J&J Family of Companies
Apr 22, 2018
Janssen Pharmaceutical, a company of Johnson & Johnson is hiring a Senior Site Manager. This position is a field based role covering mainly Ontario; occasional travel outside of the province as needed. The preferred location is the Toronto area. 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.ca for more information. The Senior Site Manager will be part of the Global Clinical Operations (GCO) Canada group and will be responsible for site management through the assessment/selection, initiation, maintenance and closure phases of a clinical trial (Phase 1 – 4). + Primary contact for the site; liaison with study teams. + Proactively drive subject recruitment. + Monitor according to GCP standards and GCO SOPs (to include source document verification, Trial Centre File review and accurate drug accountability). + Responsible for resolution of site-specific issues and partnering with site to meet study milestones. + Work with in-house team to resolve protocol-specific issues. + Site training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial–specific tools and systems, and specialized procedures. + Maintain clinical trial tracking system (CTMS); update electronic Trial Master File (eTMF) as required. Qualifications + A minimum of a B.Sc., R.N., or equivalent degree is required, preferably in Biological Sciences. + A minimum of 3 years’ experience monitoring pharmaceutical industry clinical trials is required. + Knowledge of several therapeutic areas is an asset, oncology preferred. + Bilingualism (English & French) is an asset. + Ability to operate and proactively use various systems and databases (e.g. CTMS, eDC, eTMF, various dashboards/metrics, IWRS, safety reporting). + Analytical risk-based monitoring experience highly desirable. + Environment to establish a home office. + Willingness to travel up to 50% (up to 2-3 days per week) with overnight stays (up to 1-2 nights on average), is required. + Strong communication and influencing skills to effectively manage study sites both remotely and face to face. Team player, self-starter with ability to work independently + In-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. 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. Primary Location Canada-Ontario-Toronto Other Locations North America-Canada-Ontario Organization Janssen Inc. (7710) Job Function Clinical Trial Administration Requisition ID 7229171215
J&J Family of Companies Toronto, ON, M5R 1A6, CAN
Apr 22, 2018
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.ca for more information. Janssen Inc.is looking to hire a Senior Trade Operations Analyst to be based at head office in Toronto. Position Overview The Senior Trade Operations Analyst provides commercial oversight of Janssen products through our supply chain in Canada ultimately ensuring prescriptions can be filled at pharmacy. This encompasses Forecasting and tracking product demand, Customer Relationship management with wholesalers, partnering with internal business partners including Marketing, Customer Logistic Services (Customer Service, Warehouse & Transportation), Supply Chain and Finance. Responsibilities: + Develop and manage Wholesaler/Pharmacy relationships including business reviews, communication of relevant information, problem resolution/escalation, and contract management. + Leverage Customer/Wholesale data, provide analytics and reports to support forecasting, inventory changes, sales / rebates, pharmacy analysis, product launches, product diversion, inventory allocation, recalls, etc. + Provide market insights into the Marketing Sales Finance Forecast and S&OP consensus demand forecast for assigned brands. + Member of the new product launch teams, develop pipeline launch distribution strategies, list products with customers, ensure products are launched successfully and provide feedback on demand / other relevant information to the launch team along with recommendations. + Leverage Customer and industry relationships/knowledge to uncover market trends and insights to be used to create new innovative business solutions for Janssen and Customers (win/win opportunities for Customers and Janssen). + Collaborate with internal business partners across functions to establish mutually beneficial objectives, clear roles and accountabilities, creating a partnership environment around shared objectives to maximize outcomes for Janssen and our customers. Qualifications Qualifications: + University Degree required + Bilingual (English / French) is an asset but not required. + 5+ years of relevant experience. + Strong leadership, analytical, communication and collaboration / team building skills + Working knowledge of Supply Chain and Customer Relationship Management. + Some knowledge of Finance, Marketing, and Quality Competencies Required: + Highly analytical + Problem solving skills + Relationship management skills + Customer/marketplace focus + Business acumen and negotiation skills + Ability to master ambiguity and complexity + Ability to build consensus and impact outcomes, with limited authority 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 an opportunity to achieve their potential. Primary Location Canada-Ontario-Toronto Organization Janssen Inc. (7710) Job Function Trade Relations Requisition ID 8649180411
J&J Family of Companies Toronto, ON, M5R 1A6, CAN
Apr 22, 2018
Janssen Pharmaceutical, une entreprise de Johnson & Johnson, est à la recherche d’un chef des essais cliniques locaux. L’endroit privilégié pour ce poste est Toronto (Ontario), mais il pourrait être possible de travailler à distance ailleurs au Canada. Chez Janssen, nous nous employons à répondre à certains des besoins médicaux non satisfaits les plus importants de notre époque dans les domaines de l’hématologie, de l’oncologie, de l’immunologie, des neurosciences, des maladies infectieuses et des vaccins, des maladies métaboliques et chroniques et de la santé de la femme. Motivés par notre engagement envers les patients, nous offrons des produits, des solutions et des services novateurs dans le monde entier. Janssen Inc. est membre du groupe Janssen Pharmaceutical Companies of Johnson & Johnson. Veuillez visiter le site www.janssen.ca pour obtenir de plus amples renseignements. Responsabilités : + Assurer la gestion globale de projets du volet canadien des études d’homologation multicentriques internationales ou des études menées par les Affaires médicales (phase I à IV). + Diriger l’équipe responsable des études locales (p. ex. chefs ou surveillants de site régional, spécialistes des documents, soutien administratif). + Être responsable, envers l’équipe des études mondiales, de la coordination des essais et des livrables des études. + Diriger l’équipe responsable des études locales. Assurer la faisabilité locale et la sélection des investigateurs. Être responsable des activités de démarrage des études, du recrutement des sujets et des plans d’urgence à l’échelle nationale ainsi que des rapports d’innocuité, de l’acquisition opportune de données de qualité et de la documentation des essais; gérer les dépenses et les prévisions relatives aux études. + Assurer la tenue d’un dossier maître complet des essais cliniques (documents essentiels relatifs aux essais) tout au long de la progression des essais cliniques. + Vérifier et inspecter les préparatifs. + Contribuer au développement et à l’optimisation des procédures et processus des services dans le cadre des efforts de l’entreprise visant l’amélioration continue de la qualité. Qualifications + Baccalauréat en sciences, titre d’infirmière autorisée, maîtrise ès sciences ou diplôme équivalent en sciences biologiques. + Au moins trois ans d’expérience en recherche clinique, y compris en gestion de centres dans le cadre d’essais (de phase II à III au minimum). + Expérience dans la gestion globale d’essais et la gestion d’essais fondée sur les risques, un atout. + Connaissance