The pharmaceutical sector in Canada presents a spectrum of opportunities for professionals. Roles span from research and development, involving scientists and 436 Pharmaceutical jobs in Canada
Pharmaceutical Sales Representative, Dermatology/Calgary
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The Pharmaceutical Sales Representative will be responsible for product performance at a territory level, expected to be a disease category expert, a product champion, and develop strategic plans to maximize business opportunities.
You will report to the Business Manager and this role is a field-based role visiting Healthcare Professional clinics.
This is a 3-month contract with possibility of renewal.
Main Activities and Deliverables:
Responsible for the assigned territory to represent client’s products in person to healthcare providers, key selling messages about the product’s features, clinical benefits and safety information.
Develop a comprehensive territory business plan aimed at achieving and exceeding annual goals established by commercial leadership.
Promote dermatology product(s) within approved labelling in a comprehensive, fair, and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines.
Develop strong customer relationships by better understanding the customer’s needs.
Develop strategic plans and territory routing plans to maximize business opportunities.
Maximizes use of marketing resources to develop customer relationships to grow the customers’ confidence to prescribe the product for appropriate patients.
Provide feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results.
Manage efforts within assigned promotional budget.
Attend medical congresses and society meetings as needed.
Delivery medical education in person through Lunch and learns, CHE events, conferences for HCPs.
Job Experience and Qualifications:
University degree required (preferably in science or business).
Minimum of 2 years pharmaceutical, biotech or medical sales experience or working with Healthcare Professionals
Dynamic, enthusiastic, and passionate person
Understanding of the accreditation of continuing education and IMC code of ethical practices
Energetic, enthusiastic, and passionate.
Proven track record of success (winning performance).
Previous experience in cross-functional territory planning.
Strong business acumen, analytical skills, and strategic thinking.
Positive influence and impact on others, with the ability to quickly establish credibility and build strong business relationships.
Excellent oral and written communication skills.
Proficient in Microsoft Office and Outlook.
This role may require minimal overnight travel to meet territory coverage needs
Our Benefits:
Health Benefits as of day 1 of employment
Length of Service Awards
Quarterly Star Awards
Yearly Inizio Circle of Excellence Awards
Referral bonus
Library of online training courses
About Inizio Engage:
Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need.
We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them.
To learn more about Inizio Engage, visit us at:
Don't meet every job requirement? That's okay! We are dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit, please apply directly through our Careers page. We're excited to meet you!
ÉTUDIANT - Analyste assurance qualité Ligne Client / STUDENT - Customer Line Quality Assurance An...
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Job Description:
***English below***
Et si VOTRE aventure professionnelle commençait avec AIRBUS
Vous étudiez dans une université canadienne et vous recherchez un stage vous permettant d'acquérir une expérience professionnelle pendant vos études ?
Vous souhaitez travailler dans un contexte international, sur des projets hautement stratégiques et au sein d'une équipe enthousiaste, engagée et transnationale ? La Qualité Ligne Client et Essai en vol est LE département où il faut être
- Lieu de travail : Mirabel, Québec (Canada)
- Début : 5 Mai 2025
- Durée : 4 mois
En tant que stagiaire Analyste assurance qualité Ligne Client , votre rôle principal sera de faire des investigations et de cibler les écarts et mettre en œuvre des solutions innovantes.
Vos avantages
- Salaire attrayant et équilibre entre vie professionnelle et vie privée avec une semaine de 40 heures et possibilité de travail hybride (télétravail, 2 jours par semaine).
- Environnement international offrant la possibilité de nouer des contacts à l'échelle mondiale;
- Travailler avec des technologies modernes et diversifiées;
- Possibilité de participer à la communauté Generation Airbus (GenA) afin d'élargir votre propre réseau.
- Bien-être / Santé: Programme de rabais, service médical sur site, service de navette gratuite entre Montréal et Mirabel et application de covoiturage.
Chez Airbus, nous vous considérons comme un membre précieux de l'équipe et vous n'êtes pas embauché.e pour faire du café, mais vous êtes en contact étroit avec les interfaces et vous participez à nos réunions d'équipe hebdomadaires.
Vos missions et responsabilités
Votre tuteur/tutrice vous aidera à identifier vos objectifs professionnels et vous accompagnera dans le développement de vos compétences.
