الوصف الوظيفي
Years of Experience: 6 - 9 yearsSkill Set / Exposure: Clinical and Regulatory document writing, CSR, Briefing Document, Module (m2.5, m2.7.1 & m2.7.2).Work Location: BengaluruJob Purpose:The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content.The senior medical writer understands clinical trials design and interpretation of statistically analyzed clinical research data.He/she would be expected to drive and coordinate the process to draft, review and approve written assignments and should be able to meet the quality standards of the global organization.The Senior Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organizations.Key Responsibilities:Completes assignments independently or for more complex documents, under guidance of a mentorAuthors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.Ensures high integrity of data interpretation, following negotiation with document team.Ensures the consistency and quality level of all documents that are issued.Actively participates in all planning, coordination and review meetings.Ability to work on 2-3 assignments simultaneously.Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives.Works directly with a diversity of roles at different levels within GSK (e.g., Clinical Leads, Asset Leads, Study Delivery Leads (SDL), Biostatisticians, other Medical Writers).Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments.Education Requirements:PhD or equivalent expertise (e.g., a master’s degree with a minimum of 2 years’ relevant experience)Job Related ExperienceUp to 5 years clinical regulatory writing experience in the pharmaceutical industryPossesses a good understanding of basic drug development.Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.Demonstrates understanding of how to interpret, describe and document clinical data.Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).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 organisation 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, 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/ AgenciesGSK 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. 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