Executive Pharmacokinetic
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Job Summary
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
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Job Summary
Executive - Pharmacokinetics responsible to implement CDISC standards in compliance with the regulatory requirement and managing all key activities of data management software development and validations. Perform pharmacokinetics and statistical analysis of concentration time data and to generate the randomization schemes as and when required.
Job Responsibilities
- Creating SDTM and ADaM datasets for the studies conducted by Apotex using CDISC standards
- Annotation of CRFs for the clinical studies conducted by Apotex.
- Development and validate of in-house SAS programs in line with the quality standards and regulations.
- Ensuring the validation of softwares are done in line with the applicable company quality standards and regulations
- Validation and review of clinical trial data.
- Creation of Specifications for Validation and review of SDTM ADaM and .
- Creating data sets tables listings and Procedural comparison sorting of source data.
- Ensures that assigned work is performed in accordance with GCP GLP SOPs regulatory requirements best practices and established safety standards as applicable
- Prepare justification for queries from regulatory agencies and tracking of regulatory deficiencies
- Conduct pharmacokinetic and statistical analysis of concentration-time data of bioequivalence studies in compliance with Standard Operating Procedures (SOPs).
- Generation/review of randomization schemes
- Preparation and/or review of 100% snapshot data.
- Preparation and review of pharmacokinetic/statistical section of Bio-study Reports in accordance with different regulatory guidance (e.g. FDA TPD and EMEA etc.).
- Preparation Protocol Synopses and review of in-house and CRO Protocol.
- Preparation of comprehensive summaries of pharmacology/toxicology information and other document necessary for regulatory submission.
- Assist in study feasibility exercise for new projects to conduct bioavailability and bioequivalence studies.
- Request and maintain the controlled copies including co-ordination with QA team.
- Maintain update and archive study related files and documents.
- Works as a member of a team to achieve all outcomes.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration Courage Perseverance and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program Global Quality policies and procedures Safety and Environment policies and HR policies.
- All other relevant duties as assigned.
Job Requirements
- Education
- Integrated Masters Degree in science
- Knowledge Skills and Abilities
- Expertise in area of statistical analysis SAS and/or bio-statistics.
- Excellent communication and interpersonal skills.
- Flexible to work
- Experience
- At least 4-5 years of industry experience in clinical trials related submissions for different regulatory agencies.
At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.
We offer 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.
About Company
Apotex is the largest Canadian-owned pharmaceutical company providing patients around the globe with quality, affordable medicines. We are an innovative global research and technology leader in generic pharmaceuticals that serves customers and partners in the U.S. market, as well as 1 ... View more