Vos principales activités seront les suivantes :
- Faire des investigations et de cibler les écarts et mettre en œuvre des solutions innovantes qui amélioreront notre façon de faire, la qualité et la satisfaction de nos clients et réduisent les coûts
- Faciliter des présentations et réunions multidisciplinaires
- Gérer des projets de qualité pour répondre aux exigences spécifiques et à la satisfaction des clients.
- Être un agent de changement pour promouvoir la culture de la qualité dans toute l'entreprise.
- Être capable d'enquêter et d'identifier les risques
- Gérer les priorités en fonction des objectifs
Compétences et qualifications souhaitées
Cette offre vous intéresse ? Êtes-vous notre candidat·e ?
Vous préparez actuellement un diplôme de niveau Universitaire (ou équivalent) dans le domaine du Génie ou une discipline apparentée ?
Durant vos études et expériences précédentes, vous avez développé les compétences suivantes :
- Une première expérience pratique dans le domaine manufacturière est souhaitable.
- Créativité et réflexion hors des sentiers battus.
- Haut niveau d'autonomie et de dynamisme (vous serez cependant accompagné par un tuteur du département)
- Bonnes compétences en communication avec une attitude ouverte d'esprit et proactive
- Connaissances des systèmes informatiques Microsoft, GSuite
Compétences linguistiques attendues :
Anglais : Intermédiaire
- Français : Avancé
Prochaines étapes de notre processus de sélection
Votre candidature sera analysée par un.e gestionnaire et un.e partenaire d'affaires en recrutement dans les prochains jours.
Si votre profil correspond aux pré-requis, vous serez invité.e à réaliser un entretien technique et un entretien RH.
Donnez une nouvelle dimension à votre carrière et postulez en ligne dès maintenant
Cet emploi exige une connaissance des risques de conformité potentiels et un engagement à agir avec intégrité, comme base de la réussite, de la réputation et de la croissance durable de la société.
À propos de nous
Constructeur d'avions commerciaux, avec les divisions Espace et Défense et Hélicoptères, Airbus est la plus grande entreprise aéronautique et spatiale d'Europe et un leader mondial.
Airbus s'est appuyé sur son solide héritage européen pour devenir véritablement international, avec quelque employé.e.s dans 180 sites dans le monde. La société possède des chaînes d'assemblage final d'avions et d'hélicoptères en Asie, en Europe et sur le continent américain.
Au Canada, plus de 4 500 personnes travaillent sur les dix sites et dans les bureaux d'Airbus et de ses filiales, dont plus de 4 000 au Québec.
Les principaux sites de production sont le siège du programme d'avions commerciaux A220 et Airbus Atlantique Canada, tous deux situés à Mirabel, au Québec. D'autres sites et filiales d'Airbus sont situés en Ontario - Airbus Helicopters Canada à Fort Erie et NAVBLUE à Waterloo - en Nouvelle-Écosse et au Québec.
Membre de la famille Airbus depuis plus de cinq ans, l'A220, conçu et assemblé au Québec et reconnu pour ses performances exceptionnelles et sa polyvalence, est devenu un choix privilégié pour les compagnies aériennes.
***
What if YOUR professional adventure started with AIRBUS
Are you studying at a Canadian university and looking for an internship to give you work experience during your studies?
You want to work in an international context, on highly strategic projects and in an enthusiastic, engaged, transnational team ? Airbus Quality Customer Line is THE place to be
- Location : Mirabel, Québec (Canada)
- Start : May 5th, 2025
- Duration : 4 months
As a Quality Analyst intern, your primary role will be to Investigate and target deviations and implement innovative solutions .
Your benefits- Attractive salary and work-life balance with a 40-hour week and the possibility of hybrid working (remote working, 2 days a week).
- International environment with the opportunity to network globally;
- Work with modern/diversified technologies;
- Opportunity to participate in the Generation Airbus (GenA) Community to expand your own network.
- Wellbeing/Health: Discount Program, on-site Medical Service, free shuttle service between Montreal and Mirabel and carpooling application.
At Airbus, we see you as a valuable team member and you are not hired to brew coffee, instead you are in close contact with the interfaces and are part of our weekly team meetings.
