Principal Medical Writer - Safety Writing

GSK; Mississauga; On-site; CAD 90,000 - 120,000; Full time

Job summary

A leading biopharma company in Mississauga is seeking a Principal Medical Writer to independently manage the preparation of complex safety documents. The ideal candidate will have a master's degree, at least 7 years of experience in safety writing, and the ability to lead cross-functional teams. This role requires expertise in regulatory standards and excellent English proficiency. A collaborative environment with opportunities for training and improvement initiatives awaits.

Qualifications

• Minimum of 7 years of advanced safety writing experience in the pharmaceutical domain.
• In-depth knowledge of relevant regulatory guidance (ICH, GVP, FDA, EMA).
• Advanced understanding of statistical and medical communication concepts.

Responsibilities

• Lead preparation of complex clinical and post-market safety documents.
• Provide oversight to co-authors and ensure quality.
• Develop and deliver training on medical writing topics.

Skills

Advanced safety writing skills

Excellent English language proficiency

Ability to lead cross-functional teams

Ability to navigate multicultural settings

Education

Master’s degree or equivalent in a scientific discipline

Tools

Authoring and reviewing tools

Automation/technology platforms

Job description

Job Purpose:

The Principal Medical Writeris an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of safety documents (e.g., aggregate reports and Risk Management Plans [RMPs]) and interpretation of safety data. They must demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues. This role requires extensive safety document expertise and will support continuous improvement and the implementation of best practices and adoption of new tools and technology.

Key Responsibilities:

• Independently lead preparation of complex clinical and post-market safety documents, including but not limited to Development Safety Update Reports (DSURs), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Addendums to Clinical Overviews (ACOs), US Periodic Adverse Drug Experience Reports/Periodic Adverse Experience Reports (PADERs/PAERs), RMPs and responses to regulatory authority questions.
• Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions.
• Lead cross-functional teams in document preparation including but not limited to development of content strategy, coordination of content contributions, organization of review schedules, and project timelines.
• Work in a matrix team to ensure delivery of high-quality, fit-for-purpose documents that reflect accurate interpretation of associated safety, clinical, and statistical data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
• Understand the interdependencies of various contributing functions (e.g., safety, regulatory, clinical, epidemiology, statistics and programming).
• Anticipate and evaluate complex situations and problems, resolving them by leveraging scientific and operational knowledge in collaboration with stakeholders.
• Assess trends and patterns in text and statistical data and effectively organize content and messages in safety documents.
• Use approaches to expedite document preparation, including authoring and reviewing tools, as well as other automation/technology platforms.
• Serve as a mentor for less experienced writers.
• Develop and deliver training on medical writing topics.
• Lead initiatives to improve medical writing processes.
• Contribute to vendor oversight as needed.

Education Requirements:

Master’s degree or equivalent in a scientific discipline. A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in hospital-based environment, would be an advantage.

Job Related Experience:

• Minimum of 7 years of advanced safety writing experience in the pharmaceutical domain including summarization and interpretation of complex data and preparation of complex documents.
• In depth working knowledge of:
  • Relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA) pertaining to clinical trial conduct, pharmacovigilance, and document-specific requirements.
  • Core cross-functional clinical research roles and procedures, and how they relate to document strategy and operational preparation.
• Experience in multiple therapeutic areas to have confidence to dive into these areas without lead time.
• Advanced understanding of and ability to apply the statistical, regulatory, and medical communication concepts needed to independently write complex safety documents.

Other Job-Related Skills

• Advanced safety writing skills with expertise in most safety document types.
• Highly collaborative, capable of leading cross‐functional team members, negotiating solutions, and advising them on document structure and content as needed.
• Skilled in navigating multicultural settings, ensuring effective collaboration with diverse customers and clients, such as health authorities and patients, while adeptly collaborating with remote teams.
• Able to independently lead multiple projects simultaneously and deliver multiple high-quality documents on schedule.
• Advanced computer skills and general computer literacy.
• Excellent English language proficiency, both verbal and written

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

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