Senior Medical Writer

GSK

Bengaluru Luxor North TowerPosted 26 days agoDiscoveredMatch locked

Full time

About the role

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary 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 analysed 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 organization

Responsibilities

Completes assignments independently or for more complex documents, under guidance of a mentor Authors 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. Preferred Qualification PhD or equivalent expertise (e.g., a master’s degree with a minimum of 2 years’ relevant experience) 8 years clinical regulatory writing experience in the pharmaceutical industry

Other Job-Related Skills

Possesses 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)

Working model This role is hybrid, based in India. You will spend core days in the office for collaboration and use flexible remote working for focused writing.

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com , so that we can confirm to you if the job is genuine.

Not included in the source posting: about the role, qualifications, benefits.

Skills

gcp

Who can apply

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