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Associate Director Medical Writer

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GSK

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Location:
Canada , Mississauga

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

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Job Description:

The Associate Director Medical Writer is an individual expert who can manage and prepare clinical/regulatory documents in support of the clinical project strategy. As well as being able to independently execute complex writing assignments, this role has a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data. He/she would be expected to provide major input into marketing application submission planning and execution in a variety of other clinical documents. This role has extensive clinical document expertise and will champion change in the implementation of best practices and continuous improvement

Job Responsibility:

  • Contribute to the planning, authoring, review, and approval of clinical/regulatory documents for medical writing project to achieve a successful outcome within the required timelines
  • Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level
  • Provide major input to submission teams in development of submission plans, timelines, document content and dependencies
  • Advises on or recommends methods for achieving accelerated timelines, including review tools and automation
  • Actively contribute to development of training materials for clinical document preparation
  • provides mentoring and/or training on clinical documentation and submission planning to individuals or teams
  • Champion change and contributes to departmental or cross-functional process improvement initiatives and develops/revises standards for GSK submission documents
  • Effectively contribute to process improvement activities

Requirements:

  • PhD or relevant working experience within the life sciences space
  • Proven track record in writing clinical/regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
  • Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements
  • Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide
  • Demonstrated effectiveness in management of projects of increasing scope and complexity
  • Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome)
  • Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions
  • High-level computer skills and general computer literacy
  • Demonstrated knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research
  • Ability to interpret clinical data, assess trends and patterns in text and statistical data, and effectively organize content and messages in clinical reports and summary documents
  • Review reporting and analysis plans and provides critical input on the content and display of tables
  • Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas)
  • Effectiveness in both oral and written communications
  • Possesses a good understanding of drug development
  • Possesses working knowledge of International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP)
  • Excellent English language skills (verbal and written)
What we offer:
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes

Additional Information:

Job Posted:
February 21, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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