# Principal Medical Writer

**Company**: GSK
**Location**: Canada, ON
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: CAD118,000 to CAD168,000
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Mississauga-Milverton-Drive/Principal-Medical-Writer_446435-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_8070a683-cc8

## Description

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.

The Principal Medical Writer is a seasoned expert who owns complex safety writing deliverables end-to-end. In this role, they independently lead the authoring of high-impact safety documents,such as aggregate reports and Risk Management Plans (RMPs),translating complex safety data and analyses into clear, compelling outputs.

**Responsibilities**

- Independently lead preparation of complex clinical and post-market safety documents (e.g., DSURs, PSURs/PBRERs, ACOs, PADERs/PAERs, RMPs, and responses to regulatory authority questions).

- Operate effectively within a global, complex matrix organization, working autonomously and confidently influencing stakeholders on process discipline, quality standards, and “how” work should be done.

- Lead cross-functional teams to develop content strategy, coordinate contributions, manage review schedules and timelines, and ensure high-quality, fit-for-purpose documents.

- Provide oversight to co-authors, vendor writers, and teams of writers,serving as a mentor/buddy, ensuring the quality of contributions.

**Basic Qualifications**

- Bachelor’s degree in life sciences, health sciences, pharmacy, nursing or a related field.

- Minimum 5 years of advanced medical/regulatory safety writing experience in pharmaceutical, biotech or clinical research settings.

- Advanced understanding of, and ability to apply, statistical, regulatory and medical communication concepts.

- In-depth working knowledge of relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA).

**Preferred Qualifications**

- Advanced degree (PhD, PharmD, MSc, MPH) or equivalent scientific training.

- Advanced safety writing skills with expertise across most key safety document types.

- Comfort interpreting statistical outputs and collaborating with statisticians.

- Highly collaborative and capable of leading cross-functional, multicultural, and hybrid/distributed teams.

**What you will gain**

You will join a team focused on patient impact and continuous learning. You will develop technical and strategic skills in regulatory writing, submission planning and cross-functional collaboration.

## Skills

### Required
- Medical Writing
- Regulatory Submissions
- Scientific Writing
- Communication
- Decision Making

### Nice to have
- Advanced safety writing skills
- Statistical analysis
- Collaboration
- Leadership
- Mentoring

---

Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Mississauga-Milverton-Drive/Principal-Medical-Writer_446435-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)