Job Description
Job Overview: Responsible for the overall management, direction, coordination, implementation, execution, control, and completion of specific projects ensuring consistency with company strategy, commitments, and goals.
Responsibilities: - Act as a liaison between internal'/external stakeholders.
- Track client projects.
- Identify potential project pitfalls and coordinate with operations to apply effective strategies to overcome.
- Maintain and update project timeline to ensure client objectives are met.
- Chair project team meetings.
- Oversee and partner with the Project Managers to prepare meeting minutes.
- Manage billing milestones, capture subsequent additions to original work scope and relay information to the Business Manager/ Account Manager.
- Ensure on-time delivery of project milestones.
- Attend external meetings as required.
- Manage client expectations and develop working relationships with client that foster business.
- Provide weekly updates to clients on project progress unless otherwise captured in meeting minutes from teleconference.
- Cost/Budget Analysis
- Generate KPI/ reports.
- Optimize continuous improvement.
- Negotiate with vendors/external service provider.
- Manage ANDA/NDA drug development life cycle including R&D, deficiency, optimizing processes.
- Perform other duties and assist in special projects as assigned/required.
Qualifications: - BS in chemistry, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
- Four (4) or more years of related experience, including some in the health/pharma industry.
- Project Management Professional certification (PMP) is desired.
- Demonstrate the ability to read and interpret documents such as safety rules, FDA guidelines and analytical procedures.
- Demonstrate the ability to write routine reports and correspondence. Ability to speak effectively before groups.
- Demonstrate conflict management ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exist.
- Demonstrated experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff.
- Demonstrate strong experience with project and people management.
- Demonstrate the ability to administer personnel performance evaluations.
- Demonstrate the ability to write and understand technical information and produce detailed reports.
- Demonstrates good leadership skills and the ability to establish and maintain good working relationships with other departments, including vendors, colleagues, and subordinates.
- Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
- Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
- Must be able to comprehend and follow all applicable SOPs.
- Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
- Demonstrate solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
- Good understanding of cGMPs, industry, and regulatory standards and guidelines.
- Demonstrate solid understanding/use of Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
- Demonstrate the ability to portray the appropriate level of integrity and professionalism.
- Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
- Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
- Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
- Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results-oriented and efficient.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
- Demonstrate the ability to work well in a cross-functional team environment.
- Must communicate fluently in English and have legible handwriting.
Physical Demands: - Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
- Ability to lift up to 40 pounds on occasion.
- Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
Job Tags
Local area, Shift work