Senior Project Manager - Pharmaceutical (Remote)

THIS IS NOT AN IT OR SYSTEMS POSITION. CANDIDATES MUST HAVE DRUG DEVELOPMENT KNOWLEDGE/EXPERIENCE Essential Duties & Responsibilities • Collaborate with internal and external stakeholders and ensure projects remain in scope and meet budgetary scheduling and quality requirements. • Primary point-of-contact for client programs assigned; responsible for building and maintaining quality relationships with key stakeholders resulting in valued and trusted relationships, client satisfaction and continued strategic business opportunities. • Develop detailed project plans, ensure the dissemination of approved work scope to team members, oversee all aspects of projects, set deadlines, and assign responsibilities. • Monitor and update project schedules using Microsoft Project, produce dashboards, and assess project health. • Provide project management leadership to cross-functional Project Teams conducting project scopes of work. • Responsible for client contract adherence; anticipate and proactively manage changes in project scope. • Responsible for purchase order management, holding project team accountable for agreed upon deliverables, and escalating issues such as scope creep or roadblocks appropriately. • Develop communication plans for defining communication channels between internal and external stakeholders, establish and lead regularly scheduled project status meetings, and communicate/escalate as needed in response to issues as they arise during project execution. • Conduct risk assessment and identify key project challenges and issues within a timely manner and determine effective resolution through cross functional collaboration; recommend appropriate mitigations. • Collaborate with supervisor and Leadership Team to ensure all activities defined herein, meet or exceed clients' expectations, including the establishment and monitoring of project budgets. • Provide regular program status reports to clients and Leadership Team that shall highlight key milestones, issues and/or risks, schedule, and costs. • Forecast project revenue on a monthly, quarterly and annual basis. • Will be responsible for multiple programs and/or projects at any given time. • Work with the project team to formulate recommendations for value added services based on project objectives and regulatory requirements. • Collaborate and communicate with Pharmaceutics/Operations to ensure 1) appropriate material procurement activities occur and urgency is understood, 2) determine plan for excess and obsolete material disposition • Collaborate and communicate with Operations to ensure appropriate generation of GMP documentation including batch records, specifications, etc. • Collaborate and communicate with the Analytical Laboratory to ensure necessary client testing is developed, validated/verified, specifications are generated and product is tested per a mutually-defined timeline. • Assist in training and act as a mentor to expanding project management team. • May have other duties and responsibilities as required. Competencies • Understand drug formulation, analytical method development, stability, and bulk drug manufacturing practices • Skilled in client relationship management. • Positive attitude, self-motivator, strong attention to detail, excellent organizational and project management skills required. • Strong interpersonal skills with the ability to negotiate with various stakeholders to reach consensus. • Experience in conflict management and resolution is advantageous. • Ability to communicate effectively with all levels of employees and management. • Familiar with global drug development processes and clinical supplies life cycle • Knowledge of GCPs and clinical management would be advantageous Qualifications • Bachelor's degree in the life sciences, engineering, business and/or related discipline required • At least five (5) years project management in pharmaceutical industry required, CDMO experience highly preferred • Knowledge and experience of U.S. FDA Regulation 21 CFR Part 210, 211 and ISO 9001 is preferred. Advanced in Microsoft Office: Word, Excel and Project required; experience with SharePoint and Team Site set-up and management a plus. NO VISA SUPPORT IS OFFERED FOR THIS POSITION. Apply tot his job

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