approfondie des lignes directrices de la CIH, des bonnes pratiques cliniques ainsi que de la réglementation canadienne. + Solides compétences en gestion de projets, avec souci des livrables des études, de la qualité et des délais correspondants, et surveillance des essais/centres. + Connaissance de plusieurs secteurs thérapeutiques, un atout. + Compétences démontrées dans les domaines suivants : leadership, jugement, communication, souci du détail, résolution proactive de problèmes, analyse, négociation, et innovation. + Aptitudes solides pour l’établissement de priorités, la prise de décision et l’adaptation. Capacité à gérer des situations complexes et à respecter les délais. Souplesse et capacité à s’adapter et à travailler efficacement dans un environnement évolutif. + Expérience et compétence élevée dans le classement de documents électroniques, les systèmes de données et la production de rapports. La diversité et l’intégration sont des éléments centraux de la culture que nous partageons au sein du Groupe des entreprises Johnson & Johnson. Trois aspects importants sont essentiels à notre réussite : le recrutement, le perfectionnement, et la fidélisation d’un personnel qui reflète la diversité de notre clientèle et des communautés dans lesquelles nous œuvrons. Nous avons à cœur d’offrir un environnement de travail respectueux, accueillant et accessible dans lequel tous les employés peuvent s’épanouir. Emplacement principal Canada-Ontario-Toronto Autres emplacements North America-Canada Organisation Janssen Inc. (7710) Fonction Clinical Trial Administration Requisition ID 7163171215
J&J Family of Companies Toronto, ON, M5R 1A6, CAN
Apr 22, 2018
Janssen Pharmaceutical Companies of Johnson & Johnson est actuellement à la recherche d’un chef de projets, affaires cliniques/chef des essais cliniques locaux. L’endroit privilégié pour ce poste est Toronto (Ontario), mais il pourrait être possible de travailler à distance ailleurs au Canada. Chez Janssen, nous nous employons à répondre à certains des besoins médicaux non satisfaits les plus importants dans les domaines de l’oncologie, de l’immunologie, des neurosciences, des maladies infectieuses et des vaccins, des troubles métaboliques, des maladies chroniques et de la santé des femmes. Motivés par notre engagement envers les patients, nous offrons des produits, des solutions et des services novateurs dans le monde entier. Janssen Inc. est membre du groupe Janssen Pharmaceutical Companies of Johnson & Johnson. Veuillez visiter le site www.janssen.com/canada/fr pour de plus amples renseignements. Responsabilités : + Assurer la gestion globale de projets du volet canadien des études d’homologation multicentriques internationales ou des études menées par les Affaires médicales (phase I à IV). + Être responsable envers les équipes des études mondiales de la coordination des essais et des livrables des études. + Diriger l’équipe responsable des études locales (p. ex., chefs ou surveillants de site régional, spécialistes des documents, soutien administratif). + Assurer la faisabilité locale et la sélection des investigateurs, les activités de démarrage des études, le recrutement des sujets et les plans d’urgence à l’échelle nationale ainsi que les rapports d’innocuité, l’acquisition opportune de données de qualité et la documentation des essais; gérer les dépenses et les prévisions relatives aux études. + Tenir à jour un dossier maître complet des essais cliniques (documents essentiels relatifs aux essais) tout au long de la progression des essais cliniques. + Vérifier et inspecter les préparatifs. + Contribuer au développement et à l’optimisation des procédures et processus des services dans le cadre des efforts de l’entreprise visant l’amélioration continue de la qualité. + Le candidat retenu peut devoir se déplacer jusqu’à 10 % du temps (au Canada et à l’étranger). Qualifications + Baccalauréat ou diplôme de niveau supérieur en sciences biologiques ou titre d’infirmière ou d’infirmier autorisé(e). + Au moins trois ans d’expérience en recherche clinique, y compris en gestion d’essais et en gestion de projets dans le cadre d’essais cliniques (de phase II à III au minimum). + Expérience dans la gestion d’essais fondée sur les risques, un atout. + Connaissance de plusieurs secteurs thérapeutiques, un atout. + Connaissance approfondie des lignes directrices de la conférence internationale d’harmonisation, des bonnes pratiques cliniques ainsi que de la réglementation canadienne. + Solides compétences en gestion de projets, avec souci et contrôle des livrables des études, de la qualité et des délais correspondants. + Capacité à gérer les aspects complexes; souplesse et capacité à s’adapter et de travailler efficacement dans un environnement évolutif. + Excellentes aptitudes en communication orale et écrite, notamment en présentation. La maîtrise du français (tant à l’oral qu’à l’écrit), un atout. + Expérience et compétence élevée dans le classement de documents électroniques, les systèmes de données et la production de rapports. + Grand souci du détail et de la qualité des résultats. + Aptitudes démontrées pour la collaboration mutuelle et stratégique. + Aptitudes en collaboration et en résolution de conflit. + Solides compétences dans les domaines suivants : jugement, résolution de problèmes, leadership, analyse, négociation et innovation. + Capacité à travailler de façon autonome. La diversité et l’intégration sont des éléments centraux de la culture que nous partageons au sein du Groupe des entreprises Johnson & Johnson. Trois aspects importants sont essentiels à notre réussite : le recrutement, le perfectionnement, et la fidélisation d’un personnel qui représente la diversité de notre clientèle et des communautés dans lesquelles nous œuvrons. Nous avons à cœur d’offrir un environnement de travail respectueux, accueillant et accessible dans lequel tous les employés peuvent s’épanouir. Emplacement principal Canada-Ontario-Toronto Autres emplacements North America-Canada Organisation Janssen Inc. (7710) Fonction Clinical Trial Administration Requisition ID 7739180330
J&J Family of Companies Toronto, ON, M5R 1A6, CAN
Apr 22, 2018
Janssen Pharmaceutical, Companies of Johnson & Johnson is currently hiring a National, Medical Education Manager located in Toronto, ON. About Janssen Inc. 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.ca for more information. Position Overview In this Head Office based role, you will lead a team of Regional Medical Education Managers (MEM’s) to develop and execute a National Medical Education Strategy and tactical plan for the Immunology IBD portfolio. Resulting in the improvement of health care professional learning metrics in knowledge, attitude and skill for current patient adherence, new treatment optimization and competitive differentiation. As a key member of the Business Implementation Team (BIM) and the Medical Education Team, you will actively participate in strategic planning and ongoing tactical management of the business and lead department initiatives. Your core responsibilities: + Lead the development and ongoing execution of the National and Regional Medical Education and digital communication plans supporting the Immunology IBD business. + Manage and implement in-field medical education activities and KOL development within Gastroenterology + Provide management oversight to the MEM team as they develop and execute their plans in support of our regional efforts as a primary focus, and provide leadership as they partake in supporting national programs + Attract, develop, recognize and retain an industry leading team of IBD MEMs + Embed themselves into the cross functional teams (BIMs, Access, government and stakeholder relations teams) supporting IBD + Through Customer Insight Research and CHE program metrics, provide strategic direction for existing and emerging customer plans, conferences, symposia etc. + Medical Education