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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Director of Regulatory
Location: Canada
Branche: Life Sciences
Expertise: Research & Development
Experience: 3 years
Responsible for preparing client proposals and generating new business, including leading presentations to potential RA clients, and participating in multifunctional presentations Prioritize and manage multiple simultaneous projects to meet budget (including invoice review), timelines and client expectations; anticipate and resolve emerging issues Responsible for development and implementation of RA activities including assessments, strategies, submissions and agency interactions, applying expert knowledge in core area of regulatory practice (e.g., CMC, Medical Devices, CTAs, US etc.) and at least basic knowledge outside of core area Maintain target billables by obtaining new business Creates opportunities to build agency relationships by participating in professional activities such as offering industry training, conference presentations, publications and webinars Leads client and agency interface, with responsibility for strengthening relationships and growing the business. Responsible for the quality of deliverables, by ensuring compliance with the company and client review and approval processes; identifies and implements opportunities for process improvement Develop and maintain partnerships with senior decision-makers to build the business, resolve significant issues, and create opportunities Analyze data, the regulatory environment and business objectives to make and implement recommendations, using judgement to identify innovative solutions while managing uncertainty. Lead and advise clients and cross-functional teams on agency interactions Leads decision-making and conflict resolution surrounding regulatory issues within cross-functional teams Proactively identifies, shares and interprets regulatory intelligence Manage multiple simultaneous projects to ensure that they are on budget, meet timelines and client expectations. Engages in continuous learning activities in order to provide effective consulting services and be a sought-after resource. Develop and manage 0-2 regulatory direct reports at Manager level or below, as assigned including but not limited to assignment delegation, time and budget management, skill and knowledge development
Environmental Health & Safety Manager
Location: Greater Toronto Area
Branche: Life Sciences
Expertise: HSEQ
Experience: 5 years
Secure site license to operate in compliance with all Health, Safety and Environment regulations and permits Liaise with external legal authorities and local stakeholders to avoid administrative notices Ensure full compliance with local, provincial and federal EHS and security regulations and standards Serve as primary EHS contact for regulatory authorities and certification bodies Coordinate site risk assessments and implement risk mitigation processes for administrative, injury, environmental and reputational hazards Allocate capex, opex and headcount resources to address major site risks Build and maintain EHS management system aligned with corporate requirements and digital core model Support global certification initiatives and ensure accuracy of consolidated EHS data reporting Define and drive continuous improvement plan based on site-specific risks and global Compelling Business Needs (CBNs) Prepare and lead regular EHS management reviews at site level and with senior management Establish and maintain robust EHS governance framework across all site operations Promote proactive EHS culture through training, education and targeted programs for all employees Provide in-depth EHS expertise and coaching to integrate safety and environmental considerations into projects Manage capture, investigation, mitigation and reporting of all EHS events to prevent recurrence Lead local EHS emergency response and crisis management activities Oversee EHS operational activities and manage site EHS team, including hiring, training, coaching, and performance evaluation
Industrial Engineer
Location: Charlottetown
Branche: Life Sciences
Expertise: Production & Manufacturing
Experience: 3 years
Responsibilities Assist in the planning, execution, and monitoring of capital and infrastructure projects, ensuring alignment with project goals, timelines, and budgets. Lead process and equipment validation ensuring regulatory compliance and consistent high-quality products. Monitor production data and Key Performance Indicators (KPIs) to highlight trends and opportunities for improvements. Ensure that all manufacturing processes and equipment meet the required standards and specifications through rigorous testing and validation. Follow IQ, OQ, PQ methodologies when applicable. Develop and manage qualification documentation for new equipment, processes, and systems, ensuring accuracy and completeness. Track the status of qualification activities and provide regular updates to stakeholders on progress and issues. Conduct assessments of packaging materials and processes to ensure they meet quality, safety, and compliance standards. Provide recommendations for packaging improvements and partner with suppliers and internal teams to implement changes. Identify and implement strategies and methodologies (Lean, Six Sigma) for continuous improvements, efficiency gains, and waste reduction including tracing performance of implemented changes.
HR Project Coordinator
Location: Montréal
Branche: Pharmaceuticals
Expertise: HR & Recruiting
Experience: 1 years
Project Planning & Tracking Define and monitor project scope, milestones, deliverables and dependencies Maintain detailed project plans, timelines and status updates Coordination & Documentation Prepare and update project artifacts: task lists, Gantt charts, meeting minutes and progress reports Review vendor materials and draft feedback on RFP submissions Stakeholder Engagement Serve as liaison between HR leadership, external vendors and internal teams Schedule and facilitate project meetings, ensuring clear agendas and action items Process Improvement Identify opportunities to streamline project workflows and documentation practices Assist in developing templates and tools to enhance team efficiency Compliance & Quality Verify all project activities adhere to AbbVie's HR policies, Quebec and federal regulations Support audit readiness by organizing records and evidence of compliance
Medical Information Specialist
Location: Canada
Branche: Pharmaceuticals
Expertise: Production & Manufacturing
Experience: 2 years
Responsibilities Manage and maintain scientifically accurate response documents for the company's products, including localization of global scientific response documents and management of escalations. Analyze medical information data across global and country markets, product lines, and inquiry categories to identify trends and insights. Generate regular and ad hoc trends and insights reports using Power BI and Salesforce dashboards, and respond to data queries from internal teams. Track medical information KPIs including escalation rates, response times, and inquiries open longer than two weeks; flag deviations from targets and escalate when needed. Maintain and update BI and Salesforce dashboards; support optimization of global medical information systems through testing, SOP updates, and template enhancements. Conduct monthly quality control of MICC vendor reporting and manage vendor interactions. Participate in cross-functional initiatives involving Medical, Regulatory, Quality, R&D, and customer service stakeholders to drive process and system improvements. Collaborate with medical, regulatory, R&D, and quality colleagues to ensure appropriate referrals and answers using a modern tracking and repository system.
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.
