Program & Project Management Services
Helping Pharmaceutical, Medical Device, and Biotechnology companies successfully deliver their complex projects.
Program & Project Management Services
We understand that you are constantly faced with complex projects with tight timelines, finding or freeing up resources to meet those deadlines, and are often dealing with trying to balance your daily work with yet another urgent initiative or critical pipeline project.
ProPharma’s Program & Project Management offering provides the right resource or solution for the right project at the right time. Our project managers seamlessly join teams and successfully implement projects, drug development programs, and other transformational initiatives within pharmaceutical, biotech, medical devices, and diagnostics companies. Our practitioners share a winning approach that blends insights from their subject matter expertise, prior project successes/lessons learned, peer learnings, and fit-for-purpose project design.
Streamline Project Success with Expert Project & Program Management
Successfully Complete Complex Projects
Our proven expertise in project management helps leaders like you prioritize effectively, ensuring your projects get done efficiently and on schedule.Successfully Complete Complex Projects
Our proven expertise in project management helps leaders like you prioritize effectively, ensuring your projects get done efficiently and on schedule. Read LessTackle Tight Timelines
We help leaders prioritize effectively, ensuring projects get done efficiently and on schedule.
Tackle Tight Timelines
We help leaders prioritize effectively, ensuring projects get done efficiently and on schedule.
Read LessAlleviate Resource Burnout
We remove the burden on your staff, allowing them to focus on their core responsibilities without being overwhelmed by project work.Alleviate Resource Burnout
We remove the burden on your staff, allowing them to focus on their core responsibilities without being overwhelmed by project work. Read LessEliminate Scope Creep
Say farewell to scope creep and incomplete projects with our strategic management approach that ensures projects reach completion without unnecessary delays.Eliminate Scope Creep
Say farewell to scope creep and incomplete projects with our strategic management approach that ensures projects reach completion without unnecessary delays. Read LessFind Balance Across Daily Work and Critical Projects
We'll help you balance your daily work when urgent initiatives or critical pipeline projects arise.
Find Balance Across Daily Work and Critical Projects
We'll help you balance your daily work when urgent initiatives or critical pipeline projects arise.
Read LessImprove Visibility Into Key Projects
Gain clarity and insight into your projects with our comprehensive project visibility solutions, empowering informed decision-making across your organization.
Improve Visibility Into Key Projects
Gain clarity and insight into your projects with our comprehensive project visibility solutions, empowering informed decision-making across your organization.
Read LessWhat Makes ProPharma Different?
Most Pharmaceutical, Medical Device, and Biotech companies struggle to execute or complete complex projects. At ProPharma, our deeply experienced professionals partner with client leaders to get their projects done right and allow them to focus on what they do best.
ProPharma's professionals have 10+ years of life sciences project management experience and are a mix of former Big 4 consulting, life sciences organization, or legacy ProPharma and have built a strong project management skill set either from those experiences, industry certifications (e.g., PMP, Lean Six Sigma, Prosci, Agile), and/or advanced degrees (e.g., MBA, Ph.D., MS).
We believe that you deserve project management leadership and expertise so that you can focus on your core job responsibilities. You ought to have better visibility among all projects so that you can eliminate stress, frustrations, and confusion across your organization. And you shouldn’t go it alone.
Our Project Managers Lead Your Projects to Success
We understand how overwhelming it is to keep a project on track with all of your other responsibilities, which is why we have helped hundreds of companies over the last 25 years achieve the results they’re looking for. Our certified professionals deliver projects or your behalf, we set-up and establish project management offices (PMOs) or we provide companies with the training, methodologies and tools they need to empower team members with great project management strategies that lead them to success.
With the help of our deeply experienced professionals you will:
- Get better visibility into your projects so that you can properly prioritize company resources to the most mission-critical projects.
- See your team chemistry and morale improve because projects start and end. And,
- Apply best practice project management methodologies across your entire organization.
Our certified professionals deliver projects or your behalf, we set-up and establish project management offices (PMOs) or we provide companies with the training, methodologies and tools they need to empower team members with great project management strategies that lead them to success.
ProPharma has the Experience You Require
Our Project Managers are capable of effectively working across the life sciences verticals, but we have significant expertise in:
- Capital/Site Facility Build Projects
- Clinical Development
- Early and Late-Stage Drug Development
- Global Medical Affairs
- Manufacturing
- Pharmacovigilance
- Pre-Approval Inspections (PAI) Readiness
- Product Development – Pharmaceutical, Biotechnology, Medical Device and Diagnostics
- Quality Assurance – R&D and Manufacturing
- Technology Transfer
We Specialize in These Types of Challenges
- Build out of a new manufacturing facility
- Identifying and staffing a skilled project manager to support your project needs
- Assessing and optimizing your Project Management Office – PMO
- Providing Project Management Outsourcing support for your function or department
- Providing program management support for early- or late-stage drug development programs
- Providing project management support for pre-approval inspection readiness and regulatory filings
- Overseeing remediation efforts for device, diagnostic, or drug inspections and audits
- Driving regulatory readiness for new regional/local device, diagnostic, or drug regulations
- Driving project management activities for post-merger integrations
ProPharma Offers the Project Management Services You Need
To ensure success, we identify and staff a skilled project manager to support your project needs across pharmaceutical, devices, or combination projects. We support process optimization, organizational initiatives, and technical implementations. Below are examples of our P&PM service offerings:
Drug Development Project Management
We can provide program management support for your early or late-stage drug development programs. Our PMs have expertise in either or both stages of drug development and as requested, will have specialization in therapeutic/disease areas to successfully drive your drug development programs.
