Principal Medical Writer Job at GSK, Mississauga, ON

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  • GSK
  • Mississauga, ON

Job Description

Site Name: Mississauga Milverton Drive
Posted Date: Jul 31 2025

Principal Medical Writer Role – Required Expertise

We are seeking an experienced professional with advanced medical writing expertise who can independently manage complex regulatory writing projects. This role demands a deep understanding of clinical trial designs, statistical analysis interpretation, and clinical document processes.

Key Experience Requirements:

  • 7+ years of advanced regulatory medical writing experience in the pharmaceutical industry, including protocols, clinical study reports (CSRs), briefing books, and summary modules.
  • Comprehensive knowledge of statistical and regulatory concepts, with the ability to write complex regulatory documents independently and without supervision.
  • Demonstrated success in leading and completing multi-document projects, such as serving as Lead Writer for a Common Technical Document (CTD) submission dossier, including authoring and overseeing several Module 2 documents.
  • This role requires exceptional clinical document expertise, strong planning and prioritization skills, and a commitment to driving continuous improvement and best practices.

Key Responsibilities include, but are not limited to:

  • Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
  • Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
  • Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
  • Demonstrated effectiveness in management of projects of increasing scope and complexity.
  • Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
  • Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
  • High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
  • Assess trends and patterns in text and statistical data and effectively organizes content and messages in clinical reports and summary documents.
  • Review reporting and analysis plans and provides critical input on the content and display of tables.
  • Familiarity with approaches to expedite document preparation such as review tools and automation.
  • Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
  • Effectiveness in both oral and written communications.

Required Qualifications

  • PhD or relevant working experience within the life sciences space.
  • Clinical regulatory writing experience in the pharmaceutical industry
  • Demonstration of leadership.
  • Experience in multicultural settings (to reflect our external customers/clients [health authorities/patients] and diverse environments with respect to dynamics of human interaction (including working with remote teams)
  • Ability to interpret, describe and document clinical data.
  • Working knowledge of International Committee for Harmonisation ICH)/Good Clinical Practice (GCP).
  • Computer skills and general computer literacy.
  • Excellent English language skills (verbal and written)

*LI-GSK

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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com .  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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.

Job Tags

Internship, Local area, Remote work, Worldwide,

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