Ville : Toronto

Catégorie : Autre

Industrie : Healthcare

Employeur : GSK

Job Title: Principal Medical Writer

Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more: Our approach to R&D

Position Summary
The Principal Medical Writer is a senior subject-matter expert who independently drives the creation of high-stakes safety documents—such as aggregate reports and Risk Management Plans—by combining deep regulatory knowledge with sharp interpretation of safety data. This role leads end-to-end production of complex deliverables, navigates challenging data analyses and critical safety issues, and champions continuous improvement by promoting best practices and adopting new tools and technologies.

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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.

Why You?
Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• Bachelor's degree or equivalent in a scientific discipline.

• 5 years of advanced safety writing experience in the pharmaceutical domain including summarization and interpretation of complex data and preparation of complex documents.
• Experience authoring relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA) pertaining to clinical trial conduct, pharmacovigilance, and document-specific requirements and 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

​Preferred Qualification

If you have the following characteristics, it would be a plus

• Advanced safety writing skills with expertise in most safety document types.
• Experience in a highly collaborative environment, 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.

Working Style
This role is based in Mississauga, Canada and is hybrid. You will work on-site part of the week and remotely the remainder. Exact on-site days will be agreed with your manager.

What you will gain
You will gain exposure to complex development programs and deepen skills in regulatory writing, submission planning and cross-functional collaboration. You will work with talented colleagues who value inclusion, learning and patient-focused impact.
Ready to apply?
If this role aligns with your skills and goals, we want to hear from you. Please apply and tell us how your experience will help shape treatments that matter.

#LI-Hybrid

Pourquoi GSK?
Allier science, technologie et talent pour vaincre ensemble la maladie.

GSK est une entreprise biopharmaceutique mondiale dont la mission est de réunir la science, la technologie et le talent pour prendre ensemble de l'avance sur les maladies. Nous visons à avoir un impact positif sur la santé de 2,5 milliards de personnes d'ici la fin de la décennie, en tant qu'entreprise prospère et en croissance où les gens peuvent s'épanouir. Nous prenons de l'avance sur les maladies en les prévenant et en les traitant grâce à l'innovation dans les médicaments spécialisés et les vaccins. Nous nous concentrons sur quatre domaines thérapeutiques : les maladies respiratoires, l'immunologie et l'inflammation; l'oncologie; le VIH; les maladies infectieuses – pour avoir un impact à grande échelle sur la santé.

Les gens et les patients partout dans le monde comptent sur les médicaments et les vaccins que nous produisons; c'est pourquoi nous nous engageons à créer un environnement où nos employés peuvent s'épanouir et se concentrer sur ce qui compte le plus. Notre culture, qui repose sur l'ambition pour les patients, la responsabilité de la portée et le fait de faire ce qui est juste, constitue la base de la manière dont nous tenons nos engagements ensemble pour les patients, les actionnaires et nos employés.

GSK est un employeur offrant l'égalité des chances. Cela garantit que tous les candidats qualifiés recevront une considération égale pour l'emploi sans distinction de race, de couleur, de religion, de sexe (y compris la grossesse, l'identité de genre et l'orientation sexuelle), de statut parental, d'origine nationale, d'âge, de handicap, d'informations génétiques (y compris les antécédents médicaux familiaux), de service militaire ou de toute autre base interdite par la loi fédérale, étatique ou locale. GSK s'engage à accueillir les personnes handicapées. Si vous avez besoin d'un aménagement à n'importe quelle étape du processus de candidature ou si vous souhaitez plus d'informations sur nos politiques d'aménagement, veuillez nous contacter à canada-recruitment@gsk.com. Veuillez ne pas envoyer de CV à cette adresse e-mail et postuler plutôt via le processus de candidature en ligne de cette annonce.

Avis important destiné aux services/agences de placement

GSK n’accepte pas les propositions des services/agences de placement en vue de pourvoir les postes affichés dans le présent site. Ces services/agences doivent s’adresser au service d’approvisionnement/des ressources humaines de GSK pour obtenir une autorisation écrite avant de lui proposer des candidats. Cette autorisation est une condition préalable à toute entente (orale ou écrite) entre le service/l’agence de placement et GSK. Sans cette autorisation écrite, toute mesure de la part du service/de l’agence de placement doit être considérée comme avoir été appliquée sans le consentement ni l’entente contractuelle de GSK. Par conséquent, GSK ne peut pas être tenue responsable des honoraires attribuables à de telles mesures ni à quelque recommandation que ce soit de la part du service/de l’agence de placement en ce qui concerne sa proposition de candidature en vue de pouvoir un poste annoncé dans le présent site.