Job title: Expert Scientific Writer

Company: GlaxoSmithKline

Job description: Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Sep 1 2022 Ready to help shape the future of healthcare? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease

Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Sep 1 2022 Ready to help shape the future of healthcare 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 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 wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. 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 minimal 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. Knowledge/ Education / Previous Experience Required:- 1. Minimum Level of Education – Post-graduate degree in life sciences or medical background or equivalent expertise 2. Preferred Level of Education – PhD or equivalent Job-Related Experience:- Minimum Level of Job-Related Experience required Generally at least 5 years experience in Scientific/Medical Writing within a pharma environment. Needs to be a subject matter expert with a solid understanding of the science and complex regulatory environment. Job-Related Experience sections above that are required for the job:- 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). At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. .LI-GSK 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 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 wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. 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 refundable. 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Expected salary:

Location: Bangalore, Karnataka

Job date: Sat, 03 Sep 2022 22:20:44 GMT

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