What is the role of a pharmaceutical researcher?
A pharmaceutical researcher or pharmaceutical scientist contributes to expanding medical knowledge and drug development through clinical research. Their primary responsibility is to conduct and oversee various pharmaceutical research projects to ensure their successful execution and compliance with regulations. Pharmaceutical researchers are part of a team that includes other researchers, physicians, data analysts, and other stakeholders, working together to ensure the effective and ethical conduct of clinical trials and research studies.
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Validation Specialist
Location: Upton, Quebec.
Branche: Life Sciences
Expertise: HR & Recruiting
Experience: 2 years
Develop validation protocols to meet regulatory expectations from the FDA and Health Canada. Execute validation protocols according to the validation schedule, requalification, and the site master plan (including validation of equipment, cleaning, processes, and the computer system). Improve validation systems to comply with global and industry standards. Draft corresponding validation reports. Identify opportunities for improvement. Provide technical support to operations. Ensure the integrity and traceability of the information produced and reported, making necessary corrections in compliance with GMP and the company's internal standards. Perform document review, including revising and correcting internal documents (SOPs, IT, etc.).
Senior Director - Project Management
Location: Montréal
Branche: Pharmaceuticals
Expertise: Planning & Testing
Experience: 5 years
Responsibilities Lead and oversee complex, high-impact project management initiatives across the organization. Ensure alignment with strategic goals, regulatory requirements, and industry best practices. Champion and implement best practices in project planning, execution, and delivery. Drive the integration of innovative project management tools and methodologies. Manage a diverse portfolio of projects, including R&D, Manufacturing, expansion, site enhancements, and technology transfer. Establish, manage, and continuously improve the Project Management Office (PMO). Provide strategic direction, mentorship, and guidance to project managers and teams. Develop, implement, and refine project management methodologies and frameworks. Promote a culture of Six Sigma excellence and continuous improvement. Lead a group of project managers, fostering their professional growth and ensuring effective project execution. Collaborate with cross-functional teams to identify and eliminate process inefficiencies. Design, implement, and monitor improvement strategies tailored to pharmaceutical operations. Measure and report the impact of process enhancements on quality, compliance, and efficiency. Lead initiatives to streamline operations and enhance productivity. Evaluate and prioritize proposed capital investments, considering ROI, risk, and strategic impact. Collaborate with finance teams to allocate and manage budgets for capital projects. Monitor CAPEX spending, ensuring adherence to allocated budgets and financial targets. Drive strategic investment decisions to support long-term organizational goals. Communicate project status, risks, and outcomes effectively to senior management and stakeholders. Foster and maintain strong relationships with key stakeholders, including industry experts and regulatory bodies. Lead stakeholder engagement initiatives to ensure alignment and support for project objectives. Develop and deliver comprehensive reports and presentations to executive leadership. Utilize advanced analytics and data-driven insights to guide strategic and operational decisions. Monitor and analyze project performance metrics, ensuring compliance with industry standards. Implement data-driven approaches to enhance project outcomes and organizational performance. Drive the adoption of digital tools and technologies to support data-driven decision-making.
Pharmacovigilance Associate
Location: Ontario or Quebec
Branche: Pharmaceuticals
Expertise: Production & Manufacturing
Experience: 2 years
Responsibilities Data Entry of Individual Case Safety Reports (ICSRs) to the pharmacovigilance (PV) safety databases as per corporate and local requirements and timelines. Ensure that ICSRs for marketed products and medical devices subject to expedited reporting according to Canadian regulations are submitted to Health Canada within prescribed timelines. Monitor and support the preparation of written follow up requests to ensure timelines prescribed by local/global and corporate requirements are met. Perform reconciliations of the company's third party vendors programs, licensed partners as well as inter-departmental teams, as per corporate requirements and monitor key performance indicators. Provide support for the compliance monitoring of Individual Case Safety Reports (ICSRs) and generating metrics on case handling. Manage the external vendor training records including the launching of annual refresher training. Process Canada Vigilance queries and Access to Information requests/results. Support the analysis of reports in PV databases. Respond to queries and requests from internal and external stakeholders. Support the company's Project Leaders in compiling information for the LPSMF on a regular basis. Collaborate in developing and maintaining the local Pharmacovigilance standard operating procedures (SOPs), working instructions and job aids. Participate in the maintenance of the PV paper and electronic filing and archiving system according to corporate and Canadian requirements. Participate in the ongoing optimization of PV procedures as well as inter-departmental procedures affecting PV. Provide overall support to PV team activities.
