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Pharmaceutical IT Business Systems Specialist
2 months ago
We are seeking a highly skilled Pharmaceutical IT Business Analyst to join our Life Sciences team in Toronto. As a dynamic consultant, you will play a crucial role in helping us address our clients' challenges.
Your main responsibilities will include:
- Developing a deep understanding of pharmaceutical industry processes and regulations (e.g., FDA compliance) to deliver effective business analysis and optimization.
- Eliciting, documenting, and analyzing business requirements for pharmaceutical projects, including drug development, clinical trials management, regulatory compliance, and pharmacovigilance.
- Evaluating, selecting, and implementing pharmaceutical-specific software solutions like EDC systems, LIMS, and ERP systems.
- Applying data modeling, mapping, and analysis techniques to support decision-making in drug discovery, clinical research, market analysis, and sales forecasting.
- Identifying inefficiencies and proposing innovative solutions to streamline operations, reduce costs, and boost productivity in pharmaceutical business processes.
- Ensuring knowledge of regulatory requirements and industry standards, including GCP, GMP, and ICH guidelines, to assess and mitigate risks related to regulatory non-compliance and data security breaches.
Requirements
- Bachelor's or Master's degree in a relevant field, such as Business Administration, Life Sciences, or Information Technology.
- A minimum of 5 years of experience as a Business Analyst in the pharmaceutical industry, demonstrating a strong understanding of industry-specific processes, regulations, and challenges.
- A proven track record of successfully eliciting, documenting, and analyzing business requirements for pharmaceutical projects, with a focus on drug development, clinical trials, and regulatory compliance.
- Experience in evaluating, selecting, and implementing pharmaceutical-specific software solutions, including EDC systems, LIMS, and ERP systems.
- Advanced proficiency in data modeling, mapping, and analysis techniques, using tools such as SQL, Excel, and data visualization software.
- Excellent communication, presentation, and stakeholder management skills, with the ability to effectively collaborate with cross-functional teams and drive consensus.
- Strong analytical and problem-solving abilities, with a keen eye for identifying inefficiencies and proposing innovative solutions.
- Thorough knowledge of regulatory requirements and industry standards in the pharmaceutical sector, including GCP, GMP, and ICH guidelines, with a focus on risk assessment and mitigation.
