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.).
Compliance Specialist (Human Biological Samples)
Location: Mississauga
Branche: Pharmaceuticals
Expertise: Quality Management
Experience: 2 years
Collaborate with internal teams in locating documentation and reviewing consent related to HBS. Assist the Biobank lead and team in linking samples to consent forms. Duties may include handling of HBS during the reconciliation and curation process. Work with Biobank leads to ensure that learning from HBS related issues are identified and analysed to enable continuous process improvement. Review consent forms for use restriction & storage information. Electronically manage HBS retrievals, including receipt, tracking, review and approval of requests from internal requestors. Confirm requests against the informed consent, raise requests as the need arises. Ensure sample manifests are completed to document the HBS transport or receipt. Assist the Biobank lead in identifying & managing sample sharing between teams. Work with the Biobanks to optimise processes around Biobank requirements for compliance. Work with various Biobanks to ensure sample compliance. Participate & contribute to team meeting & discussions. Support team members in delivering the Departmental goals. Assist in knowledge curation to allow decision making on inventory which maybe in-house, or third parties. Assist with the resolution of issue and queries relating to HBS within the inventory. Maintain records for HBS stored until it meets final disposal and follow destruction process when initiated.
Automation Engineer
Location: Greater Toronto Area
Branche: Pharmaceuticals
Expertise: Production & Manufacturing
Experience: 2 years
Maintain, troubleshoot, and repair automated systems, including PLCs, HMIs, SCADA, robotics, and other control systems. Diagnose and resolve electrical, mechanical, and software-related issues to minimize downtime and maintain production efficiency. Perform regular calibration of sensors, instruments, and automated equipment to ensure accuracy and compliance with industry standards. Modify/optimize control programs to enhance process performance and production quality. Maintain accurate records of all maintenance activities, calibrations, and software changes. Ensure compliance with Good Manufacturing Practices (GMP), FDA, and other regulatory requirements by adhering to established protocols and guidelines for pharmaceutical industry standards. Identify opportunities to improve automation processes, enhance system reliability, and reduce operational costs. Collaborate with engineering teams to implement upgrades and modifications to systems. Work closely with production, quality assurance, and engineering teams to support manufacturing objectives. Provide training and guidance to operators and junior technicians on the proper use of automated systems. Strong knowledge of PLC programming and industrial automation systems. Experience with control system architecture, including SCADA, HMI interfaces, and networks Proficient in troubleshooting and repairing mechanical, electrical, and software components Familiarity with sensors, actuators, motors, VFDs, and servo systems. Ability to interpret technical drawings, P&IDs, and electrical schematics. Strong analytical and diagnostic skills to identify and resolve system inefficiencies. Proactive mindset with the ability to prioritize and manage tasks in a high-pressure situations
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.
Project Manger (Engineering)
Location: Greater Toronto Area
Branche: Pharmaceuticals
Expertise: Production & Manufacturing
Experience: 2 years
Develop and manage project schedules, budgets, resource plans, KPIs, and progress reporting. Support governance meetings by preparing materials, capturing action items, and ensuring follow-through Drive alignment across program teams and ensure adherence to the Manufacturing 4.0 roadmap Act as a liaison between cross-functional teams, including manufacturing, IT, and business process owners. Foster collaboration across various communities of practice, such as MES, Kinaxis, and M&S Plan-to-Manufacture teams. Facilitate stakeholder engagement through effective communication strategies and updates Oversee the deployment of digital tools, such as MES systems, Kinaxis, and iShift. Identify areas for continuous improvement and align solutions with operational excellence goals. Implement change management strategies for smooth adoption of new processes Lead training, workshops, and knowledge-sharing sessions to support cultural and operational shifts Ensure all project activities comply with regulatory requirements and company standards. Maintain documentation to support audits and inspections.
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.
Data Analyst
Location: Toronto
Branche: Pharmaceuticals
Expertise: Marketing & Sales
Experience: 2 years
Responsibilities Analyze sales, market, and performance data to identify trends and actionable insights. Create clear and impactful data visualizations and reports to support strategic decision-making. Collaborate with cross-functional teams, including sales, marketing, and leadership, to inform business strategies. Contribute to sales and marketing analytics projects, gaining exposure to senior leadership and business-critical initiatives.
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
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
Quality Manager (Engineering)
Location: Greater Toronto Area
Branche: Pharmaceuticals
Expertise: Production & Manufacturing
Experience: 2 years
Provide quality oversight for manufacturing process equipment, CIP, SIP, Thermal, Utilities, HVAC qualification and computerized system validation activities pertaining to B100 licensure, start-up and lifecycle management. Review/approve validation deliverables (i.e. URS, specification documents, risk assessment, test strategies, protocols, executed raw data packages, reports, validation plans, SOPs, Equipment registration in SAP) in accordance with internal and regulatory policies. Review, assess and approve change controls, deviations and corrective plans, resulting from validation/qualification studies. As required, represent Quality Operations on project team and/or sub-teams and/or project working groups to provide direction on validation issues with respect to compliance. Responsible for maintaining validation awareness by screening and reporting on significant validation trends and changes through literature reviews, meetings, and peer discussions within the industry.
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.
