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
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
Qualifications
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.