This is an exciting opportunity to join a team of highly successful Irish pharmaceutical industry executives in a venture focused on US / ROW specialty markets.
The company is led by a management team who have a long and highly successful track record of success in establishing and building entrepreneurial driven pharmaceutical businesses. The company markets a portfolio of innovative and successful prescription products through its commercial infrastructure in both the USA and ROW.
Reporting to the head of Technical Operations, the Sr Project Manager will coordinate the day to day project management focused activities in support of advancing multiple Development and Technical Services projects from the Dublin office. The position will provide project leadership, organization and management to the project delivery teams and subcontractors. Will build and maintain effective and collaborative relationships with peers, executive management, and external customers.
- Coordinate a series of Development and Technical Services projects which may include Regulatory, CMC-Drug and CMC-Device developmental activities.
- Coordinate project team and provide overall leadership and management of all aspects of the teams and projects including subcontractor management.
- Works in partnership with in-house and CMO teams for the delivery of all pipeline projects and on-going management of commercial / technical projects.
- Establish project core and sub-teams; facilitate discussions, team member conflicts and provide guidance/ direction on key critical project issues.
- Build effective and collaborative relationships with peers and executive management, as well as manage and communicate project scope changes, issues and risks.
- Establish, maintain and serve as liaison (along with project Technical Lead) with customer, subcontractor counterparts and key internal stakeholders.
- Recognize and resolve fundamental and unanticipated project issues. Where problems arise, can exercise judgment to identify an appropriate course of action for obtaining results. Erroneous decisions may result in critical delay(s) to schedules and/or may jeopardize specific business activities.
- Ability to change the thinking of or gain acceptance of others in sensitive situations.
- Set project strategy, priorities and milestones and lead project team with this vision.
- Establish and maintain project timelines and Integrated Financial Plans.
- Develop, defend and manage project budgets coupled with an ability to manage and evolve as project needs change.
- Regularly present to senior management and other key stakeholders in the form of Product Development or Project Update Presentations.
- Complete company and customer reporting requirements through dashboards and other updating tools.
- Develop and maintain project SharePoint site content
- BS in science, engineering or similar discipline with an advanced degree in science and/or business an advantage.
- Certification in Project Management skills is an advantage.
- Strong written and oral communication skills.
- Project coordination experience required with two or more years in the role of project leadership. Management experience in combination product, device and/or drug development is an advantage.
- General understanding of pharmaceutical/ biotechnology industry.
- Experience with medical devices, combination products, regulatory, quality and manufacturing.
- Experience managing and leading combination product or drug product teams.
- Excellent leadership, interpersonal and communication skills.
- Effective critical thinking and problem-solving skills.
- Strong skills with Microsoft Office software including Visio, Word, Excel and Power Point are required.
- High proficiency using MS Project.
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