Principal Medical Writer

7 days ago


Mississauga, Canada GSK Full time

**Site Name**: Mississauga Milverton Drive
**Posted Date**: Oct 9 2025
**Principal 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:
Our approach to R&D

**Position Summary**
Are you passionate about creating high-quality medical and scientific documents that make a meaningful impact? In this role, you will lead the development of complex regulatory documents, ensuring they meet global standards and support GSK’s mission to get ahead of disease together. You’ll collaborate with cross-functional teams, contribute to regulatory submissions, and help shape the future of medical writing at GSK. This is an opportunity to grow your expertise, work on impactful projects, and be part of a team that values innovation, inclusion, and excellence.

**Responsibilities**
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

- Lead the development of clinical regulatory documents, including protocols, clinical study reports, investigator brochures, and regulatory submission documents.
- Collaborate with cross-functional teams to ensure documents are accurate, clear, and aligned with regulatory requirements.
- Manage timelines and deliverables for multiple projects, ensuring high-quality outputs within deadlines.
- Provide strategic input into clinical development plans and regulatory submission strategies.
- Mentor and guide junior medical writers, fostering a culture of continuous learning and improvement.
- Identify opportunities to enhance processes and implement best practices in medical writing.

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

- Bachelor’s degree in life sciences, health sciences, or a related field.
- At least 7 years of experience in medical or scientific writing within the pharmaceutical or healthcare industry.
- Proven ability to independently write and manage complex regulatory documents.
- Strong understanding of International Council for Harmonization (ICH) guidelines and Good Clinical Practice (GCP).
- Excellent written and verbal communication skills, with attention to detail.
- Experience managing multiple projects and meeting deadlines in a fast-paced environment.

**Preferred Qualifications**
If you have the following characteristics, it would be a plus:

- Advanced degree (e.g., PhD, PharmD, MPH, MS) in life sciences or a related field.
- Experience leading regulatory submission projects, including Common Technical Document (CTD) dossiers.
- Familiarity with statistical concepts and ability to interpret clinical data.
- Strong problem-solving skills and ability to adapt to changing priorities.
- Experience working in multicultural or remote team settings.
- Demonstrated ability to mentor and develop team members.

This role is hybrid, with flexibility to work on-site 2-3 days a week in our Mississauga office.

**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.

**Important notice to Employment businesses/ Agencies



  • Mississauga, Canada GSK Full time

    **Site Name**: Poznan Business Garden, Mississauga Milverton Drive, Warsaw Rzymowskiego 53 **Posted Date**: Jan 8 2025 **_ Principal Medical Writer_** Specifically for this position: - 7+ years of advanced regulatory medical writing experience (protocol, CSRs, briefing books, summary modules), prior experience in oncology and understanding of clinical...


  • Mississauga, Canada GSK Full time

    Site Name: Mississauga Milverton DrivePosted Date: Jul 3 2025The Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data. He/she would be expected to drive and coordinate...


  • Mississauga, Ontario, Canada GSK Full time

    Job Title: Principal Medical Writer Business IntroductionAt 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...


  • Mississauga, Canada GlaxoSmithKline Full time

    Job Purpose The Medical Writing Manager 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. He/she would be expected to drive and coordinate the process to draft, review and approve written...


  • Mississauga, Canada GlaxoSmithKline Full time

    Job Purpose The Medical Writing Manager 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. He/she would be expected to drive and coordinate the process to draft, review and approve written...

  • Medical Writer

    5 days ago


    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive **Posted Date**: Jan 31 2025 9**Job Purpose** The 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 medical writer...

  • Medical Writer Ii

    7 days ago


    Mississauga, Canada Ergomed Full time

    **Company Description** We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...


  • Mississauga, ON, Canada GSK Full time

    Job Title: Principal Medical WriterBusiness IntroductionAt 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...


  • Mississauga, ON, Canada GSK Full time

    Job Title: Principal Medical WriterBusiness IntroductionAt 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...


  • Mississauga, Canada Baylis Medical Technologies Inc. Full time

    **Title**: Corporate Story Writer **Job Type**: Contract **Duration**: 6 months **A peek into purpose** **Role commitments** - **Historical Research**: Conduct thorough research to gather detailed information on the company's history, including significant milestones, changes, and achievements. This will involve reviewing archival materials, previous...