Manager, Proj Mgmt Bioequivalence
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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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- Lead and manage end-to-end execution of Bioequivalence (BE) Patient PK POC 505(b)(2) and CRO-outsourced clinical studies. Responsible for project planning stakeholder management CRO oversight regulatory coordination risk mitigation budget control and timely delivery of study milestones from feasibility through final report and archival
- Project Leadership
- Serve as the single point of accountability for assigned studies and clinical programs.
- Develop project plans timelines resource allocation budgets and risk mitigation strategies.
- Drive on-time delivery of project milestones reports and study closures.
- Clinical & Study Management
- Oversee execution of BE Patient PK POC and 505(b)(2) studies.
- Ensure study objectives are achieved while maintaining quality compliance and timeline commitments.
- Monitor critical path activities and proactively resolve operational issues.
- CRO & Vendor Management
- Identify qualify and manage CROs laboratories and vendors.
- Track CRO performance study deliverables budgets and compliance metrics.
- Escalate and resolve project risks impacting scope quality cost or timelines.
- Regulatory & Compliance
- Coordinate regulatory submissions ethics approvals and inspection readiness.
- Ensure compliance with GCP SOPs protocol requirements and applicable global regulations.
- Cross-functional Coordination
- Collaborate with Clinical Operations Bioanalytical Regulatory Affairs Data Management Medical Writing QA Supply Chain and Sponsors.
- Facilitate effective communication and alignment among all stakeholders.
- Governance & Reporting
- Maintain project dashboards risk registers trackers and KPI metrics.
- Provide regular project updates and management reports to leadership and sponsors.
- Education
- Minimum ./ MSc. / MBA.
- Knowledge Skills and Abilities
- Minimum of Advanced proficiency level in
- Bioequivalence studies
- Project Management
- Patient PK Studies
- POC & 505(b)(2) Programs
- CRO & Vendor Oversight
- Risk & Budget Management
- Communication & Interpersonal skills.
- Change Management
- Drive for Results
- Planning & Prioritizing
- Leadership
- Judgement & Decision Making
- Experience
- Minimum 15 years of experience
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.
Required Experience:
Manager
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