budget and vendor management for IBD + Stay abreast of emerging data and translate the data into applicable tactics for knowledge transfer to health care professionals + Lead Medical Education franchise and Medical Affairs department projects Qualifications + A minimum of a university degree is required preferably in Business, Life Sciences or related Health Sciences discipline; a MBA is an asset + A minimum of 5 years of professional business experience is required + Prior experience working within Gastroenterology / Immunology product Sales, Marketing and/or Medical Education is highly desirable + Therapeutic area and customer knowledge in one or more areas (Dermatology, Rheumatology and IBD) and experience supporting a biologic product is an asset + Demonstration of coaching competencies and ability to lead people; previous experience in leadership roles is highly desirable + Solid knowledge of the IMC code, Healthcare Compliance policies and procedures and the principles of adult learning is required + Results driven, assertive, strategic thinker, strong project and account management skills are preferred + Demonstrated ability to work closely with Key Opinion Leaders to gain key marketing insights and to develop CHE content + Bilingual: French/English an asset + Willing and able to travel (domestic and international) approximately 40% of the time 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. Primary Location Canada-Ontario-Toronto Organization Janssen Inc. (7710) Job Function Medical Science Liaison Requisition ID 4196180223
J&J Family of Companies Toronto, ON, M5R 1A6, CAN
Apr 22, 2018
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products. Packaging Operators contribute to the team while operating solid and liquid dosage packaging equipment. This function also includes line set up and assembly, operating material handling equipment, cleaning and sanitation of all related equipment and work areas. Packaging Operators are committed to continuous quality improvement involving the identification and implementation of process improvements. The individual will be required to monitor equipment functions, troubleshoot and correct minor equipment issues. Responsibilities: • Ensure quality and compliance in all my actions by: – Attending GMP training – Adhere to strict compliance with procedures – Exercise the highest level of integrity in the tasks that I perform – Involvement and dedication to doing the job right the first time Safety • Wears all protective equipment • Instructs others in safe operation of equipment as required • Understands and adheres to all health and safety aspects and S.O.P.’s • Identifies and reports unsafe conditions / near misses • Successful completion of WHIMIS, Safety Orientation, and Safe Start • Ensures that equipment is in safe operating condition • Understands the ability to utilize the incident database. Timely determination of corrective action Principle Responsibilities • Perform appropriate levels of cleanliness and housekeeping standards as outlined, consistent with the requirements for Good Manufacturing Practices • Maintains equipment and tools in a clean and safe operating condition • Reads the production schedule and collects input from operators to understand goods movements, material requirements and key tasks for the shifts • Stage totes and materials as required • Manages cleaning requirements for common areas, including packaging storage rooms and clean up rooms • Monitor and record all necessary packaging and cleaning/sanitation documentation • Has a sound understanding of GMPs and GDPs • Able to troubleshoot SAP discrepancies and adjust accordingly • Maintains an updated and current training record and adheres to training timelines • Functions in compliance with all GMP’s, safety requirements and applicable standard operating procedures • Participates, with leadership, in team and department meetings. Daily shift communications and communications with Supervisor, Manager • Performs other related or assigned duties as required in all assigned areas • Responsible for working with Supervisor for yearly, O.G.S.M., performance review and conflict resolution Documentation • Experience with SAP • Strong computer literacy Team Building • Ability to collaborate and work effectively in a team environment with limited supervision Leadership • Identifies opportunities for improvement • Exhibits a mature attitude to promote an atmosphere of good communications and collaboration within the department Sanitation • Responsible for work area and equipment cleanliness and compliance to the standard operating procedure Communication • Ability to communicate with packaging employees both within across shifts (Resource requirements, escalation of issues, clear and concise handover) Miscellaneous • Occasionally will be required to work overtime to achieving packaging targets Qualifications Education: • High School Diploma or GED equivalency Experience: • 2-4 years of Packaging Operator experience in a regulated environment Physical Demands: • Ability to lift up to 50lbs and maneuvering of equipment BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. 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. Primary Location Canada-Ontario-Guelph Organization Johnson & Johnson Inc. (7695) Job Function Production Requisition ID 7311180327
J&J Family of Companies Guelph, ON, N1H 3H3, CAN
Apr 22, 2018
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products. The Senior Financial Analyst, under minimal supervision, is responsible for guiding balanced financial decisions related to the performance of the site. This position will report to the Plant Controller, Guelph Site. The individual will be responsible for business partnering across departments. S/he will support capital investment decisions, inventory analysis, hedging analysis and headcount analysis. This is a critical and high visibility role within the Site and provides significant opportunities to present to management. Major Duties and responsibilities: - Supports Engineering Lead in developing the Capital Strategy for the site and supporting operations teams in developing business cases for capital requests. - Responsible for maintaining the Capital SOP for the Guelph Site and ensure that capital requests are being performed in compliance with SOP. Works with the Fixed Asset Centre Of Excellence (COE) to ensure accounting transactions are being performed appropriately by COE. - Responsible for the development of the annual business plan and major forecast updates for Capital, Depreciation and Appropriation Expense across the entire site. Helping determine which capital should be invested in and what impacts this will have to the P&L - Responsible for partnering with the planning organization to analyze inventory levels, as well as reporting inventory quarterly and overseeing the cycle count process managed by operations team. - Responsible for working with other affiliates on intercompany charges from and to the Guelph Site. - Responsible for determining, reporting and forecasting affiliate sales, costs and gross profit. Quarterly will book profit elimination entries to ensure appropriate intercompany accounting & proper consolidation of J&J results. - Responsible for managing hedging forecasts and analysis with treasury department - Responsible for working with COE on developing Headcount forecasts and reporting budget and actuals and explaining variances between plan and actuals - Responsible for monthly cash deposits - Ad hoc responsibilities as assigned Qualifications University/Bachelor's degree (Finance and or Accounting) is a requirement A CPA designation is a requirement (CMA, CPA/CGA, CPA/CA, CPA) A minimum of 5-6 years in Finance operations. Prior financial role/experience in financial planning & analysis and or Supply Chain plant environment is preferred. Knowledge, Skills and Abilities ; - Process driven individual who is able to excel in a fast-paced environment - Proven track record collaborating/influencing across functions - Demonstrates strong analytical, negotiation and problem-solving skills. - Excellent oral and written communication skills (in English) - Knowledge in computerized ERP systems (SAP experience preferred) & FP&A systems (Cognos is preferred) BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. 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. Primary Location Canada-Ontario-Guelph Organization Johnson & Johnson Inc. (7695) Job Function Planning & Analysis Requisition ID 2680171016
