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Clinical Trials Regulatory Associate
Requisition ID: 7175171215
Janssen Pharmaceutical Companies of Johnson & Johnson, is currently hiring for a Clinical Trials Regulatory Associate to support our Global Clinical Operations team located in Toronto, Ontario.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women’s health. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.com/canada for more information.
As the Clinical Trial Regulatory Associate you will be responsible for the filing strategy and the end to end life cycle management of all clinical trials conducted by Global Clinical Operations Canada (GCOCA), covering all therapeutic areas (e.g. oncology, immunology, infectious disease cardio-vascular and metabolism). The scope is inclusive of a knowledge of small molecules (Health Canada Therapeutic Product Directorate/TPD) and large molecules (Health Canada Biologics Therapeutic Directorate / BGTD) requirements.
- Responsible for the trial filing strategy with a focus on timely planning, preparation, submission and approval of CTAs and tracking of associated regulatory documentation inclusive of local release of clinical supplies such that there is no impact to regulatory filing plans.
- Serve as the first and primary point of contact with Health Canada and works with the local study team and local and global Regulatory Affairs partners ensuring compliance with local laws, regulations, local and global standards, policies and procedures and no disruption to filing plans.
- Prepare and file Clinical Trial Applications (CTAs) inclusive of Quality Overall Summary / Investigational Medicinal Product Dossier (IMPD) and Protocol Safety and Efficacy Assessment Template (PSEAT), CTA-Amendments (CTA-As) and Notifications
- Assess protocol amendments and CMC updates to determine if they will be filed as CTA-Amendment or as a notification; process, track and communicate submission milestones (from Health Canada Acknowledgment of submission, No Objection Letter issuance, initiation of drug release, Clinical Trial Site Information (CTSI) Forms submission through to site and study closure)
- Lead interactions with Health Canada throughout the submission review cycle to ensure prompt regulatory approval; resolve submission issues and write/coordinate responses to Health Canada Clarifaxes
- Create release dossiers and perform technical assessment of certificates of analysis against product specifications in the Clinical Trial Application to ensure timely release of clinical drug supply
- Prepare for Health Canada pre-CTA consultations as requested (e.g., request meetings, coordinate the writing of the pre-meeting package, prepare and file the pre-meeting submission)
- Provide regulatory guidance and advise on clinical research in Canada as requested from local and global colleagues; be knowledgeable on Health Canada Regulations, Guidances and processes
- Provide training on regulatory requirements, process and systems to GCOCA clinical team
- Responsible for identifying new or revised country clinical trial application intelligence and assessment of impact on local operations / business including review of draft local regulations and local industry standards
- Provide input for and pilot the use of new internal and health authority regulatory systems as requested (e.g., CTAs in eCTD format)
- A minimum of a BSc. or equivalent health sciences degree
- A minimum of 3 years of pharmaceutical industry experience is required, with at least 3 years of clinical trial regulatory submission experience with a proficiency in the management of documents and clinical regulatory submissions to Health Canada
- Knowledge of several therapeutic areas is required
- Membership in one or more regulatory associations is an asset
- Comprehensive knowledge of Canadian Drug Laws, Health Canada Clinical Trial Regulations, Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP) / International Council for Harmonization (ICH) Guidelines
- Knowledge of pharmaceutical business processes and practices (e.g., SOPs governing clinical research activities) and a working knowledge of both Health Canada Directorates (TPD and BGTD)
- Excellent communication skills including communicating in challenging situations and in a matrix organization, across local and global functions
- Strong sense of urgency; ability to work in high pressure, high demand situations and balance concurrent deliverables
- Strong organizational, planning and prioritization skills
- Strategic thinker, manages complexity and leads key problem solving and decision making (i.e, lead submission strategy)Ability to influence; effectively lead projects/deliverables and direct people to achieve goals
- Team player; ability to work cross-functionally with different working styles and approaches
- Strong attention to detail; ability to interpret and summarize clinical data
- Proficient skill level in document management systems
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
Janssen Inc. (7710)