Project Manager (m/f)

-May act as a standing or ad hoc member in short-, medium- or long-term work teams
-As needed and appropriate, addresses overall business project management - and/or project-specific questions; provides updates; delivers presentations; as relevant to project needs and plans
-Serves as the lead project manager representing the business functions on process improvement/optimization initiatives as well as system implementation projects
-Serves as Business Project Lead providing business project / initiative oversight (during planning, development, execution and closeout of project work) and project management methodology expertise
-Stays abreast of internal and external developments, trends, new system technologies and other dynamics relevant to the work of dept and as applicable the division, to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned business project, initiatives/projects and/or other recurring and ad hoc responsibilities
-Responsible and accountable for up-to-date project documentation following the relevant methodology
-Works closely with a host of cross-functional partners and stakeholders, including global department leadership, IT partners and others, to evaluate new and evolving projects
-Participates in and/or otherwise leads business project requirements gathering and other related systems and customer needs analysis
-Works with various internal and/or external partners to fully define specifications and plans of new business projects
-Responsible to review outcomes of feasibility and needs/impact assessments, cost, time and other requirements with sponsor, business lead, global department leaders, and other stakeholders in order to determine appropriateness and obtain approvals to develop project scope
-Develop detailed project plans, including objectives, deliverables, scope, timing, milestones, roles and responsibilities as well as, where applicable, project budgets
-Bachelor Degree required
-Project management certification is preferred, e.g., PMP, PgMP, PMI-ACP, PMI-RMP, PMI-SP
-Knowledge of, and/or training in, computer system validation and FDA guidance for Industry - Computerized Systems Used in Clinical Trials is a plus
-Broad understanding of international regulations, processes and issues in drug development
-A sound understanding of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH, and related systems that support clinical trials and clinical operations processes
-Experience working with clinical or non-clinical and information systems is a plus
-Advanced project management and process improvement skills
-Sound knowledge of and past experience working with best practice project management and operational excellence methodologies and tools
-Some project management experience across the software development lifecycle in a regulated IT environment, including requirements/specifications development and/or user acceptance testing for computer systems
-Must demonstrate knowledge of, and/or training in, regulatory and system compliance
-Fluent English and other language skills as needed
-Ability to travel approx. 15%

Weitere Qualifikationen: Project manager