- Develop and lead cross-functional teams (internal and external) to deliver project within established timelines.
- Develop, maintain, and execute against project plans to ensure project goals are met.
- Serve as primary project manager (internally and externally) for assigned project. Utilize project management skills to ensure success, including: schedule development, issue resolution, communication management, workstream & deliverable tracking, risk management, relationship management, and prioritization.
- Serve as a liaison both internally and externally to assure products are manufactured with cGMP compliance, regulatory needs are met, and issues with projects are adequately resolved to assure timelines are maintained.
- Manage ongoing stability studies including launch activities, review protocols/reports, and ongoing data analysis.
- Coordinate with Regulatory Affairs/Quality Assurance/Supply Chain to ensure project deliverables adhere to company standards.
- Work with teams to proactively identify roadblocks, risks, or issues and drive towards collaborative, goal-oriented solutions to maintain project progress.
- Participate in evaluation of potential projects, CMOs, CROs as needed.
- Communicate with stakeholders (internal and external) about any relevant information for development or registration batches such as development reports, test methods, specifications, Certificate of analysis, stability documents, etc.
- Provide regular updates to the business and leadership on project status and major risks. Maintain project dashboards and project update meetings.
- Facilitate and execute SOWs/WOs, PO placement, invoices, etc. to enable project activities.
- Develop, maintain, and facilitate project plans to assure timelines are met.
- Present project updates to executive management
- BS/BA in Engineering or Life Sciences
- Minimum 7 years of experience in the pharmaceutical, medical device, or life-sciences industry
- Minimum 5 years of project management experience; Project Management certification (PMP) preferred.
- Industry experience in a quality, technical or marketing role is advantageous.
- Desire to work in a dynamically growing environment with changing circumstances, direction, and strategy.
- Collaborative team player who can also work independently to achieve established goals.
- Strong analytical and problem-solving skills to resolve planning, procurement, and supplier issues.
- Ability to use independent judgment and discretion to deliver against both business expectations and goals.
- Results oriented with a sense of urgency.
- Sound research skills, and a proactive/positive attitude are necessary for success in this role.
- Requires strong experience with use of Microsoft tools.
- Some travel may be required.
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Description
Overview
Manage pharmaceutical projects across the lifecycle from submission to post-launch. Drive the delivery of project scope, resourcing and scheduling through issue resolution and team collaboration.
Key Responsibilities
Qualifications
