Project Leader, Co-Development Project Management (Contract Role)

Responsible for the execution of various models of projects requiring partnership (co development in license tech transfer etc.) of a third party to get to submission and further through deficiencies to approval. Project leader will ensure the delivery of the projects according to corporate plan. The incumbent is expected to lead both internal project teams in the execution of Co-Development projects in conjunction with a project manager counterpart with a third party partner or contract manufacturing partners.

• Acts as the project manager for a third party project leading a Co-Development team and working closely with the third party partner team to develop and execute project plans and to ensure the timely delivery of the project.

• Responsible to facilitate input from SMEs from various Apotex functional groups as needed.

• Works closely with the Co-Development CMC & RA team in the execution of the project plan.

• Utilizes technical resources from the same team for the evaluation and execution of projects. Identifies project risks proposed risk mitigation and issue resolution in order to ensure adherence to plan with escalation as appropriate.

• Effectively demonstrates strong customer focus internally and externally. Develops effective working relationships with third party partners and internal functional groups through effective communication and collaboration. Utilizes strong negotiation skills as required.

• Utilizes the corporate systems for the tracking of projects and management of timelines e.g. EPM and appropriate utilizes the tools to communicate strategies risks and project timeline impacts.

• Utilizes the processes and systems that are developed within Co-Development to ensure storage of communications/ project decisions tracking project costs and other documentation requirements.

• Assists in the continuous improvement of operational processes (communication and documentation) within Co-Development to achieve efficient and effective execution of projects.

• Assists in the development of departmental standards and operating policies and procedures to ensure compliant processes in working with third party development partners.

• 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.

• Education

• • Degree/Diploma in Chemistry Biology Pharmaceutical or Health Sciences Pharmacy Pharmaceutical Technology Engineering or related science.
  • PMP Certification is an asset

• Knowledge Skills and Abilities
  • Excellent oral/written communication presentation interpersonal and conflict management skills.
  • Strong organizational skills: ability to work independently and manage priorities in a fast paced environment
  • Excellent understanding of Project Management principles and practice in a complex environment
  • Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word MS-Excel and MS-Project (or other PM software)
  • Knowledge of Canadian US EU and EU Regulatory guidelines is an asset.
  • Proven ability to effectively problem solves and provide guidance to various stakeholders.
  • Demonstrated knowledge of the Generic Drug development process.

• Experience

• • 4 or more years experience in the pharmaceutical industry in an R&D or related environment.
  • 3 or more years experience in a Project Management role/environment.
  • Prior experience leading/driving projects from initiation to launch.