Sr. PM will lead and drive projects from development, validation and launch activities for the U.S. or Region as applicable. 

The successful incumbent will use project management methodologies and best practices to deliver projects on time and within budget. The Senior Project Manager 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.  

The Sr. Project Manager candidate has knowledge that supports entering other global markets, i.e., Asia, Europe and other geographies.  

This individual understands and can apply knowledge of US & Global regulatory guidelines and federal regulations governing pharmaceutical drug development with respect to Alvogen’s drug development programs to commercialization. Leads projects to achieve pre and post-approval submissions, while meeting aggressive timelines and adhering to the highest quality standards. The Sr. Project Manager will lead, execute, support, and facilitate confidential information exchange with other Regulatory regions and collaborates with functional groups to plan, author, and lead projects to submission in targeted regions. 

Primary responsibilities include, but not limited to, managing activities leading to the successful execution of the project; establishing Charter, Notes, Project timelines with milestones in collaboration with stakeholders (External CMO, CRO, Quality, R&D Formulation, Analytical, Regulatory Affairs, Supply Chain, etc.); and ensuring accountability of team members for deliverables. Additionally, the Senior Project Manager will communicate across functional and leadership levels manage risks and risk mitigation plans. 

Secondary activities may include 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. Position will include travel.  

The candidate must have experience with multiple dosage forms including, not limited to (Solid-oral, injectables, Inhalants, Semi-solids, liquids, soft gels, transdermal delivery systems, sublingual films etc.) 

ORGANIZATION STRUCTURE  

The Senior Project Manager reports to the Director of Project Management. This position has no direct reports.  

RESPONSIBILITIES  

1. Serve as leader and prime advocate for your projects.  

2. Lead project meetings; mediate, identify risks and resolve conflicts; and drive teams to success. 

3. Issue written agendas in advance of meetings and timely distribution of minutes. 

4. Post meeting minutes within 24 hours of meeting. Including resulting action items between meetings and ensure accountability of team members to complete assigned tasks. 

5. Author and implement Charters, Project timelines etc.  

6. Download from other applications-controlled specification and other product documents that support regional dossier audits, due diligence questions & answers and for final dossier submission in other regions. 

7. Maintain SharePoint and other databases with project status and key project information according to structure. 

8. Liaison with clients, partners and suppliers.  

9. Interface with all levels of management and ensure alignment throughout the organization. 

10. Acts as liaison between company and regional Regulatory functions and clients. 

11. Be a model of superb organization, excellent timeliness and tireless follow up.

QUALIFICATIONS  

1. BA or BS degree in science or engineering from accredited college or university. (MBA and PMP a plus) 

2. Seasoned project management professional with a minimum of 5 years’ experience in the pharmaceutical industry, preferably w/ NDA 505(b)(2), ANDA generics and Global expansion. 

3. Experience in cGMP pharmaceutical R&D and / or Manufacturing Operations a plus. 

4. Experience with working with third party CMOs on validation and project launches. 

5. Understanding of injectable equipment and processes. Familiarity with other dosage forms a plus. 

6. Strong analytical skills and business acumen specific to operational activities and product launches in generics. 

7. Cross functional collaboration skills with the ability to network with different functional areas and integrate cross functional deliverables. 

8. Proficiency in MS Office, MS Project, QUMAS, SAP and SharePoint. 

9. Strong oral interpersonal and written communications skills. 

10. Strong ability to prioritize, multi-task and work in a very fast paced and dynamic environment. 

11. Strong critical and logical thinker with ability to analyze problems. 

12. Highly organized and self-motivated.  

13. Able to exercise sound judgement. Demonstrated ability to make sound decisions on regulatory activities, strategies and work outputs. 

14. Unyielding predisposition to detail, accuracy and clarity. 

GMP DECISION-MAKING AUTHORITY  

No GMP Decision Making  

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