J&J Family of Companies Guelph, ON, N1H 3H3, CAN
Apr 22, 2018
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products. Processing Operators contribute to the McNeil team by being involved in all aspects of processing bulk pharmaceutical products in a regulated manufacturing environment. Responsibilities include: • Dispensing of raw materials, set-up and operation of a fluid-bed granulator, tablet presses, film coating equipment and other processing and test equipment • Monitor and record all processing parameters and maintain all necessary processing and sanitation documentation • Assist the packaging department to operate the solid and liquid dosage packaging equipment Qualifications Education and Experience: • Previous pharmaceutical processing experience is an asset • Completion of Science degree (chemistry, biology, biochemistry, etc.) is an asset • Ability to be trained in the use of pallet trucks and walking stackers for moving quantities of bulk tablets and raw materials • Mechanical aptitude is essential; previous mechanical experience or training highly preferred Competencies: • Proficiency in MS Word, Excel, and SAP are required • Strong mechanical aptitude is required – use of tools and troubleshooting machinery to implement effective solutions • Ability to lift 50lbs regularly • Excellent attention to detail in documentation and execution of all Standard Operating Procedures • Superior time management and problem solving skills • The ability to function and collaborate effectively in a team environment • Quality and continuous process improvement focused BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. 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. Primary Location Canada-Ontario-Guelph Organization Johnson & Johnson Inc. (7695) Job Function Production Requisition ID 7830180402
J&J Family of Companies Guelph, ON, N1H 3H3, CAN
Apr 22, 2018
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products. As a member of the Plant Quality team, the Quality Specialist I will support all aspects of compliance related activities at the facility. The Quality Specialist I is responsible for ensuring that McNeil Consumer Healthcare Company operates in compliance with Johnson and Johnson Corporate policies, internal requirements, and Regulatory requirements. This role will support Quality & Compliance with a broad base of experience and expertise. This is a 12 month contract, Afternoon Shift, opportunity. Responsibilities: • Review internal batch records and release product for sale in SAP • Collaborate with and act as the primary contact for internal manufacturing and packaging to assist in troubleshooting, and problem-solving quality issues • Identify and drive the implementation of innovative approaches to continuously improve current systems and processes • Represent Quality & Compliance on task forces/committees/process improvement projects • Perform quality audits of production activities, including but not limited to Line Clearance checks and GEMBA walks • Provide approval of offline rework/inspection activities • Provide training on quality topics to Plant Operations personnel • Comply with J&J policies, quality/technical standards, health, safety, and environmental regulations, and regulatory requirements (Health Canada, United States FDA etc.) Qualifications Education and Experience Requirements: • Minimum of Bachelor’s Degree in Life Sciences (e.g. Biology, Chemistry, Biochemistry or related) • Minimum of 2-3 years’ experience within the chemical/food/pharmaceutical industry or Quality environment • Good knowledge of GMP regulations • Strong computer skills Competencies: • Ability to work with limited supervision and function effectively in a team environment is required • Good interpersonal and collaboration skills • Excellent communication skills, and attention to detail • Demonstrated ability to organize, multitask and prioritize workload • Demonstrated problem solving capabilities • Excellent decision-making skills • Familiarity with computer software and strong personal computer skills • Enjoys working to multiple deadlines in a dynamic and fast-paced team environment BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. 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. Primary Location Canada-Ontario-Guelph Organization Johnson & Johnson Inc. (7695) Job Function Quality Assurance Requisition ID 8600180410
J&J Family of Companies Guelph, ON, N1H 3H3, CAN
Apr 22, 2018
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products. As a member of the Plant Quality team, the Quality Specialist I will support all aspects of compliance related activities at the facility. The Quality Specialist I is responsible for ensuring that McNeil Consumer Healthcare Company operates in compliance with Johnson and Johnson Corporate policies, internal requirements, and Regulatory requirements. This role will support Quality & Compliance with a broad base of experience and expertise. This is a NIGHT shift, 12 month contract opportunity. Responsibilities: • Review internal batch records and release product for sale in SAP • Collaborate with and act as the primary contact for internal manufacturing and packaging to assist in troubleshooting, and problem-solving quality issues • Identify and drive the implementation of innovative approaches to continuously improve current systems and processes • Represent Quality & Compliance on task forces/committees/process improvement projects • Perform quality audits of production activities, including but not limited to Line Clearance checks and GEMBA walks • Provide approval of offline rework/inspection activities • Provide training on quality topics to Plant Operations personnel • Comply with J&J policies, quality/technical standards, health, safety, and environmental regulations, and regulatory requirements (Health Canada, United States FDA etc.) Qualifications Education and Experience Requirements: • Minimum of Bachelor’s Degree in Life Sciences (e.g. Biology, Chemistry, Biochemistry or related) • Minimum of 2-3 years’ experience within the chemical/food/pharmaceutical industry or Quality environment • Good knowledge of GMP regulations • Strong computer skills Competencies: • Ability to work with limited supervision and function effectively in a team environment is required • Good interpersonal and collaboration skills • Excellent communication skills, and attention to detail • Demonstrated ability to organize, multitask and prioritize workload • Demonstrated problem solving capabilities • Excellent decision-making skills • Familiarity with computer software and strong personal computer skills • Enjoys working to multiple deadlines in a dynamic and fast-paced team environment BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. 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. Primary Location Canada-Ontario-Guelph Organization Johnson & Johnson Inc. (7695) Job Function Quality Assurance Requisition ID 8626180410
J&J Family of Companies Guelph, ON, N1H 3H3, CAN
Apr 22, 2018
