This is a contract opportunity
Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the Country. We have an incredible team of bright, passionate, and committed individuals, who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our growing team.
The Associate Pharmacokinetics RD7, an expert in the area of pharmacology and pharmacokinetics, is a central member of the Pharmacokinetics Department who is responsible for the completion of all biostudy related tasks within the Pharmacokinetics Department. This includes the preparation and/or review of protocols and pharmacokinetic/statistical reports of comparative bioavailability studies performed by BioClinical Development (BCD) and of those conducted by outside CROs. He/she is also responsible for the preparation of comprehensive summaries of pharmacology/toxicology information for all necessary documents required for regulatory submission.
The Associate Pharmacokinetics RD7 also serves as an important scientific resource who provides professional support to other members of the Pharmacokinetics Department and is a vital contributor to the enhancement of the scientific foundation of BCD.
Org. Department Descriptor
- Scientific base operations departments
- Pharmacology and pharmacokinetic resource for BCD departments and R&D.
- Recommendation for bioequivalence studies design.
- Preparation of protocols for bioequivalence studies.
- Pharmacokinetic analysis of concentration-time data.
- Preparation of Pharmacokinetic/statistical section of Biostudy report.
- Preparation of comprehensive summaries of pharmacology and toxicology, used for Biowaivers and submission documents
1. Conduct pharmacokinetic and statistical analysis of data received from the bioanalytical laboratory in compliance with SOPs, DP’s
2. Prepare and review the pharmacokinetic/statistical section of Biostudy Reports in accordance with different regulatory guidance (e.g. FDA, TPD, EMEA)
3. Apply expertise and understanding of bioequivalence to review and replicate the pharmacokinetic/statistical section of Biostudy Reports prepared by CROs
4. Prepare the pharmacology/toxicology sections of necessary submission documents.
5. Develop protocols for bioequivalence studies
6. Review biostudy protocols prepared by CROs
7. Utilize knowledge and understanding of statistics to provide some statistical advice and support to other departments within BCD
- Take a lead role in the development, testing, validation and implementation of computer software/programs necessary for the Pharmacokinetics Department.
- Maintain and update the departmental database, computer system and biostudy files
Experimental or Methodological Design
- Constantly strive for improvement of procedures within the Department and the Division
Relationship with Internal/External Customers/Stakeholders
- As a member of biostudy project teams, communicate study progress to other departments in BCD and to Pharmacokinetics management.
- Provide professional and technical advice in the field of pharmacokinetics and pharmacology to biostudy project team members from other departments
- Collaborate with Quality Assurance auditors during project audits and respond to the audit observations in a timely manner
- Use effective communication and interpersonal skills to support the work of Biostudy Project Teams
Problem Solving Analysis
- Investigate, bring to the Manager’s attention and suggest possible solutions to problems arising within the Department resulting from faulty equipment, dated SOP or human error
- Support the Pharmacokinetics management in updating procedures and policies in the Pharmacokinetics Department
- Respond to more complex queiries of Biostudy team members and provide information regarding all aspects of biostudy work
- May assign specific project work to more junior members of the Pharmacokinetics Department to improve work efficiency
- Strive to expand the scientific basis of departmental operations and decision making processes
Leadership/Professional Development of Self & Others
- May serve as a team leader of biostudy project teams
- Train and provide guidance to more junior members of the Pharmacokinetics Department
- Maintain and update own pharmacokinetic, regulatory and statistical knowledge by reading relevant material
Compliance & Due Diligence
- May be involved in answering any queries on biostudies from regulatory agencies
- Conduct all work in compliance with SOP’s and safety guidelines
- Technical expertise in the area of pharmacokinetics, pharmacology and physiology
- Good understanding and command of basic statistical principles and procedures
- Good working knowledge of regulatory requirements for bioequivalence studies
- Excellent computer skills (Microsoft office, basic hardware/software maintenance)
- Good team member with desire to help and be helped
- Excellent organizational skills with high attention to details
- Excellent time management and project management skills
- Ability to work in a demanding, strictly regulated environment with very little tolerance for errors
- Initiative and innovative
- Ability and desire to learn
- Flexibility in response to a changing and evolving environment, deadline oriented
- Ability to work under pressure
- Excellent oral and written English communication skills
- Undergraduate degree in pharmacy/pharmacology/pharmaceutical studies + 18 months industry experience in pharmacokinetic analysis of human data
M.Sc. in pharmacokinetics/pharmacology/pharmaceutical sciences
- Previous experience in the area of bioequivalence is an asset.