Post-Merger Integration
We understand that when your organization makes a significant investment in acquiring a new organization, excellence of post-merger integration execution is critical. But, for a Quality Assurance (QA) organization, there is an added complexity as both legacy organizations must execute ongoing activities and remain in compliance. It is not sustainable nor is it advisable to have two actively ongoing quality systems, long-term. This places the acquiring company with the difficult task of maintaining compliance across both systems and addressing potentially unnecessary cost, process, technology, and organizational redundancies.
ProPharma is deeply skilled in not only Post-Merger Integration but also Quality Assurance processes and technology. The latter is an uncommon Project Management Institute (PMI) skill set and is extremely important in being able to effectively drive your A groups to the desired future state. Our methodology and expertise in executing these activities can complement or drive your integration activities so you can realize integration success.
Regulatory Readiness
Drive regulatory readiness projects for new or updated regional/local device, diagnostic, or drug regulations. As we did for EU MDR, we set-up the PMO, identify and staff PM need, and partner with your organization to successful prepare you for the regulatory requirements.
Audits & Inspections
Our project managers oversee remediation efforts for device, diagnostic, or drug inspections and audits. These efforts typically have several activities which must occur within a specific timeframe. We can help support your goal to achieve compliance by providing a PM to plan, oversee, and execute the effort provide key client stakeholders aware of project progress.
Process Optimization & Organizational Change Management
We understand that throughout the R&D lifecycle, you are faced with multiple challenges such as addressing a process that is not efficient, looking for productivity opportunities, or developing a brand new process. ProPharma’s process optimization approach is collaborative in that we work with you to understand and address your process challenges while using a methodology rooted in lean six sigma and other industry leading process optimization techniques. Our experts will help you optimize your processes at any point in the R&D and Commercialization lifecycle.
To ensure that the updated or new process or project is successful, we integrate OCM processes based on PROSCI methodology to ensure that change impacts have been identified, assessed, and included in the solution, the appropriate stakeholders are aligned, communications and training have been developed/rolled out, and the organization has been sufficiently trained on the change(s). These steps will help to ensure these changes are sustained, post-completion of the project activities.
Specialized PM Services
We provide specialized Project Management services such as:
- Project Management Outsourcing support for your function or department. We drive all aspects of the process from intake, staffing the PMs, providing ongoing updates of project progress, and assigning of the projects.
- Project Recovery to save projects that need urgent, turn-around support and achieve desired project objectives.
- PMO Diagnostic/Health Check in which we assess and optimize your Project Management Office or your suite of projects. Includes PMO software dentification, tools, and roll-out.
- PM Training to upskill your internal resources executing projects.
- PM Mentorship to partner with your internal Project Management resources to help guide and enhance their ability to successfully deliver projects.
- Operational Excellence & Innovation to pursue those projects looking to optimize processes or pursue innovative, challenging projects.
Custom Solutions for Complex Needs
Schedule a call with one of our experts today and tell us about what keeps you up at night. Why? Because you will continue to spend too much time, too much energy and too many resources on projects that never get done until you partner with someone who will get them done right.
Program & Project Management Experts
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Rob Turner
Senior Vice President, R&D Life Sciences Consulting
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Bram Lardee
Senior Director, Product LifeCycle Management
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Kyle Nordstrom
Vice President, Compliance & Quality Assurance
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Simona Mills
Director, Product Lifecycle Management
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Bob Beall
Vice President, Quality and Compliance
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Deb Bartel
Vice President of Quality Assurance
Rob Turner
Bram Lardee
Kyle Nordstrom
Simona Mills
Bob Beall
Deb Bartel
Program & Project Management Articles
November 21, 2024
Breaking the Chains of Project Management Dysfunction
Right now, you are sitting in front of your computer and wondering how, based on current project status, you will achieve your remaining project goals for the year or achieve those planned for the...
May 28, 2024
A Guide to Solving Complex Life Sciences Challenges
Life sciences organizations are consistently inundated with decisions and challenges of varying scale. These can occur anywhere during the life sciences value chain, under any treatment modality...
Agile Use in Non-Software Project
This whitepaper from ProPharma discusses how leaders in the pharmaceutical and medical device industries can use Agile development methods on their non-software related projects. Learn more about...
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
News & Insights
December 19, 2024
WHO Issues Guidance on Antibiotic Pollution Control
WHO issues guidance to control antibiotic pollution from manufacturing, addressing environmental and global health impacts of antimicrobial resistance.
December 18, 2024
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
Explore FDA's recommendations on follow-up testing for Ames-positive drugs to support first-in-human clinical trials. Learn how to navigate FDA regulations and ensuring successful product development.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 24, 2024
ProPharma Honored in the 2024 Clinical Trials Excellence Awards
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
June 10, 2022
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
News & Insights
December 18, 2024
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
Explore FDA's recommendations on follow-up testing for Ames-positive drugs to support first-in-human clinical trials. Learn how to navigate FDA regulations and ensuring successful product development.