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products. The Principal Scientist - Tech Ops Validation provides leadership and oversight for process, package and cleaning validation in support of the manufacture of OTC medicinal drug products for Guelph. This individual will be responsible to coordinate, provide oversight and author documents that supports the validation processes for Global Technical Operations (GTO) and is responsible for the execution of specific tactical elements in support of the validation objectives. Partners, consults, crafts and influences validation principles with GTO, manufacturing and quality management. Responsible to establish and maintain strong and effective collaborations with internal business partners. This role may include leading a team of junior professionals and managing their performance in conjunction with the Manager or Director. Responsibilities: • Independently leads and provides oversight to the design and execution of process, package and cleaning validation for OTC products. Responsible for gaining alignment on strategy with cross functional leaders • Author GMP/GDP compliant technical documents including validation strategy, protocols and reports supporting the OTC business. • Responsible for coordinating document requirements with cross functional partners at the local, regional and global level to ensure consistency and alignment with global policies and procedures • Acts as the GTO Subject Matter Expert for process, package and cleaning validation for the Guelph manufacturing plant • Manage communication across the Guelph manufacturing plant on validation/qualification status • Lead validation projects to support alignment with applicable federal agencies and/or regulatory bodies • Engages in project and program management; identifies and implements process level efficiencies • Makes progression towards creative thinking at the macro level • This role may include the management of a small team of junior professionals including performance management under mentorship from the Manager/Director • Ensures compliance with GMP/GLP regulations, regulatory agency regulations and interpretations • Identifying, reporting, and seeking correction for deviations • Attending GMP training Qualifications Education: Bachelors degree with engineering, chemistry, scientific or pharmaceutics background, or equivalent industry experience. Experience: Minimum of 8 years’ experience within the pharmaceutical or related industry. Knowledge, Skills and Abilities: • Solid experience in validation and project management with strong knowledge of GMPs, GLPs, SOPs and regulatory trends • Ability to write effective technical documents • Ability to independently lead, plan, organize, coordinate and manage assigned tasks, individually and cross functionally • Demonstrated collaboration, organizational and influencing skills • Demonstrated leadership skills to align and influence team members/leaders on strategy and approach • Deep knowledge of scientific theories and principles in a specialized technical field • Excellent oral and written communication skills • Technical experience/knowledge in the pharmaceutical manufacturing industry is preferred • Applies organizational understanding and awareness and participates in decision-making in collaboration with others Working Conditions • Controlled exposure to dust, fumes and noise • Occasional requirement to work on an off-shift to support project requirements • Use of some Personal Protective Equipment may be required • Occasional travel to international affiliates, supplier and contractors BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. 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. Primary Location Canada-Ontario-Guelph Organization Johnson & Johnson Inc. (7695) Job Function Validation Requisition ID 6347180323
J&J Family of Companies Guelph, ON, N1H 3H3, CAN
Apr 22, 2018
Janssen Inc. is looking to hire a Territory Manager to join our Partners in Psychiatry team (calling primarily on Psychiatrists and Pediatricians) in Hamilton and Brantford Ontario. As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen Inc. is dedicated to addressing and solving the most important unmet medical needs in pain management, psychiatry, oncology, psoriasis, virology, anemia, attention deficit hyperactivity disorder, dementia, rheumatology, gastroenterology and women’s health. Driven by our commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world. Please visit www.janssen.ca for more information. In this role, the incumbent's responsibilities include but are not limited to: + Achieve sales targets and business objectives for assigned brands/indications through customer interactions via 1:1 selling and CHE/OGA activity within designated territory. + Develop and execute against a formalized territory business plan which outlines customer-centric strategies to yield measurable returns. Achieve superior results through business analytics, insight-driven solutions, and an understanding of key drivers of performance. + Plan and develop specific hospital- and community- based initiatives in collaboration with business partners in Sales, Marketing, and Medical Affairs. + Become an acknowledged expert in the business with in-depth product and clinical knowledge and a deep understanding the healthcare environment (including customers, products, regulatory environment, and competitive set). + Develop and implement innovative, value-creating solutions that improve business outcomes. Focuses on results-oriented activities to optimize time, efficiency, and impact. + Build purposeful internal and external networks to develop and drive collaborative value-added solutions. Qualifications + A minimum of a University degree is required, preferably in Lifesciences or Business. + 3+ years proven track record of success in direct selling or marketing experience is required, preferably in the pharmaceutical industry. + Ability to thrive in an independent work environment, self-directed and motivated while also demonstrating the ability to work effectively in a matrix project team environment. + Specialty Sales experience in a competitive selling environment is an asset. + Experience in the Psychiatry or Pediatrics market is an asset. + Demonstrated strength with building relationships, business partnering, and leading amongst peers. + Demonstrated ability (with supportive examples) in business planning skills including: customer engagement, critical thinking, problem solving, and entrepreneurial mindset. + Excellent verbal and written communication skills, including discussions of highly technical concepts. + Strong business acumen, strategic business orientation, and an understanding of customer segmentation models. + Proficiency in Microsoft applications and comfortable learning new technology platforms. + Must have a valid driver’s license and meet J&J fleet safety requirements. 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. Primary Location Canada-Ontario-Hamilton Other Locations North America-Canada-Ontario-Brantford Organization Janssen Inc. (7710) Job Function Selling Pharmaceutical Requisition ID 3916180221
J&J Family of Companies Brantford, ON, N3R 3V3, CAN
Apr 22, 2018
