SUMMARY OF POSITION
The Sr Manager/Associate Director, Project Management will lead cross functional project teams, including internal and third-party representatives, to drive development, validation and launch activities for the U.S. Generics and 505b2 portfolio. The successful incumbent will use project management methodologies and best practices to deliver projects on time and within budget. The incumbent will be working in a fast paced and dynamic team environment handling a varied portfolio of high visibility projects with many stakeholders and sometimes competing priorities.
Primary responsibilities include, but not limited to, managing activities leading to the successful execution of the project; establishing project plans with milestones and deliverables in collaboration with stakeholders (CMO, R&D, Regulatory Affairs, Supply Chain, etc.); and ensuring accountability of team members for these deliverables. Additionally, the Associate Director will communicate across functional and leadership levels to inform project status and risks, as well as elevate issues, present recommendations and implement modifications to project plans. Position will include some travel.
In addition, responsibilities will also include the supervision of Project Managers / Senior Project Managers including performance management and project assignments.
Secondary activities may include cross functional / cross project assignments in the R&D arena, along with departmental initiatives and infra-structure build to ensure that project management best practices are being employed across projects.
The candidate must have experience with diverse dosage forms that include but not limited to: solid oral, semi-solids, soft gels capsules, transdermal delivery systems, liquids, sublingual films, injectables.
The Sr Manager/Associate Director, Project Management reports to the Senior Director of Project Management. The position has 1-2 direct reports
- Direct supervision of Project Managers / Senior Project Managers
- Serve as leader and prime advocate for your projects.
- Lead issue oriented project meetings; mediate and resolve conflicts; and drive teams to success.
- Issue written agendas in advance of meetings and timely distribution of minutes.
- Follow-up on action items between team meetings and ensure accountability of team members.
- Develop and implement project plans.
- Maintain SharePoint and other databases with project status and key project information.
- Liaison with third party partners and suppliers.
- Interface with all levels of management and ensure alignment throughout the organization.
- Identify project/portfolio risks, prepare mitigation and contingency plans, and escalate when appropriate.
- BA or BS degree in science from accredited college or university, with a minimum of 10 years’ experience in the generics pharmaceutical industry, with at least 5 years in Project Management
- Experience in cGMP pharmaceutical R&D and / or Manufacturing Operations a plus.
- Certification: PMP certification is a plus
- Experience with working with third party CMOs on development and product launches.
- Experience with ANDA drug development.
- Strong analytical skills and business acumen specific to operational activities and product launches in generics.
- Cross functional collaboration skills with the ability to network with different functional areas and integrate cross functional deliverables.
- Proficiency in MS Office, MS Project, and SharePoint.
- Strong oral interpersonal and written communications skills.
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