Project Manager II
Location: Montreal
Branche: Food Production
Expertise: Production & Manufacturing
Experience: 3 years
Plan and execute the project according to Boccard Project Management System and internal best practices in place Accountable for delivering the project On Time, On Spec, and On Budget Track Project performance and meet budgetary objectives until project closure. Manage project budgets and report estimated versus actual costs, against physical progress. Analyze and explain technical and budgetary variances Carry out project closeout, prepare project postmortem and report final project KPIs Play an active role in maintaining the good relationship between the company and the client Liaison with all project stakeholders throughout project lifecycle and main point of contact for customer on project related communication Prepare quotations, draft proposals, and support technical alignments Execute and follow requests for modification to orders in compliance with contractual agreement and per internal rules Prepare and manage staffing plans - Identify the need for internal and external resources Manage the project team, organize and lead internal meetings. Organize and conduct project meetings (Kick Off Meeting, Weekly, Fortnightly, etc.) throughout lifecycle of project Apply standard Engineering practices to complete and/or review calculations, spreadsheets, drawings, piping layouts, and functional descriptions. Plan and coordinate with various departments the completion of tasks / milestones: to be delivered on time and on spec: design review, P&ID, 3D, highlighted P&IDs Manage and validate the technical calculations, specifications Work closely with the Supply Chain department: Plan the Supply Chain Kick Off meeting and comply with internal purchase order rules of engagements Write and validate reception protocols and approve installations Coordinate shop fabrication and onsite installation on assigned projects (may oversee equipment installation as necessary) Organize and facilitate acceptance tests (Simulations, FAT, SAT, Qualifications) Schedule and supervise the start-up Document project handover and execute Provisional and Final Acceptance certificates Prepare and provide project status reports to upper management / direct supervisor
Clinical and Medical Affairs Manager
Location: Richmond Hill
Branche: Life Sciences
Expertise: Research & Development
Experience: 3 years
The Clinical and Medical Affairs Manager will be responsible for ensuring compliance with regulations (SOPs, GCPs, FDA, Health Canada), managing clinical trials, and evaluating investigational sites in North America. Additionally, maintain the Trial Master File, collaborate with vendors for medical writing and data management, secure IRB approvals, and manage study budgets. The position also supports business development through relationship-building with clinicians and investigators and participates in medical affairs activities such as training sessions, continuing medical education events, and advisory boards. Ensure full compliance with all appropriate regulations: SOPs, GCPs, FDA, and Health Canada regulations. Assist in the planning, management, and execution of clinical trials. Help identify and evaluate investigational sites in North America. In collaboration with external vendors, assist in building, organizing, and maintaining the Trial Master File throughout the study. Collaborate with vendors for Medical Writing, Medical Monitoring, Data Management, and Statistics, as required. Help with planning and management of study budgets. Secure IRB study approvals and help with sites' IRB submissions and approvals. Support business development efforts by building and maintaining relationships with industry professionals, clinicians, and investigators. Collaborate and support North American medical affairs activities, such as training sessions, advisory boards, CME events, presentations, etc. Occasional travel may be required.
Project Manager
Location: Montréal
Branche: Food Production
Expertise: Production & Manufacturing
Experience: 3 years
Plan and execute the project according to Boccard Project Management System and internal best practices in place Accountable for delivering the project On Time, On Spec, and On Budget Track Project performance and meet budgetary objectives until project closure. Manage project budgets and report estimated versus actual costs, against physical progress. Analyze and explain technical and budgetary variances Carry out project closeout, prepare project postmortem and report final project KPIs Play an active role in maintaining the good relationship between the company and the client Liaison with all project stakeholders throughout project lifecycle and main point of contact for customer on project related communication Prepare quotations, draft proposals, and support technical alignments Execute and follow requests for modification to orders in compliance with contractual agreement and per internal rules Prepare and manage staffing plans - Identify the need for internal and external resources Manage the project team, organize and lead internal meetings. Organize and conduct project meetings (Kick Off Meeting, Weekly, Fortnightly, etc.) throughout lifecycle of project Apply standard Engineering practices to complete and/or review calculations, spreadsheets, drawings, piping layouts, and functional descriptions. Plan and coordinate with various departments the completion of tasks / milestones: to be delivered on time and on spec: design review, P&ID, 3D, highlighted P&IDs Manage and validate the technical calculations, specifications Work closely with the Supply Chain department: Plan the Supply Chain Kick Off meeting and comply with internal purchase order rules of engagements Write and validate reception protocols and approve installations Coordinate shop fabrication and onsite installation on assigned projects (may oversee equipment installation as necessary) Organize and facilitate acceptance tests (Simulations, FAT, SAT, Qualifications) Schedule and supervise the start-up Document project handover and execute Provisional and Final Acceptance certificates Prepare and provide project status reports to upper management / direct supervisor
Clinical Director - AI
Location: North York
Branche: Life Sciences
Expertise: HR & Recruiting
Experience: 5 years
The ideal candidate is skilled in extending Large Language Models for diverse applications, handling engineering and scaling challenges in large organizations, and has a strong understanding of both biology and underlying AI algorithms. Passion for using AI to revolutionize biomedical research and unlock scientific mysteries is key to success in this role. Lead a team of AI/ML and software engineers to evaluate, develop, extend and apply advance ML/AI methods for Clinical Trial design, analysis and optimization. Develop, implement, test and refine advanced AI/ML methods for the processing, analysis, modeling integration and visualization of large-scale biomedical data including text, imaging, and omics data. Use AI and ML methods for knowledge extraction from text and other structured data and for integrating this data with other types of structure and unstructured data using multi-modal genAI methods. Be in close contact with our clinical teams to discuss requirements, possible solutions and ways to integrate the proposed AI/ML methods to improve clinical trial design and execution. Work closely with the leading generative AI companies (our vendors) to make sure our products are state of the art and up to date. Work with developers, engineers, and ML Operations to deliver AI/ML solutions to product teams.