Your tasks and responsibilities
Your tutor will help you to identify your career objectives and support you in developing your skills.
Your main activities will be as follows:
- Investigate and target gaps and implement innovative solutions that will improve the way we do things, the quality and satisfaction of our customers and reduce costs
- Facilitate multidisciplinary presentations and meetings
- Manage quality projects to meet specific requirements and customer satisfaction.
- Be a change agent to promote the culture of quality throughout the company.
- Be able to investigate and identify risks
- Manage priorities based on objectives
Desired skills and qualifications
Interested in this opportunity? Are you our candidate?
Are you currently an enrolled full-time student for a University degree (or equivalent) in Engineering or a related discipline?
During your previous studies and experience, you have developed the following skills:
- First practical experience in the field of manufacturing is desirable.
- Creativity and thinking out of the box.
- High level of autonomy and drive (you will however be supported by a tutor from the department)
- Good communication skills with an open-minded and proactive attitude
- Self-organized
Language skills expected :
English:Intermediate
- French: Advanced
Next steps in our selection process
Your application will be analyzed by a manager and a recruitment business partner in the next few days.
If your profile matches the prerequisites, you will be invited to a technical interview and an HR interview.
Take your career to a new level and apply online now
This job requires an awareness of any potential compliance risks and a commitment to act with integrity, as the foundation for the Company's success, reputation and sustainable growth.
About us
A commercial aircraft manufacturer, with Space and Defence as well as Helicopters Divisions, Airbus is the largest aeronautics and space company in Europe and a worldwide leader.
Airbus has built on its strong European heritage to become truly international – with roughly 148,000 employees at 180 locations globally. The company has aircraft and helicopter final assembly lines across Asia, Europe and the Americas.
In Canada, more than 4,500 people work at the ten sites and offices of Airbus and its subsidiaries of which more than 4,000 are in Quebec.
The main production sites are the A220 commercial aircraft programme headquarters and Airbus Atlantic Canada, both in Mirabel, Quebec. Other Airbus sites and subsidiaries are located in Ontario - Airbus Helicopters Canada in Fort Erie and NAVBLUE in Waterloo - Nova Scotia and Quebec.
A member of the Airbus family for more than five years, the A220, designed and assembled in Quebec and acclaimed for its exceptional performance and versatility, has become a preferred choice for airlines.
This job requires an awareness of any potential compliance risks and a commitment to act with integrity, as the foundation for the Company's success, reputation and sustainable growth.
Company:
Airbus Canada Limited Partnership
Contract Type:
Internship
Experience Level:
Student
Job Family:
Support to Management
By submitting your CV or application you are consenting to Airbus using and storing information about you for monitoring purposes relating to your application or future employment. This information will only be used by Airbus.
Airbus is committed to achieving workforce diversity and creating an inclusive working environment. We welcome all applications irrespective of social and cultural background, age, gender, disability, sexual orientation or religious belief.
Airbus is, and always has been, committed to equal opportunities for all. As such, we will never ask for any type of monetary exchange in the frame of a recruitment process. Any impersonation of Airbus to do so should be reported to .
At Airbus, we support you to work, connect and collaborate more easily and flexibly. Wherever possible, we foster flexible working arrangements to stimulate innovative thinking.
Quality Assurance Analyst
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Would you like to put your quality assurance analyst skills to work on a large-scale project in collaboration with an exciting client Are you skilled at planning, organizing, and carrying out software testing? Do you enjoy sharing ideas, exploring new approaches, and taking on stimulating challenges? If this sounds like you, we can't wait to meet you Join an outstanding team and become part of a community of professionals who are truly passionate about software development.
As a QA Analyst at Spiria, you will be required to:- Review business requirements, system requirement specifications, design and other project documents to ensure adequate test coverage;
- Develop testing strategies, and identify tools and processes to optimize overall quality assurance activities;
- Create a complete quality assurance validation cycle;
- Create and update testing plans according to project progress;
- Run test scenarios and participate in quality assurance validation;
- Identify and document bugs found during testing;
- Contribute to advance the internal QA practice by sharing knowledge with others, harmonizing QA processes and defining good practices and guidelines;
- Participate in customer meetings and present QA work.