LifeScan Canada Ltd. is currently recruiting for a Territory Manager to join our team to provide support to pharmacy and medical accounts located in the London area. LifeScan Canada Ltd. is committed to improving the quality of life for people with diabetes. It is our focus to create unique products that are tailored to meet the needs of people with diabetes and their health care providers. To date our inventive spirit has led to reliable, portable and easy-to-use blood glucose monitors. As a leader in blood glucose monitoring, LifeScan is working to bring you the next important advances in diabetes care. Our employees are guided by the Johnson & Johnson Credo, a statement of values that reinforces LifeScan's commitment to its customers, their families and the highest quality standards. This is a 12-month renewable contract role. The candidate will be responsible for managing a territory with duties that focus on building recommendations for OneTouch products. The primary responsibilities of this position include: + Call on healthcare professionals in the medical & pharmacy channels to help educate them on the value of the OneTouch portfolio of products. + Responsible for forming strong relationships that will help increase product recommendations with pharmacists, physicians and certified diabetes educators. + Conducts training and promotional events (i.e. CHE/CME, Clinic Days, Lunch & Learns etc.) to enhance the education of customers. + Execute POA direction to meet and exceed company forecast. + Create, update & drive territory business plans by uncovering opportunities that will help develop our business + Leveraging analytical data to determine best course of action. + Utilize territory budget to secure incremental merchandising activity and execute pharmacy programs. + Achieve assigned sales goals as established by the Regional Business Manager and/or senior staff. + Develop and execute HCP & patient educational events across territory. Qualifications + A minimum of a University degree is required, preferably in Business, Health Science, Business Administration or Commerce. + A minimum of 2 years direct sales or Business to Business experience is required, medical device sales experience is preferred. + Strong business knowledge and negotiation skills. + Diabetes knowledge is an asset. + Clean driving record. + This position is located in London and requires travel of up to 40% of the time. 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. Primary Location Canada-Ontario-London Organization Johnson & Johnson Inc. (7695) Job Function Selling MD&D Requisition ID 7349180328
J&J Family of Companies London, ON, N6A 1B1, CAN
Apr 22, 2018
Janssen Inc. is looking to hire a Territory Manager to join our Partners in Psychiatry team (calling primarily on Psychiatrists and Pediatricians) in Hamilton and Brantford Ontario. As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen Inc. is dedicated to addressing and solving the most important unmet medical needs in pain management, psychiatry, oncology, psoriasis, virology, anemia, attention deficit hyperactivity disorder, dementia, rheumatology, gastroenterology and women’s health. Driven by our commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world. Please visit www.janssen.ca for more information. In this role, the incumbent's responsibilities include but are not limited to: + Achieve sales targets and business objectives for assigned brands/indications through customer interactions via 1:1 selling and CHE/OGA activity within designated territory. + Develop and execute against a formalized territory business plan which outlines customer-centric strategies to yield measurable returns. Achieve superior results through business analytics, insight-driven solutions, and an understanding of key drivers of performance. + Plan and develop specific hospital- and community- based initiatives in collaboration with business partners in Sales, Marketing, and Medical Affairs. + Become an acknowledged expert in the business with in-depth product and clinical knowledge and a deep understanding the healthcare environment (including customers, products, regulatory environment, and competitive set). + Develop and implement innovative, value-creating solutions that improve business outcomes. Focuses on results-oriented activities to optimize time, efficiency, and impact. + Build purposeful internal and external networks to develop and drive collaborative value-added solutions. Qualifications + A minimum of a University degree is required, preferably in Lifesciences or Business. + 3+ years proven track record of success in direct selling or marketing experience is required, preferably in the pharmaceutical industry. + Ability to thrive in an independent work environment, self-directed and motivated while also demonstrating the ability to work effectively in a matrix project team environment. + Specialty Sales experience in a competitive selling environment is an asset. + Experience in the Psychiatry or Pediatrics market is an asset. + Demonstrated strength with building relationships, business partnering, and leading amongst peers. + Demonstrated ability (with supportive examples) in business planning skills including: customer engagement, critical thinking, problem solving, and entrepreneurial mindset. + Excellent verbal and written communication skills, including discussions of highly technical concepts. + Strong business acumen, strategic business orientation, and an understanding of customer segmentation models. + Proficiency in Microsoft applications and comfortable learning new technology platforms. + Must have a valid driver’s license and meet J&J fleet safety requirements. 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. Primary Location Canada-Ontario-Hamilton Other Locations North America-Canada-Ontario-Brantford Organization Janssen Inc. (7710) Job Function Selling Pharmaceutical Requisition ID 3916180221
J&J Family of Companies Hamilton, ON, L8V 1G6, CAN
Apr 22, 2018
Janssen Pharmaceutical Companies of Johnson & Johnson, is currently hiring for a Clinical Project Manager / Local Trial Manager. The preferred location is Toronto, ON, with consideration for a remote location in Canada. 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. Responsibilities: + Overall project management of the Canadian component of multicentre, international registration studies and/or Medical Affairs studies (Phases 1-4) + Accountable to Global study teams for trial coordination and study deliverables for trial coordination and study deliverables + Provide leadership to the local study team (e.g. Regional Site Managers/Monitors, document specialists, admin support) + Responsible for local feasibility and investigator selection, study start-up activities, subject recruitment and contingency plans at the country level, safety reporting, timely acquisition of quality data and trial documentation; study spend and forecast management + Ensure complete Trial Master File (essential trial documents) to parallel the progress of the clinical trial. + Audit and inspection preparation + Contribute to the development and improvement of departmental procedures and processes in the scope of the company’s effort towards continuous quality improvement. + This position may require up to 10% domestic and international travel. Qualifications + A minimum of a Bachelor’s degree or RN in Biological Sciences is required. + Minimum of three years in Clinical Research including trial management and project management experience in clinical trials (phases 2 and 3 at minimum). + Experience with risk based trial management is an asset. + Knowledge of several therapeutic areas is as asset + In-depth knowledge of ICH-GCP and Canadian regulations + Strong project management skills with focus on study deliverables, oversight, quality and timelines + Ability to manage complexity; flexible and able to work well in a changing environment + Excellent oral and written communication skills including strong presentation skills. French (written and oral) is an asset + Experience and high proficiency with electronic filing, data systems and reporting + Strong attention to detail and focus on quality results + Proven interdependent and strategic partnering ability + Collaboration and conflict resolution skills. + Solid skills in the areas of judgement, problem-solving, leadership, analysis, negotiation, and innovation + Ability to work independently 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. Primary Location Canada-Ontario-Toronto Other Locations North America-Canada Organization Janssen Inc. (7710) Job Function Clinical Trial Administration Requisition ID 7739180330
J&J Family of Companies Toronto, ON, M5R 1A6, CAN
Apr 22, 2018
