Medical Writing Associate Director, Safety Writing

GlaxoSmithKline; Mississauga; Hybrid; CAD 100,000 - 130,000; Full time

Job summary

A leading biopharma company in Mississauga is seeking a Medical Writing Associate Director to lead the creation of aggregate safety reports and collaborate with teams to ensure compliance with global standards. Candidates must have an advanced degree and several years of experience in safety report development, along with strong leadership skills. The role offers hybrid work flexibility.

Qualifications

• 6-8 years of experience in developing safety reports
• Ability to understand medical-scientific data across therapeutic areas
• Knowledge of ICH guidelines and GCP

Responsibilities

• Lead the creation of aggregate safety reports and risk management plans
• Collaborate with teams to gather and interpret clinical data
• Manage timelines for high-quality document delivery

Skills

Strong leadership

Strategic thinking

Attention to detail

Project management

Effective communication

Education

Advanced degree (Master’s, PhD, or PharmD) in life sciences

Job description

Medical Writing Associate Director, Safety Writing page is loaded

Medical Writing Associate Director, Safety Writing

Apply locations Mississauga Milverton Drive time type Full time posted on Posted Yesterday time left to apply End Date: September 5, 2025 (30+ days left to apply) job requisition id 425619

Position Summary

Are you passionate about medical writing and eager to make a meaningful impact on patient safety? In this role, you will lead the development of high- aggregate safety reports and risk management plans that support regulatory submissions and ensure compliance with global standards. You’ll collaborate with cross-functional teams, including clinical, regulatory, and pharmacovigilance experts, to deliver clear, accurate, and impactful content. We value candidates who bring strong leadership, strategic thinking, attention to detail, and a commitment to excellence in medical writing.

Responsibilities
- Lead the creation of aggregate safety reports and risk management plans.
- Ensure documents meet global regulatory requirements and align with organizational standards.
- Collaborate with cross-functional teams to gather and interpret clinical data for accurate and effective communication.
- Manage timelines and resources to ensure timely delivery of high-quality documents.
- Provide guidance and mentorship to team members and external writers, fostering a culture of continuous improvement.
- Contribute to process optimization initiatives to enhance efficiency and document quality.

Basic Qualifications:

Advanced degree (Master’s, PhD, or PharmD) in life sciences or a related field.
- 6-8 years of experience in the development of safety reports in a post-market setting within the pharmaceutical/ Contract Research Organization industry.
- Proven ability to write and manage
- Strong project management skills, including planning, communication, and matrix leadership.

Ability to understand medical-scientific data from a broad range of therapeutic areas
- Knowledge of International Council for Harmonisation (ICH) guidelines and Good Clinical Practice (GCP).

Preferred Qualifications:

A medical degree with hospital-based patient experience is advantageous.
- Strong communication skills, with the ability to present ideas clearly to diverse audiences.

Ability to plan work to meet deadlines and effectively handle multiple priorities.
- Experience mentoring or training team members in medical writing best practices.

Work Environment:
This role is hybrid, with flexibility to work remotely and on-site in Canada as needed.

Join us in shaping the future of medical writing and making a difference in patient safety. We look forward to welcoming your expertise and enthusiasm to our team!

*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 [e-mail] . Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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. Find out more on our career site .