Manager - Bioequivalence Project Management

Apotex Pharmachem India Pvt Ltd; Bengaluru; Sur place; INR 1 200 000 - 2 000 000; Plein temps

Résumé du poste

Apotex Inc. is seeking a Manager, Project Management - Bioequivalence to lead end-to-end BE and related clinical studies. You will oversee study planning, CRO management, regulatory coordination, and risk mitigation to ensure timely milestones from feasibility to archival.

Ideal candidates have extensive BE experience, strong leadership, budgeting, and cross-functional collaboration skills in a global pharmaceutical setting.

Qualifications

• Advanced proficiency in bioequivalence studies and project management.
• Experience leading BE-related clinical programs and CRO oversight.
• Strong budgeting, planning, and stakeholder management skills.

Responsabilités

• Lead end-to-end BE, Patient PK, POC, 505(b)(2) studies and CRO-outsourced trials.
• Develop project plans, timelines, resources, budgets, and risks; ensure on-time milestones.

Connaissances

Bioequivalence studies

Project Management

Patient PK Studies

POC & 505(b)(2)

CRO & Vendor Oversight

Risk Management

Budget Management

Communication & Interpersonal skills

Change Management

Planning & Prioritizing

Leadership

Judgement & Decision Making

Formation

M.Pharm./ MSc. / MBA

Description du poste

Manager, Proj Mgmt - Bioequivalence 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. For more information visit: www.apotex.com .

Job Summary

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.

Job Responsibilities

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.

Job Requirements

Education: Minimum M.Pharm./ 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.

Experience Level

Mid Level

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.