- Bilingual (French and English, written and spoken)*
- Attention to detail
- Analytical and resourceful
- User-oriented perspective
- Ability to do manual testing;
- Ability to develop test cases;
- Experience with bug tracking tools (ex: Azure DevOps, Xray for Jira);
- Experience in API testing;
- Significant experience with manual testing;
- Knowledge of Agile methodology and solid understanding of the software development life cycle (SDLC)
- Asset: Experience with database testing
- Asset : Experience with test automation tools (Selenium or equivalent)
- Asset: Experience with version control (Git, Azure DevOps or equivalent).
- Flexible work arrangements (remote, hybrid, or in-person), because what truly matters is not where you are, but what you do.
- Salary range: $65 000 to $2 000, based on a 37.5-hour workweek.
- 100% hybrid work policy, because it's usually not about where you are, but what you do;
- In addition to vacation weeks, our HUG program allows for unlimited leave when things aren't going your way, plus additional vacation days during the Christmas period;
- DPSP-RRSP program with employer contribution;
- Complete group insurance plan, including telemedicine;
- Spiri-Flex program to ensure a healthy body, mind and environment, we offer a total reimbursement of 300 per year for expenses related to health, wellness or work at home.
Work Environment
We believe work-life balance is essential. We make this possible through a flexible work organization and a personalized working style. Whether you're at the office or in your location of choice, what matters most is the impact of your work, not where you're doing it from.
About Us
At Spiria, we're a team of over 150 professionals across Canada. For more than 20 years, we've been building custom software solutions driven by a strong commitment to code quality, technological excellence, collaborative creation, and customer satisfaction.
- Bilingualism is essential for this role. The person in this role will need to collaborate with internal and external clients across North America in both French and English for all tasks.
At Spiria, we believe diversity is a major strength. We therefore adhere to the principle of employment equity and encourage applications from women, visible minorities, Indigenous people, persons with disabilities, LGBTQIA2S+ individuals, and other marginalized communities.
AI Notice
Our recruitment tools use AI to assist in the initial screening of applications, but never replace the intuition and expertise of our recruitment teams.
Senior Regulatory Affairs Specialist
Posted 2 days ago
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**JOB TITLE:**
**Sr Regulatory Affairs Specialist (CMC)**
**KEY RESPONSIBILITIES:**
Plan, manage, and coordinate the preparation, compilation, filing, and approval of high-quality regulatory submissions (NDS, SNDS, ANDS, SANDS, NC, DINA, PDC, etc.) for presentation to Health Canada in eCTD format and as per Health Canadas Guidelines to obtain marketing authorization for new or marketed drug products.
Preparation and review of responses to Health Canada letters (e.g. SDN, NON, NOD, Clarifaxes) in a timely manner; assist in negotiations with Health Canada to ensure prompt regulatory approvals of dossiers under review and in preparation.
Help to manage all regulatory CMC aspects of Bausch Health Canada Inc., Salix and Orapharma products in Canada throughout their lifecycle:
Evaluation of change controls, determination of necessary requirements, preparation and compilation of L3 submissions to maintain the conformity and life cycle of currently marketed products; update of CPIDs and associated regulatory dossiers maintenance.
Projects: critical assessment of data and documents to identify gaps compared to regulatory requirements; identify the required documentation and content of CMC sections in support of registrations in Canada.
Formulate CMC regulatory strategy for marketed products in collaboration with RA Product Leads.
Maintain and ensure regulatory product compliance. Interact, communicate and negotiate with internal and external stakeholders like Health Canada and CMOs.
Maintain current awareness of all regulatory guidelines (Health Canada, ICH, etc.).
Mentor other members of the team on technical aspects.
Support the Sr. Manager RA-CMC, and the GRA-CMC team (US/EU/Latam) as necessary.
**QUALIFICATIONS:**
University Degree, B.Sc. or higher (Masters degree or a PhD)in Health Sciences. A DESS in Drug Development and/or a RAC certification is an asset. Relevant Quality Assurance (analytical)/Compliance experience is also an asset.
Minimum of 6 years of relevant CMC experience in Canadian Pharmaceutical Regulatory Affairs, with experience/expertise in managing drug products and lifecycle from a CMC perspective. Experience with Biologics is also an asset.
Excellent working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.