Janssen Inc., member of the Janssen Pharmaceutical Companies of Johnson & Johnson, is currently hiring for a Regulatory Affairs Manager 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. The Regulatory Affairs Manager will lead the regulatory activities to obtain and maintain product registration status in compliance with Canadian laws and regulations, as well as corporate policies and procedures. The Regulatory Affairs Manager will lead and support product registration and serve as the subject matter expert for Regulatory Affairs and provide guidance to local and global business partners. The Manager will develop and implement regulatory strategies to meet project deliverables. + Lead the preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), Notifiable Changes (NCs), and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products (the primary focus of this role is clinical/therapeutic not CMC). + Lead the preparation and review of responses to Health Canada queries in relation to clinical efficacy and safety, clinical pharmacology, biopharmaceutics and preclinical subject matter (e.g. Clarifax, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]) in a timely manner. + Lead interactions with Health Canada throughout the submission review cycle to ensure prompt regulatory approval, optimal labeling and implementation of local regulatory strategies. + Collaborate with global regulatory teams and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities. + Collaborate with internal stakeholders to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and stretch goals/deadlines set out by the leadership team. + Develop effective working relationships with experts to support regulatory strategies as needed. + Manage emerging issues (e.g. new safety or quality finding) and associated risk communications to stakeholders. + Provide regulatory guidance and input to internal stakeholders on messaging, promotional material review, and PAAB responses. + Monitor the regulatory environment, interpret changes, analyze gaps and conduct impact assessment, and participate/lead implementation into systems/processes. + Actively contribute to improving critical departmental processes and to initiatives to enhance the internal work environment. Qualifications + A minimum B.Sc. in Biological or related sciences. Advanced degree preferred. + A minimum of 3 years of Regulatory Affairs pharmaceutical or related experience is required. + Experienced with preparation and compilation of New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), Notifiable Changes (NCs) for Health Canada is required. + Experience in the oncology therapeutic area is highly desirable. + Strong working knowledge of the drug development process is required. + Strong knowledge of Canadian drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions is required. + Understanding of the application of laws, regulations, guidances and policies to specific projects. + Ability to interpret and understand Regulations in the context of the scientific and commercial environment. + Strong scientific writing skills are required. + Ability to interpret and summarize clinical data. + Ability to interpret basic biostatistics highly desirable 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. Primary Location Canada-Ontario-Toronto Organization Janssen Inc. (7710) Job Function Regulatory Affairs Requisition ID 2607171026
J&J Family of Companies Toronto, ON, M5R 1A6, CAN
Apr 22, 2018
Janssen Pharmaceutical, a company of Johnson & Johnson is hiring a Local Trial Manager. The preferred location is Toronto, ON, with consideration for a remote location in Canada. At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in hematology, 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.ca for more information. Responsibilities: + Overall project management of the Canadian component of multicentre, international registration studies and/or Medical Affairs studies (Phases 1-4) + Provide leadership to the local study team (e.g. Regional Site Managers/Monitors, document specialists, admin support) + Accountable to Global study team for trial coordination and study deliverables + Leadership of local study team. Contributions to local feasibility and investigator selection. Responsible for study start-up activities, subject recruitment and contingency plans at the country level, safety reporting, timely acquisition of quality data and trial documentation; study spend and forecast management + Ensure complete Trial Master File (essential trial documents) to parallel the progress of the clinical trial. + Audit and inspection readiness + Contribute to the development and improvement of departmental procedures and processes in the scope of the company’s effort towards continuous quality improvement. + This position may require up to 10% domestic and international travel. Qualifications + BSc, RN or MSc or equivalent degree in Biological Sciences + Minimum of three years in Clinical Research including site management experience in clinical trials (phases 2 and 3 at minimum). + Experience with overall trial management and risk based trial management is an asset. + In-depth knowledge of ICH-GCP and Canadian regulations + Strong project management skills with focus on study deliverables, trial/site oversight, quality and timelines + Knowledge of several therapeutic areas is an asset + Demonstrated skills in leadership and in the areas of judgement, communication, attention to detail, proactive problem-solving, analysis, negotiation, and innovation. + Strong prioritization, decision-making and adaptability skills. Ability to manage complexity and meet deadlines. Strategic, flexible and able to work well in a changing environment + Experience and high proficiency with electronic filing, data systems and reporting 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. Primary Location Canada-Ontario-Toronto Other Locations North America-Canada Organization Janssen Inc. (7710) Job Function Clinical Trial Administration Requisition ID 7163171215
J&J Family of Companies Toronto, ON, M5R 1A6, CAN
Apr 22, 2018
Janssen Pharmaceutical, a company of Johnson & Johnson is hiring a Local Trial Manager. The preferred location is Toronto, ON, with consideration for a remote location in Canada. At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in hematology, 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.ca for more information. Responsibilities: + Overall project management of the Canadian component of multicentre, international registration studies and/or Medical Affairs studies (Phases 1-4) + Provide leadership to the local study team (e.g. Regional Site Managers/Monitors, document specialists, admin support) + Accountable to Global study team for trial coordination and study deliverables + Leadership of local study team. Contributions to local feasibility and investigator selection. Responsible for study start-up activities, subject recruitment and contingency plans at the country level, safety reporting, timely acquisition of quality data and trial documentation; study spend and forecast management + Ensure complete Trial Master File (essential trial documents) to parallel the progress of the clinical trial. + Audit and inspection readiness + Contribute to the development and improvement of departmental procedures and processes in the scope of the company’s effort towards continuous quality improvement. + This position may require up to 10% domestic and international travel. Qualifications + BSc, RN or MSc or equivalent degree in Biological Sciences + Minimum of three years in Clinical Research including site management experience in clinical trials (phases 2 and 3 at minimum). + Experience with overall trial management and risk based trial management is an asset. + In-depth knowledge of ICH-GCP and Canadian regulations + Strong project management skills with focus on study deliverables, trial/site oversight, quality and timelines + Knowledge of several therapeutic areas is an asset + Demonstrated skills in leadership and in the areas of judgement, communication, attention to detail, proactive problem-solving, analysis, negotiation, and innovation. + Strong prioritization, decision-making and adaptability skills. Ability to manage complexity and meet deadlines. Strategic, flexible and able to work well in a changing environment + Experience and high proficiency with electronic filing, data systems and reporting 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. Primary Location Canada-Ontario-Toronto Other Locations North America-Canada Organization Janssen Inc. (7710) Job Function Clinical Trial Administration Requisition ID 7163171215
