Job Title

Job Offer : Regulatory Data and Content Professional - Senior Medical Writer Location : Mississauga Work Model : Hybrid - 3 days onsite Start Date : April What we will accomplish together This team, is responsible for end-to-end data interpretation, generation and execution of content strategy, insight generation to guide submission strategy, and leadership of submission planning and management for clinical projects in order to develop and maintain product permits/licenses to meet the needs of patients. They understand how data and information contribute to the strategy and quality of submissions, and thus, deliver high-quality submissions to global Health Authorities for products throughout their development lifecycle to facilitate reviews and approvals. They ensure audit and inspection readiness and representation. Additionally as a member of the team, individuals understand how data and information contribute to the quality of submissions Your mission (should you choose to accept it!) As a member, you will drive and manage data interpretation and content, including medical writing, from initiation to approval, developing data and content standards, driving and articulating key messages, content creation, strategic reuse of content, and implementing automation and next-generation systems and tools. Your daytoday responsibilities will include: Leads a team of Content Strategists and/or cross-functional teams in development and execution of the content strategy for submission to global regulatory authorities in accordance with applicable regulatory guidelines/Roche standards/SOPs. (include the Clinical Dossier and/or Suite of Safety reports for drugs or medical devices). Plans content and creates timelines for the production and review of documents, ensuring alignment with overall project timelines where appropriate. Reviews documents for organization, clarity, scientific standards, and consistency of content, data, and messaging. Resolves issues with cross-functional contributors. Ensures compliance with regulatory requirements and internal processes Is a key strategic participant in functional and cross functional teams and actively contributes to best practices and continuous improvement initiatives and projects Partnering with key stakeholders, working on the molecule portfolio, or continuing to key initiatives that shape our technical, business and healthcare environments. Maintains up-to-date knowledge of key regulatory, scientific, and medical topics relevant to drug development and disease/therapeutic areas May act as a mentor to new or less experienced Content Strategists You: Degree in Life Sciences or equivalent with 5 years of relevant experience in the pharmaceutical/biotechnology industry, demonstrating independent project delivery and leadership. Experience in leading cross-functional teams. Familiar with regional/global drug and device development processes, regulations, and guidelines (e.g., GxP, GCP, ICH, ISO, and MDR/IVDR) and an understanding of GVP and GCP principles, including data integrity. Demonstrated expertise in clinical, safety and/or device regulatory documentation throughout the product lifecycle, from early development through post-marketing activities. Ability to independently analyze and synthesize data and non-clinical and clinical concepts from a broad range of disciplines. Proven ability to drive outcomes in global filings (strongly preferred) and other regulatory projects by collaborating across diverse, cross-functional teams, leveraging strong communication and interpersonal skills to build trust, foster collaboration, and resolve conflicts in matrixed environments. Excellent administrative and project planning skills, with proficiency in G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault; detail-oriented, creative thinker with a curiosity to learn and adapt to change, and fluent in English (verbal and written). Astek Benefits Up to 4 weeks of vacation plus 5 floating days Competitive group insurance plan, including telemedicine and an Employee Assistance Program (EAP) Public transportation reimbursement Mobile phone/plan reimbursement Reimbursement of professional association fees (e.g., OIQ) Annual fitness & sports allowance Annual IT equipment allowance Employee referral program Social activities (5@7, team buildings, etc.) Lets Meet! You recognize yourself in this job and Astek sounds like a great fit? Apply directly through this posting so Justine, our Talent Acquisition Specialist , can contact you for an initial conversation. Then, Julien, your future