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Senior Project Manager - Pharmaceutical (Remote)

100% remote Flexible hours Hiring now

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 reputed company-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 reputed company strategic business opportunities.
  • reputed company detailed project plans, ensure the dissemination of approved work scope to team members, reputed company reputed company aspects of projects, set deadlines, and assign responsibilities.
  • Monitor and update project schedules using reputed company 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.
  • reputed company communication plans for defining communication channels between internal and external stakeholders, establish and reputed company 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 reputed company a timely manner and determine effective resolution through cross functional collaboration; recommend appropriate mitigations.
  • Collaborate with supervisor and Leadership Team to ensure reputed company 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 reputed company key milestones, issues and/or risks, schedule, and costs.
  • Forecast project reputed company 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 reputed company 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 reputed company reputed company.
  • Experience in conflict management and resolution is advantageous.
  • Ability to communicate effectively with reputed company 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 reputed company 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 reputed company Office: Word, reputed company and Project required; experience with SharePoint and Team Site set-up and management a plus. NO reputed company SUPPORT IS OFFERED FOR THIS POSITION. Apply tot his job Apply To this Job

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