Project Manager
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Description:

• This position is NonExempt.
• Hours over 40 will be paid at Time and a Half.
• Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines.
• Manage/direct all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle.
• Collaborate/work with project sponsors, business units and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success.
• Deliver quality project solutions to business problems or issues within defined budgets and/or timelines.
• Provide expert project guidance/support proactively through project completion.
• Provide tracking, reporting, and presentation to management and users.
• 7+ years experience

Primary Job Function

• Oversee the development of Clinical Evaluations (Plans and Reports) for new and existing medical devices, utilizing skill set of scientific project management, content expertise, knowledge of research design/methodology, and medical writing/editing.
• Provides scientific expertise throughout the development and implementation of clinical evaluations and other risk management deliverables.
• Work significantly with cross-functional teams and independent medical experts to develop deliverables for the Clinical Affairs team.
• Interacts with regulatory agencies as needed and will use their scientific and medical knowledge to provide directives to staff independently as well as directed by your manager.
• Core Job Responsibilities Takes lead as scientific project manager, writing/editing scientific content of deliverables and managing their timelines and the contribution of cross functional input.
• Writes Clinical Evaluation Plans and Clinical Evaluation Reports and other clinical deliverables , Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager.
• Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and/or by presenting regular updates to senior staff.
• Creates, manages, or participates in timelines of deliverables, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
• Interprets results in preparation for product