Project Manager Associate (539) - BioSpace : Job Details

Job DetailsAbout Civica:Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. Race to the bottom pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results. Who suffers most? Patients. Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been Do What Is in the Best Interest of Patients. Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.Learn more about Civica's plans and progress at www.civicarx.org Job DescriptionThe Project Management associate supports project management across the Petersburg site for both internal and external customers. This role involves coordinating project planning, execution, and monitoring, as well as contributing to process optimization and improvement activities. Knowledge of project management is required to be successful in this role. This role requires meticulous attention to detail, strong organizational skills, and the ability to work effectively in a fast-paced regulated industry. The Petersburg, VA site is Civica's new fill-finish facility dedicated to manufacturing and supplying essential generic sterile injectable medications.Essential Duties and Responsibilities:

• Develop project plans and timelines. Coordinate tasks and resources to ensure timely and successful project delivery.
• Track project progress and prepare status reports for stakeholders. Identify potential risks and issues and propose solutions.
• Create and manage project dashboards for external customers. Ensure dashboards communicate project progress, potential risks and changes to the project schedule.
• Support external customer project meetings.
• Manage complex tasks lists for compliance and inspection ready deliverables. Inform stakeholders of progress and risks for readiness activities.
• Manage the site integrated project schedule.
• Support operational excellence and workforce development activities aimed to enhance and improve processes across the site.
• Manage project-related meetings, document meeting minutes, decisions, and action items.
• Perform office management tasks as assigned.

Basic Qualifications and Capabilities:

• Bachelor's degree and 3+ years of pharmaceutical industry experience is required.
• Understanding of pharmaceutical manufacturing processes and facilities.
• Experience working in cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges.
• Advanced computer skills with working knowledge of MS Project, Office, Word, Excel, PowerPoint, etc.
• Excellent oral and written communication skills, including presentations.

Preferred Experience:

• Start-up experience preferred.