Senior Program Manager
Job Summary - a concise overview of the job
The Senior Program Manager will provide strong leadership and program management expertise to develop and launch generic and sterile injectable products and support business continuity projects such as site transfers, new materials.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Program Management for development and launch of Endo’s generic and sterile injectable products including development and monitoring of related budget.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ Develop integrated product development plans for assigned programs.
§ Lead and foster high performance teams through the execution of the project plans.
§ Monitor performance versus plan. Actively track indicators to achieve milestones, be accountable for project deliverables to time, cost and quality.
§ Guide project teams to proactively anticipate challenges and assess risks, define solutions and mitigation plans.
§ Facilitate team preparation for Project Reviews. Communicate program progress and key issues to senior management.
§ Document key team information, decisions, actions, modifications to scope, resources, timelines and milestones and ensure project management systems are up to date.
§ Identify and contribute to implementing new process improvements to enhance project management capabilities including processes, templates, metrics and reporting.
§ Mentor less experienced Project managers.
§ May have supervisor responsibility. –
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Degree in Life sciences/Technology, will consider other backgrounds with related pharma or relevant Project Management experience.
§ 8 years of experience in the pharmaceutical industry in a field relating to drug development and/or technical operations. A minimum of 5 years of experience in project management or leading cross-functional teams.
§ Experience with development of Generic and sterile injectable products.
§ Experience with ANDA, PAS, and CBE regulatory submissions.
§ Experience in developing and managing project budgets.
§ PMP certification is preferred.
§ Demonstrated experience leading multifunctional program teams located across multiple geographies from inception through launch.
§ Expertise with application of project management practices and tools.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ In-depth knowledge of drug development process for generic and sterile injectable products.
§ Strong knowledge of the requirements related to multiple routes of regulatory submission ANDA, PAS, CBE.
§ Strong knowledge of project management processes and metrics.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Ability to proactively anticipate challenges and facilitate cross functional discussions for timely and candid exchange of information to reach alignment and path forward on complex issues.
§ Strong interpersonal skills are required. Incumbent must be able to work with and communicate clearly and concisely with colleagues at all levels of responsibility and authority, using multiple modes of communication.
§ Self-motivated, action oriented, able to adapt to changes in priorities.
§ Competent in use of MS office, especially MS Project, Word, Excel and PowerPoint.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Ability to travel up to 10-20% of time