J&J Family of Companies Toronto, ON, M5R 1A6, CAN
Apr 22, 2018
Janssen Pharmaceutical Companies of Johnson & Johnson, is currently hiring for a Clinical Project Manager / Local Trial Manager. The preferred location is Toronto, ON, with consideration for a remote location in Canada. 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. Responsibilities: + Overall project management of the Canadian component of multicentre, international registration studies and/or Medical Affairs studies (Phases 1-4) + Accountable to Global study teams for trial coordination and study deliverables for trial coordination and study deliverables + Provide leadership to the local study team (e.g. Regional Site Managers/Monitors, document specialists, admin support) + Responsible for local feasibility and investigator selection, study start-up activities, subject recruitment and contingency plans at the country level, safety reporting, timely acquisition of quality data and trial documentation; study spend and forecast management + Ensure complete Trial Master File (essential trial documents) to parallel the progress of the clinical trial. + Audit and inspection preparation + Contribute to the development and improvement of departmental procedures and processes in the scope of the company’s effort towards continuous quality improvement. + This position may require up to 10% domestic and international travel. Qualifications + A minimum of a Bachelor’s degree or RN in Biological Sciences is required. + Minimum of three years in Clinical Research including trial management and project management experience in clinical trials (phases 2 and 3 at minimum). + Experience with risk based trial management is an asset. + Knowledge of several therapeutic areas is as asset + In-depth knowledge of ICH-GCP and Canadian regulations + Strong project management skills with focus on study deliverables, oversight, quality and timelines + Ability to manage complexity; flexible and able to work well in a changing environment + Excellent oral and written communication skills including strong presentation skills. French (written and oral) is an asset + Experience and high proficiency with electronic filing, data systems and reporting + Strong attention to detail and focus on quality results + Proven interdependent and strategic partnering ability + Collaboration and conflict resolution skills. + Solid skills in the areas of judgement, problem-solving, leadership, analysis, negotiation, and innovation + Ability to work independently 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. Primary Location Canada-Ontario-Toronto Other Locations North America-Canada Organization Janssen Inc. (7710) Job Function Clinical Trial Administration Requisition ID 7739180330
J&J Family of Companies Toronto, ON, M5R 1A6, CAN
Apr 22, 2018
Janssen Pharmaceutical Companies of Johnson & Johnson est actuellement à la recherche d’un chef de projets, affaires cliniques/chef des essais cliniques locaux. L’endroit privilégié pour ce poste est Toronto (Ontario), mais il pourrait être possible de travailler à distance ailleurs au Canada. Chez Janssen, nous nous employons à répondre à certains des besoins médicaux non satisfaits les plus importants dans les domaines de l’oncologie, de l’immunologie, des neurosciences, des maladies infectieuses et des vaccins, des troubles métaboliques, des maladies chroniques et de la santé des femmes. Motivés par notre engagement envers les patients, nous offrons des produits, des solutions et des services novateurs dans le monde entier. Janssen Inc. est membre du groupe Janssen Pharmaceutical Companies of Johnson & Johnson. Veuillez visiter le site www.janssen.com/canada/fr pour de plus amples renseignements. Responsabilités : + Assurer la gestion globale de projets du volet canadien des études d’homologation multicentriques internationales ou des études menées par les Affaires médicales (phase I à IV). + Être responsable envers les équipes des études mondiales de la coordination des essais et des livrables des études. + Diriger l’équipe responsable des études locales (p. ex., chefs ou surveillants de site régional, spécialistes des documents, soutien administratif). + Assurer la faisabilité locale et la sélection des investigateurs, les activités de démarrage des études, le recrutement des sujets et les plans d’urgence à l’échelle nationale ainsi que les rapports d’innocuité, l’acquisition opportune de données de qualité et la documentation des essais; gérer les dépenses et les prévisions relatives aux études. + Tenir à jour un dossier maître complet des essais cliniques (documents essentiels relatifs aux essais) tout au long de la progression des essais cliniques. + Vérifier et inspecter les préparatifs. + Contribuer au développement et à l’optimisation des procédures et processus des services dans le cadre des efforts de l’entreprise visant l’amélioration continue de la qualité. + Le candidat retenu peut devoir se déplacer jusqu’à 10 % du temps (au Canada et à l’étranger). Qualifications + Baccalauréat ou diplôme de niveau supérieur en sciences biologiques ou titre d’infirmière ou d’infirmier autorisé(e). + Au moins trois ans d’expérience en recherche clinique, y compris en gestion d’essais et en gestion de projets dans le cadre d’essais cliniques (de phase II à III au minimum). + Expérience dans la gestion d’essais fondée sur les risques, un atout. + Connaissance de plusieurs secteurs thérapeutiques, un atout. + Connaissance approfondie des lignes directrices de la conférence internationale d’harmonisation, des bonnes pratiques cliniques ainsi que de la réglementation canadienne. + Solides compétences en gestion de projets, avec souci et contrôle des livrables des études, de la qualité et des délais correspondants. + Capacité à gérer les aspects complexes; souplesse et capacité à s’adapter et de travailler efficacement dans un environnement évolutif. + Excellentes aptitudes en communication orale et écrite, notamment en présentation. La maîtrise du français (tant à l’oral qu’à l’écrit), un atout. + Expérience et compétence élevée dans le classement de documents électroniques, les systèmes de données et la production de rapports. + Grand souci du détail et de la qualité des résultats. + Aptitudes démontrées pour la collaboration mutuelle et stratégique. + Aptitudes en collaboration et en résolution de conflit. + Solides compétences dans les domaines suivants : jugement, résolution de problèmes, leadership, analyse, négociation et innovation. + Capacité à travailler de façon autonome. La diversité et l’intégration sont des éléments centraux de la culture que nous partageons au sein du Groupe des entreprises Johnson & Johnson. Trois aspects importants sont essentiels à notre réussite : le recrutement, le perfectionnement, et la fidélisation d’un personnel qui représente la diversité de notre clientèle et des communautés dans lesquelles nous œuvrons. Nous avons à cœur d’offrir un environnement de travail respectueux, accueillant et accessible dans lequel tous les employés peuvent s’épanouir. Emplacement principal Canada-Ontario-Toronto Autres emplacements North America-Canada Organisation Janssen Inc. (7710) Fonction Clinical Trial Administration Requisition ID 7739180330
J&J Family of Companies Toronto, ON, M5R 1A6, CAN