Excellent organizational and communication skills (oral and written).
Bilingual (English and French).
Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines.
Entrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility & flexibility; team player and respect of others.
Computer Literacy
Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat, Veeva, Docubridge, Trackwise.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
Senior Regulatory Affairs Specialist
Posted 2 days ago
Job Viewed
Job Description
**JOB TITLE:**
**Sr Regulatory Affairs Specialist (CMC)**
**KEY RESPONSIBILITIES:**
Plan, manage, and coordinate the preparation, compilation, filing, and approval of high-quality regulatory submissions (NDS, SNDS, ANDS, SANDS, NC, DINA, PDC, etc.) for presentation to Health Canada in eCTD format and as per Health Canadas Guidelines to obtain marketing authorization for new or marketed drug products.
Preparation and review of responses to Health Canada letters (e.g. SDN, NON, NOD, Clarifaxes) in a timely manner; assist in negotiations with Health Canada to ensure prompt regulatory approvals of dossiers under review and in preparation.
Help to manage all regulatory CMC aspects of Bausch Health Canada Inc., Salix and Orapharma products in Canada throughout their lifecycle:
Evaluation of change controls, determination of necessary requirements, preparation and compilation of L3 submissions to maintain the conformity and life cycle of currently marketed products; update of CPIDs and associated regulatory dossiers maintenance.
Projects: critical assessment of data and documents to identify gaps compared to regulatory requirements; identify the required documentation and content of CMC sections in support of registrations in Canada.
Formulate CMC regulatory strategy for marketed products in collaboration with RA Product Leads.
Maintain and ensure regulatory product compliance. Interact, communicate and negotiate with internal and external stakeholders like Health Canada and CMOs.
Maintain current awareness of all regulatory guidelines (Health Canada, ICH, etc.).
Mentor other members of the team on technical aspects.
Support the Sr. Manager RA-CMC, and the GRA-CMC team (US/EU/Latam) as necessary.
**QUALIFICATIONS:**
University Degree, B.Sc. or higher (Masters degree or a PhD)in Health Sciences. A DESS in Drug Development and/or a RAC certification is an asset. Relevant Quality Assurance (analytical)/Compliance experience is also an asset.
Minimum of 6 years of relevant CMC experience in Canadian Pharmaceutical Regulatory Affairs, with experience/expertise in managing drug products and lifecycle from a CMC perspective. Experience with Biologics is also an asset.
Excellent working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.
Excellent organizational and communication skills (oral and written).
Bilingual (English and French).
Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines.
Entrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility & flexibility; team player and respect of others.
Computer Literacy
Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat, Veeva, Docubridge, Trackwise.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
FSP Clinical Research Associate I - Oncology (Quebec or Ontario)
Posted 2 days ago
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Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Job Responsibilities**
Take on the role of monitoring investigator sites strategically, analyzing root causes, and implementing solutions to improve compliance and minimize risks.
Assess investigational products through physical inventory and records review.
Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring activities.
Promptly report observed deficiencies and issues to clinical management and follow through to resolution.
Maintain continuous contact with investigative sites to confirm protocol adherence, resolve issues, and ensure timely data recording.
Conduct monitoring tasks and visits according to the approved monitoring plan.
Collaborate with project team members to resolve issues/findings.
Provide trial status tracking and progress updates to the Clinical Team Manager (CTM).
Update study systems per agreed study conventions (e.g., Clinical Trial Management System, CTMS).
Participate in investigator meetings as necessary.
Identify potential investigators to ensure the acceptability of qualified sites.
Commence clinical trial sites in accordance with relevant procedures to guarantee adherence to protocol and regulatory requirements.
Ensure trial closeout and retrieval of trial materials.
Ensure essential documents are complete and in place according to ICH-GCP and applicable regulations.
Conduct on-site file reviews as per project specifications.
Contribute to project publications/tools and share ideas/suggestions with team members.
Facilitate effective communication between investigative sites, the client company, and the PPD project team.
Complete administrative tasks such as expense reports and timesheets in a timely manner.
Address company, client, and regulatory needs/audits/inspections.
**Requirements**
Oncology highly preferred, bilingual French/English, located in Quebec or ON
Oncology highly preferred located in Ontario
6 months -1year of direct onsite monitoring experience highly preferred
Bachelor''s degree in a related field or equivalent experience.
