Program Manager

Corium Innovations-posted 4 days ago
Full-time • Mid Level
Grand Rapids, MI
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C Corium Innovations is seeking a Program Manager to manage program deliverables, timelines and budgets for internal and external development, commercial, and continuous improvement programs and projects in the pharmaceutical industry. This is a unique opportunity to take on a key role with a broad range of responsibilities. Your most Innovative career move is here! At Corium Innovations, we’ve led the way in innovating drug delivery technologies for millions of patients whose GI systems just can’t tolerate pills, who can’t remember to take their meds as directed, or who have needle-phobia. This is only the beginning! There’s so much more to deliver, and we need YOU to do it! Our Purpose is to create, develop and manufacture innovative healthcare products for partners that deliver superior value to patients. Our Goal is to be the best-in-class specialty CDMO through the use of innovative technologies and superior execution. Our Company Values are core to our positive and people-centric culture which inspires all of us to come to work every day on behalf of our people, our partners, our customers, and our patients. Through our four core values, we put people first and create opportunities to make each day better than the last. Celebrate Individuals: We ’ re looking for talent who will celebrate the uniqueness of each of our team members by encouraging everyone to bring their authentic self to work. Successful Together: We believe we ’ re better together, so we prioritize teamwork as we work to achieve our shared vision knowing each one of us has an important role to play. Embrace Innovation: We embrace new challenges and opportunities while encouraging creative thinking and innovative solutions to best meet the needs of our people and our partners. Pride in Ownership: We take pride in owning our progress and successes, feeling empowered to pursue our growth to reach our full potential. And we hope you will too!

  • Develops, maintains and owns Corium Innovations project management system and procedures, including the Microsoft Dynamics D365 project module and the Product Development Process while also managing programs to meet PDP requirements which ensures compliance to combination product regulations for development and commercial programs.
  • Participates as a core member of the Corium Innovations Operations Leadership Team, which is responsible for oversight of all Corium Innovations site operations.
  • Develops project scope, budgets and timelines with the input, support and alignment of cross-functional team members and leadership. Tracks, identifies, and resolves scope changes as well as communicates these changes to internal and external partners and ensures appropriate leadership approvals. Also manages CRO’s and Clinical Trial Reports Database.
  • Partners directly with COO, CBO and CTO in reacting to new RFPs and subsequently developing new business proposals, while also managing site visits and due diligence for new potential customers.
  • Coordinates internal and external project meetings, including agendas and minutes including action items and follow up as necessary.
  • Provides project updates to internal management and partners.
  • Participates in the strategic planning for long range projects, including business impact.
  • Reviews project hours and out-of-pocket expenses monthly to ensure accurate time reporting and budget adherence. Works with management to address labor/expense overage.
  • Forecasts labor hours, using analytical tools, to understand potential labor overages.
  • Partners with the Finance Department with development and implementation of tools for project budgeting; leads month-end billing and authorization of invoices as they pertain to project deliverables and milestones.
  • Mentors, guides and provides oversight to less senior project/program managers as necessary.
  • Responsible for long range financial planning for multiple projects or programs, including prediction of cash flow on a fiscal year (or longer) basis.
  • Partners with COO in ownership of the project management department budget.
  • Supports the cross-functional project teams in the structured and timely submission of regulatory applications and supplements.
  • Supports partner, ISO, or regulatory audits / inspections to ensure team inspection readiness.
  • Coordinates the scheduling, agenda, and minutes for Quarterly Business Reviews (QBRs)with partners as appropriate. Participates in QBR meetings, including providing executive level updates and presenting information to gain agreement on changes in scope, status, or direction of a project.
  • Responsible for managing multiple projects or programs while objectively assessing progress, likelihood of success and alignment with corporate objectives. In doing so, makes recommendations for progression or remediation of programs and projects.
  • Bachelor of Science Degree; MS/MBA preferred.
  • PMP or other project management certification preferred; pharma preferred
  • 10+ years related experience, including at least 3 years managing pharmaceutical programs.
  • Microsoft Word, Excel, Powerpoint, Outlook and Project.
  • Strong operational knowledge of the product development life cycle with regards to new and generic drugs.
  • Must be able to interact with individuals at all levels of the organization as well as external strategic partners and regulatory authorities.
  • Must be able to maintain strict confidentiality regarding internal and external information.
  • Must be detail-oriented and able to provide self-direction.
  • Must be able to provide coaching and constructive criticism to project management
  • Strategic analytical thinker with strong business acumen.
  • Proven ability to make sound decisions about allocation of resources and managing priorities.
  • Demonstrated team leadership capabilities with a proven track record of meeting objectives.
  • Ability to plan over a 12-to-24-month time span.
  • Excellent interpersonal and communication skills.
  • Strong team player.
  • Highly competitive benefits program including medical, dental, vision, flexible spending accounts, life insurance, disability insurance, and employee assistance program.
  • 401(k) retirement savings account with a company match and immediate vesting.
  • 12 paid holidays.
  • Competitive paid vacation plan plus ~1 additional week of paid time off for our annual holiday shutdown.
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