities) and assures assigned milestones are achieved within the established time frames.
- Ensure the timely dissemination of relevant information and/or documents to each target audience.
- Ability to work within a complex matrix structure (with Clinical Research and Development Lead, Project Level CRDL, Regional Medical Directors and Advisors, Study Delivery Leads (SDL), Study Data Managers (SDM), Biostatisticians, other Scientific Writers) and drive the process. Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in project delivery.

**Required**:

- Post-graduate degree in life sciences or medical background or equivalent expertise. Preferred PhD
- Proficiency in basic immunology and area of assigned vaccine project.
- Demonstrates advanced knowledge of scientific methodology in the design, conduct and description of clinical research.
- Demonstrates expertise in analyzing and describing clinical results.
- Understands the organization of study reports and scientific presentations.
- Possesses advanced knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
- Possesses advanced knowledge of statistical principles used in clinical research
- Possesses very good computer skills and general computer literacy.
- Excellent command over English language (verbal and written).

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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

**Important notice to Employment businesses/ Agencies**

**GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is


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