Senior Medical Writer

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 : 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 organizations.

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.

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals :

Up to 5 years in clinical and regulatory writing experience in the pharmaceutical industry

Master’s degree or higher in life sciences, pharmacy, medicine or a related scientific discipline.

Demonstrated experience in preparing clinical regulatory documents (CSRs, clinical summaries and overviews).

Good understanding of clinical trial design, data analysis and interpretation of safety and efficacy results.

Strong written and verbal English communication skills.

Comfortable working in a complex matrix environment and managing multiple priorities.

Preferred Qualification

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).

Working model

This role is hybrid, based in India. You will spend core days in the office to collaborate with colleagues and use flexible remote working for focused writing.

In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD103,000 to CAD153,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.

Why GSK?

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 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.