Pharmacokinetics Expert

About Apotex Inc.

Apotex Inc. is a global health company that produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, Apotex employs nearly 7,200 people in manufacturing, R&D, and commercial operations.

Job Summary

As an Executive - Pharmacokinetics, you will be responsible for implementing CDISC standards and managing key activities related to data management, software development, and validation. You will perform pharmacokinetics and statistical analysis of concentration-time data and generate randomization schemes as needed.

Key Responsibilities

• Create SDTM and ADaM datasets for Apotex studies using CDISC standards
• Annotate CRFs for clinical studies conducted by Apotex
• Develop and validate in-house SAS programs in line with quality standards and regulations
• Ensure software validation aligns with company quality standards and regulations
• Validate and review clinical trial data
• Create specifications for Define.xml, validate and review SDTM, ADaM, and Define.xml
• Create datasets, tables, listings, and procedural comparisons, sort source data
• Ensure work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices, and established safety standards
• Prepare justifications for queries from regulatory agencies and track regulatory deficiencies
• Conduct pharmacokinetic and statistical analysis of concentration-time data for bioequivalence studies in compliance with SOPs
• Generate and review randomization schemes
• Prepare and review 100% snapshot data
• Prepare and review pharmacokinetic/statistical sections of Bio-study Reports in accordance with regulatory guidance
• Prepare Protocol Synopses and review in-house and CRO Protocols
• Prepare comprehensive summaries of pharmacology/toxicology information and other documents necessary for regulatory submission
• Assist in study feasibility exercises for new projects to conduct bioavailability and bioequivalence studies
• Request and maintain controlled copies, coordinate with QA team
• Maintain, update, and archive study-related files and documents
• Work as a member of a team to achieve all outcomes
• Work in a safe manner, collaborating as a team member to achieve all outcomes
• Demonstrate behaviors that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion
• Ensure personal adherence to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies
• Perform all other relevant duties as assigned

Requirements

• Integrated Master's Degree in science
• Expertise in statistical analysis, SAS, and/or bio-statistics
• Excellent communication and interpersonal skills
• Flexible to work
• At least 4-5 years of industry experience in clinical trials related submissions for different regulatory agencies

At Apotex, we are committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.