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Director, Project Management - Pharmaceutical Drug Development
Company | Bausch Health Companies Inc. |
Address | Petaluma, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-09-04 |
Posted at | 8 months ago |
Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
- Should be able to manage Phase 4 development or post marketing issues whether CMC, clinical or nonclinical
- Is expected to evaluate new product ideas and thoroughly research it with medical, clinical, CMC, IP and KOL’s as needed
- Will be responsible for project execution and on time delivery of milestones, and managing outside partners and alliances, and facilitate meetings.
- Will effectively drive communication within cross functional teams.
- Will effectively communicate project status to management and provide resolution of project issues.
- Is expected to critically evaluate opportunities involving commercial/licensing/partnership/intellectual property activities related to the project(s); Should be able to provide complete development strategies and budgets as needed
- Should be able to provide leadership and mentorship to development managers as well as core team members
- Is expected to provide solutions to improve efficiency
- In concert with the Core Team, the Project Manager will develop, maintain, and drive the project timelines milestones and track budgets for project. The candidate will lead the review of status of projects at stages gates and when signification deviations occur and update the team accordingly.
- Should have good working knowledge of all areas of development – including CMC, non-clinical, clinical, project management and regulatory functions
- Will be expected to manage all milestone regulatory filings for development programs from pre-IND briefing packages to NDA submission.
- May be involved in overseeing the collaboration activities with external partners in the integration of services, technologies and capabilities.
- Excellent communication skills
- The successful candidate independently documents project issues, agreements and decisions in team minutes in a timely manner required
- 5+ years’ experience in project management, leading multi-disciplinary project teams through the various phases of product development is preferred
- Experience with co-development partners/arrangement and/or international experience preferred
- The successful candidate proactively identifies and acts to resolve project issues, including those related to timing, resources and funding, to prevent delays in project milestones required
- Proficiency of regulatory development requirements in the US along with working knowledge for the RoW development
- Bachelors degree with 10+ years' experience or a Masters degree with 8+ years experience' in Life Sciences or Engineering discipline in pharmaceutical R&D environment
- Ability to represent project teams at management meetings
- Required to be knowledgeable in pharmaceutical product development and the interdependencies of specific development activities.
- Proficiency of regulatory development requirements in the US with a working knowledge for RoW development
- Expertise in the application of project management software (e.g. MS Project) and in the use of the project/portfolio management systems required
- Proven negotiation, issue resolution and team building skills required
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