Manager , will meet with you to discuss the role, your experience, and your aspirations! Our Strengths Joining Astek means choosing: A career accelerator, where every project is a chance to grow Access to a wide variety of technically exciting projects for clients and internally Personalized support to build a tailored professional path Continuous learning through our internal training Academy A friendly and inclusive work environment backed by certified HR practices: #TopEmployer2026 #BestManaged #ISO9001 #ISO14001 #ISO27001 About Astek Canada Since 1999, Astek Canada has specialized in IT consulting and engineering, successfully supporting the development strategies of its clients. Guided by shared values, the company puts client needs at the center of everything it does. Astek Canada counts over 600 collaborators across Montreal, Toronto, and Vancouver. With innovation at the heart of digital transformation, Astek Canada helps organizations adopt emerging technologies and navigate their digital journey. --- Offre demploi : Professionnel des donnes et du contenu rglementaire Rdacteur mdical senior Localisation : Mississauga Mode de travail : Hybride - 3 jours sur site Dbut : Avril Le masculin est utilis pour allger lannonce. Ce que nous allons accomplir ensemble : Le dpartement Pharma Development Regulatory (PDR) est une organisation rglementaire flexible, audacieuse et distinctive. Il prend des dcisions rapidement et de manire stratgique mesure que lenvironnement et le paysage voluent. Le PDR , est responsable de linterprtation des donnes de bout en bout, de la cration et de lexcution de la stratgie de contenu, de la gnration dinsights pour guider la stratgie de soumission, ainsi que du pilotage de la planification et de la gestion des soumissions pour les projets cliniques du portefeuille, afin de dvelopper et de maintenir les autorisations et licences des produits pour rpondre aux besoins des patients. Votre mission (si vous lacceptez !) : En tant que membre, vous piloterez et grerez linterprtation des donnes et le contenu y compris la rdaction mdicale depuis linitiation jusqu lapprobation. Vous dvelopperez des standards de donnes et de contenu, porterez et articulerez les messages cls, crerez le contenu, encouragerez la rutilisation stratgique du contenu et mettrez en uvre des systmes et outils dautomatisation et de nouvelle gnration. Votre quotidien sera rythm par : Piloter une quipe de Content Strategists et/ou des quipes multifonctionnelles pour construire et excuter une stratgie de contenu aligne aux exigences des autorits rglementaires internationales. Dfinir, planifier et coordonner la production des documents rglementaires cls (dossiers cliniques, rapports de scurit). Assurer la cohrence, la clart et la rigueur scientifique des livrables. Collaborer troitement avec les parties prenantes pour rsoudre les enjeux et garantir la conformit aux exigences internes et externes. Contribuer des projets damlioration continue, dvelopper des standards, favoriser la rutilisation stratgique du contenu et soutenir ladoption doutils de nouvelle gnration. Vous : Diplme en sciences de la vie ou quivalent. Minimum 5 ans dexprience dans lindustrie pharmaceutique/biotech avec gestion autonome de projets et leadership transversal. Trs bonne connaissance des processus de dveloppement global, des normes rglementaires (GxP, GCP, ICH, ISO, MDR/IVDR), ainsi que des principes de GVP et dintgrit des donnes. Expertise confirme en documentation rglementaire clinique, scurit et/ou dispositifs mdicaux. Capacits solides danalyse, de synthse, de communication et de travail en matrices transversales. Matrise des outils G Suite, Microsoft Office, Adobe Acrobat et Veeva Vault. Anglais courant indispensable. Les avantages Astek Jusqu 4 semaines de congs plus 5 jours mobiles Rgime dassurance collectives avantageux incluant service de tlmdecine et programme daide aux employs (PAE) Remboursement du transport en commun Remboursement du forfait/tlphone cellulaire Remboursement des frais dadhsion un ordre professionnel (ex: OIQ) Allocation annuelle pour le sport/activits physiques Allocation annuelle pour matriel informatique Programme de cooptation incitatif Activits sociales (5@7, team buildings) Rencontrons-nous ! Vous vous tes reconnu sur lannonce et Astek vous plat ? Postulez directement sur cette annonce, afin que Justine , notre Spcialiste en Acquisition de Talents, puisse vous contacter pour un premier change. Julien , votre futur Manager, vous proposera ensuite dchanger autour de cette opportunit, de votre parcours et de vos attentes !