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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Compliance Analyst
Location: Mississauga
Branche: Pharmaceuticals
Expertise: Quality Management
Experience: 3 years
* Adapt existing common laboratory methods into written procedures, using defined templates* Modernize existing procedures according to required templates* Develop and optimize report templates; train team members in template usage* Oversee the writing and completion of documents and assigned tasks within established timeline* Manage document reviews, resolve comments and secure approval* Provide technical support and troubleshooting for document management and revision* Ensure all job functions comply with internal standards* Coordinate with training and laboratory staff to assign training content* Perform all responsibilities under minimal supervision
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.
Medical Information Associate
Location: Canada
Branche: Pharmaceuticals
Expertise: Communications & Distribution
Experience: 2 years
Responsibilities Handle escalated (2nd-line) medical information inquiries from the outsourced Medical Information Contact Centre (MICC) during Canadian business hours (approx. 4 hours/day, Monday to Friday). Respond to urgent inquiries after business hours, if necessary, in collaboration with local medical affairs. Ensure responses are accurate, timely, and compliant with regulations and company SOPs. Coordinate the creation, review, and maintenance of Canadian-specific technical and medical response documents, including: Scientific response documents (LSRDs) FAQs, Q&As, medical letters, and technical sheets Ensure alignment with global content and Canadian regulations. Collaborate with MICC vendor and cross-functional teams (Medical, Regulatory, CMC, Legal, Communications) to ensure up-to-date and appropriate content is available. Analyze customer inquiry trends and share insights with Commercial, Innovation, and Medical teams to better address customer needs. Present quarterly summaries at the CHC (Consumer Healthcare) monthly team meeting. Deliver training sessions on Medical Information processes to internal teams (e.g., commercial and field) and MICC agents, particularly for new products. Support the analysis and response to product discontinuations, crisis situations, or inquiries from Health Canada and other external stakeholders. Provide inquiry metrics to Pharmacovigilance (PV) and/or Quality Assurance (QA) teams to support AE-PTC reconciliation reporting. Contribute to audit and inspection readiness, including Opella Global Quality Audits (GQA) and Health Canada inspections. Conduct quality checks on MICC responses to ensure scientific accuracy and compliance, identify trends, and implement Corrective and Preventive Actions (CAPAs) as needed. Maintain strong relationships with both Canadian and Global Medical Information teams to foster alignment and optimize knowledge sharing. Coordinate after-hours coverage and support logistics with MICC service providers.
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.