Proven ability to monitor investigator sites and assess investigational product compliance.
Outstanding critical thinking and problem-solving skills.
Proficient knowledge of ICH-GCP and regulatory standards.
Excellent communication and organizational skills.
Ability to work collaboratively within a team to achieve flawless results.
Bilingual proficiency in French and English (required for Quebec).
Join us to make a significant impact in the field of oncology research and be part of a world-class team dedicated to scientific excellence!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Senior Clinical Research Associate - FSP (Bilingual QC or ON Canada) - Oncology
Posted 2 days ago
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Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, youu2019ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on u2013 now and in the future.
Our global Clinical Operations colleagues within our PPDu00ae clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
This position requires overnight travel either regionally or nationally, dependent on business needs.
**Discover Impactful Work:**
Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**A day in the Life:**
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to other project work and initiatives for process improvement, as required.
**Keys to Success:**
**Education**
Bachelor''s degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
**Experience**
**Required a bilingual Sn CRA in Canada; Ontario or Quebec, for FSP resourcing purposes. Must have CRA experience in hematology/oncology in addition to speaking both French and English.**
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
Valid driver''s license where applicable.
In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills and Abilities:**
Effective clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manages Risk Based Monitoring concepts and processes
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customersu2019 underlying issues
Effective interpersonal skills
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable in a wide range of scenarios
Ability to work in a team or independently as required
Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
**Work Environment**
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
The salary range estimated for this position is $83,000 annually - $125,000 annually. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer. We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
A choice of national medical and dental plans, and a national vision plan - A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA) - Tax-advantaged savings and spending accounts and commuter benefits - Employee assistance program - Paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
**Apply today!**
** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
La mau00eetrise de la langue anglaise est requise pour garantir une communication et une collaboration efficaces avec les membres de l''u00e9quipe et les dirigeants d''entreprise dans divers endroits u00e0 travers le monde, y compris aux u00c9tats-Unis.
English language proficiency is required to ensure effective communication and collaboration with team members and business leaders in various locations globally, including the United States.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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FSP Clinical Research Associate I - Oncology (Quebec or Ontario)
Posted 2 days ago
Job Viewed
Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Job Responsibilities**
Take on the role of monitoring investigator sites strategically, analyzing root causes, and implementing solutions to improve compliance and minimize risks.
Assess investigational products through physical inventory and records review.
Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring activities.
Promptly report observed deficiencies and issues to clinical management and follow through to resolution.
Maintain continuous contact with investigative sites to confirm protocol adherence, resolve issues, and ensure timely data recording.
Conduct monitoring tasks and visits according to the approved monitoring plan.
Collaborate with project team members to resolve issues/findings.
Provide trial status tracking and progress updates to the Clinical Team Manager (CTM).
Update study systems per agreed study conventions (e.g., Clinical Trial Management System, CTMS).
Participate in investigator meetings as necessary.
Identify potential investigators to ensure the acceptability of qualified sites.
Commence clinical trial sites in accordance with relevant procedures to guarantee adherence to protocol and regulatory requirements.
Ensure trial closeout and retrieval of trial materials.
Ensure essential documents are complete and in place according to ICH-GCP and applicable regulations.
Conduct on-site file reviews as per project specifications.
Contribute to project publications/tools and share ideas/suggestions with team members.
Facilitate effective communication between investigative sites, the client company, and the PPD project team.
Complete administrative tasks such as expense reports and timesheets in a timely manner.
Address company, client, and regulatory needs/audits/inspections.
**Requirements**
Oncology highly preferred, bilingual French/English, located in Quebec or ON
Oncology highly preferred located in Ontario
6 months -1year of direct onsite monitoring experience highly preferred
Bachelor''s degree in a related field or equivalent experience.
Proven ability to monitor investigator sites and assess investigational product compliance.
Outstanding critical thinking and problem-solving skills.
Proficient knowledge of ICH-GCP and regulatory standards.
Excellent communication and organizational skills.
Ability to work collaboratively within a team to achieve flawless results.
Bilingual proficiency in French and English (required for Quebec).
