Top Benefits
About the role
Site Name: Mississauga Milverton Drive
Posted Date: Jul 30 2025
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 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.
Top Benefits
About the role
Site Name: Mississauga Milverton Drive
Posted Date: Jul 30 2025
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 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.