Safety Writing

Description:

GSK is seeking a Medical Writing Associate Director, Safety Writing to lead the creation of high-quality aggregate safety reports and risk management plans to support regulatory submissions and ensure compliance with global standards. The role is based in Mississauga, Ontario, and is hybrid, offering flexibility to work both remotely and on-site.

In this position, you will collaborate with cross-functional teams including clinical, regulatory, and pharmacovigilance experts to deliver impactful and accurate documentation. The role requires strong leadership, project management, and the ability to interpret medical-scientific data across various therapeutic areas. As part of GSK’s commitment to excellence, you will also guide and mentor team members, contribute to process improvements, and ensure all documents meet regulatory requirements.

Key Responsibilities:

• Lead the development of aggregate safety reports and risk management plans.

• Ensure all documents comply with global regulatory requirements and organizational standards.

• Collaborate with cross-functional teams to gather and interpret clinical data effectively.

• Manage project timelines and resources to ensure timely delivery of high-quality documents.

• Mentor and guide team members and external writers to enhance skills and performance.

• Participate in process optimization initiatives to improve efficiency and document quality.

Qualifications and Requirements:

• Advanced degree (Master’s, PhD, or PharmD) in life sciences or related field.

• 6–8 years of experience in safety report development within pharmaceutical or CRO settings.

• Strong project management, planning, and communication skills.

• Ability to interpret medical-scientific data from diverse therapeutic areas.

• Knowledge of International Council for Harmonisation (ICH) guidelines and Good Clinical Practice (GCP).

• Preferred: Medical degree with hospital-based patient experience.

• Experience mentoring or training medical writers is advantageous.

Work Environment:

• Hybrid role with flexibility to work remotely and on-site in Canada.

• Inclusive, diverse, and growth-oriented workplace with focus on employee wellbeing and development.

Why Join GSK?

GSK is a global biopharmaceutical company focused on uniting science, technology, and talent to advance healthcare. The company operates in four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology. Employees at GSK thrive in an inclusive environment with continuous opportunities for professional development and wellbeing support.