Join us to make a significant impact in the field of oncology research and be part of a world-class team dedicated to scientific excellence!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Senior Clinical Research Associate - FSP (Bilingual QC or ON Canada) - Oncology
Posted 2 days ago
Job Viewed
Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, youu2019ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on u2013 now and in the future.
Our global Clinical Operations colleagues within our PPDu00ae clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
This position requires overnight travel either regionally or nationally, dependent on business needs.
**Discover Impactful Work:**
Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**A day in the Life:**
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to other project work and initiatives for process improvement, as required.
**Keys to Success:**
**Education**
Bachelor''s degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
**Experience**
**Required a bilingual Sn CRA in Canada; Ontario or Quebec, for FSP resourcing purposes. Must have CRA experience in hematology/oncology in addition to speaking both French and English.**
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
Valid driver''s license where applicable.
In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills and Abilities:**
Effective clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manages Risk Based Monitoring concepts and processes
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customersu2019 underlying issues
Effective interpersonal skills
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable in a wide range of scenarios
Ability to work in a team or independently as required
Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
**Work Environment**
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
The salary range estimated for this position is $83,000 annually - $125,000 annually. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer. We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
A choice of national medical and dental plans, and a national vision plan - A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA) - Tax-advantaged savings and spending accounts and commuter benefits - Employee assistance program - Paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
**Apply today!**
** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
La mau00eetrise de la langue anglaise est requise pour garantir une communication et une collaboration efficaces avec les membres de l''u00e9quipe et les dirigeants d''entreprise dans divers endroits u00e0 travers le monde, y compris aux u00c9tats-Unis.
English language proficiency is required to ensure effective communication and collaboration with team members and business leaders in various locations globally, including the United States.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Quality Assurance Analyst - Customer Support
Posted today
Job Viewed
Job Description
The responsibilities for this role include:
+ Plan and drive adoption of global quality management framework and standards within the call center
+ Partner with the Quality Management Center of Excellence to drive expansion of their scope to international markets
+ Ensure adherence to quality frameworks across international markets
+ Leverage data to optimize service and drive improvements
+ Advocate for international inclusion on quality tech roadmaps
+ Analyzing and operationalizing data from multiple sources (Ex. Manual evaluations, QA dashboards, customer feedback, operational performance metrics) to generate actionable insights for process and service optimization
+ Utilize data to develop recommendations that drive measurable improvements in customer experience and outcomes
+ Leverage quality data to enable targeted coaching, refine training programs, and advocate for process and technology improvements across internal and partner teams
+ Communicate data-backed insights and recommendations to executive leadership, driving transparency, accountability and alignment with business objectives
Qualifications for this role include:
+ 3+ years of experience leading a quality assurance program in a customer support environment
+ Strong change management/project management skills
+ Proven experience with managing, designing, and implementing contact center quality management frameworks
+ Bachelor's Degree
+ Previous experience working within a BPO environment would be an asset
+ Previous experience working across international markets would be an asset
OTHER:
+ This position would require you to 3 days in office in downtown Toronto
+ Monday - Friday 9am - 5pm standard business hours
+ Potential for extension
Pay and Benefits
The pay range for this position is $50.82 - $58.35/hr.
Workplace Type
This is a hybrid position in Toronto,ON.
À propos de TEKsystems et TEKsystems Global Services
Nous sommes un fournisseur de services aux entreprises et de technologies. Nous accélérons la transformation de nos clients. Notre compétence en stratégie, conception, exécution et opérations libère la valeur de l'entreprise par un éventail de solutions. Nous sommes une équipe de 80 000 personnes qui collaborent avec plus de 60 000 clients, notamment 80 % du Fortune 500 en Amérique du Nord, Europe et Asie, qui collaborent avec nous dans le cadre de nos capacités full-stack et notre rythme. Nous sommes des penseurs stratégiques, des collaborateurs pratiques qui aident les clients à exploiter le changement et maîtriser le dynamisme de la technologie. Nous bâtissons le futur en livrant les résultats et en créant un impact positif dans nos communautés mondiales. TEKsystems et TEKsystems Global Services sont des entreprises d'Allegis Group. Découvrez d'autres informations à TEKsystems.com.
About TEKsystems and TEKsystems Global Services
We're a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We're a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We're strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We're building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.