Director, Medical Devices
Location: Montréal
Branche: Medical devices
Expertise: Production & Manufacturing
Experience: 5 years
Manage and provide leadership to Medical Device Product Development and engineering teams. Collaborate with cross-functional teams involved in Medical Device Development, including Quality, Supply Chain, Manufacturing, and Marketing. Mitigate and manage Medical Device Program risks by establishing and executing contingency plans. Lead and implement customer-centric medical device design programs. Work closely with Key Opinion Leaders (KOLs) and participate in clinical experience programs. Hire and lead the medical devices engineering team. Provide capital and human resource recommendations to support the execution of the Company's Product Development plan. Act as a Subject Matter Expert, ensuring compliant and robust medical device development and design history files. Lead the transition from development to commercial launch for medical devices. Facilitate the closure of the development gap between drug and device. Work collaboratively with Product Marketing & Business Development personnel to define the scope and requirements of potential development projects and product requirements throughout the life cycle of medical device products. Oversee Electrical Safety and EMC testing of Medical Devices as applicable. Lead the establishment and management of the engineering and design review board for medical device changes. Review proposed design changes and manufacturing process changes for Medical Devices. Manage the creation and maintenance of design history files and related risk management files. Approve Corrective and Preventive Actions (CAPAs) and investigations.
What do pharmaceutical researchers do?
In this role, pharmaceutical researchers perform several essential tasks to facilitate successful pharmaceutical science. They collaborate with medical professionals, principal investigators, and other team members to define research objectives and design appropriate research protocols. Additionally, they work closely with regulatory authorities to obtain necessary approvals and ensure compliance with all relevant laws and guidelines governing pharmaceutical research.
They are responsible for recruiting and enrolling study participants, making sure that the appropriate target population is included. Maintaining accurate and organized records, managing data collection and analysis, and addressing any data-related issues that may arise during the study are also part of their responsibilities.
Moreover, pharmaceutical scientists need to lead the monitoring and auditing of research sites to ensure data quality, accuracy, and adherence to good clinical practice (GCP) standards. Implementing safety measures and conducting risk assessments are vital to ensuring patient safety throughout the research process.
Staying updated with the latest advancements in pharmaceutical research methodologies, technologies, and regulatory requirements is essential. By integrating cutting-edge practices, they can optimize innovation and success of research projects in the pharmaceutical field.
What are the required skills for a pharmaceutical researcher?
pharmaceutical researchers need a variety of skills. Strong leadership and project management abilities are essential for effectively coordinating and motivating teams throughout the research process. Excellent communication skills are also necessary for facilitating collaboration between team members, investigators, and other sector stakeholders. They should be able to communicate complex scientific information clearly and concisely.
In addition, in-depth knowledge of pharmaceutical research regulations, including GCP, and familiarity with the drug development process are vital for ensuring compliance and successful execution of studies. Analytical and problem-solving skills are also crucial for handling challenges and making informed decisions during the research process.
Where do pharmaceutical researchers work?
Pharmaceutical researchers can find job opportunities in various settings, including pharmaceutical companies, contract research organizations (CROs), academic institutions, hospitals, and government agencies. They may also work in specialized research facilities or medical device companies conducting clinical trials for new drugs and treatments.
Common pharmaceutical researcher responsibilities
Conduct and oversee pharmaceutical research projects, coordinating interdisciplinary teams;
Develop and implement research protocols, ensuring compliance with regulations and ethical guidelines;
Work closely with investigators and stakeholders to define research objectives and expectations;
Oversee participant recruitment and enrollment, ensuring the inclusion of the appropriate target population;
Maintain accurate and organized records of research progress, data collection, and analysis;
Perform data quality checks and address data-related issues as they arise;
Ensure patient safety by implementing safety measures and conducting risk assessments;
Monitor and audit research sites to ensure adherence to GCP standards;
Stay informed about the latest advancements in pharmaceutical research methodologies and regulatory requirements;
Communicate effectively with team members, investigators, and stakeholders to facilitate collaboration and project success;
Provide guidance and support to researchers and study coordinators throughout the research process.
Qualifications for pharmaceutical researchers
To become a pharmaceutical researcher, candidates should possess at least a Bachelor's degree in a relevant field, such as pharmaceutical sciences, life sciences, biomedical sciences, or healthcare management. Advanced degrees or certifications in pharmaceutical research or a related discipline are advantageous.
Other essential qualifications include:
- 2-4+ years of experience in pharmaceutical research or related healthcare projects;
- In-depth knowledge of pharmaceutical research regulations, including GCP;
- Strong project management and leadership skills;
- Excellent verbal and written communication abilities;
- Analytical and problem-solving skills;
- Familiarity with the drug development process and research methodologies;
- Ability to work collaboratively with interdisciplinary teams;
- A commitment to ensuring patient safety and contributing to advancements in healthcare through pharmaceutical research.
