FHI 360

Project Manager (Pharmaceutical Product Development)

FHI 360

Job Description

FHI 360’s Product Development and Introduction team leads development and testing of a portfolio of new contraceptive technologies with a focus on long-acting methods. The team consists of 30+ contraceptive development professionals with expertise in reproductive biology, gynecology, chemistry, epidemiology, and clinical trial and Project Management. We are currently seeking qualified candidates for the position of: Project Manager, Pharmaceutical Product Development.

Job Summary:

Manages cross-functional teams focused on the preclinical and early clinical stages of contraceptive product development to achieve project goals within schedule, scope, and budget. Responsible for a range of pharmaceutical development project management activities including Contract Management, budget monitoring, stakeholder management, Coordination of grant proposals and project reports, risk management, implementation of project management software and tools, and process creation/improvement.

Specific job responsibilities include:

  • Leads technical discussions and project status meetings with internal project teams, external partners and funders

  • Develops and delivers project workplans, progress reports, and presentations to sponsors, funders, management and staff.

  • Facilitates vendor selection process from vendor identification to execution (including but not limited to CROs, CMOs).

  • Collaborates with Financial Program Managers to develop and monitor budgets.

  • Develop integrated product development timelines; maintains and monitors timelines and milestones for the project(s).

  • Supports and facilitates the development of proposals to secure funds from both government and private funders.

  • Conducts evaluation visits as needed.

Accountabilities:

  • Works closely with program/project leadership to manage contraceptive product development project activities across the product development life cycle with focus on minimizing risk across multiple activities, monitoring budgets and work scope to ensure successful execution of deliverables and completion of project(s).

  • Coordinates a cross-functional team of preclinical and clinical scientists and Project Support staff.

  • Develops and implements best practices and tools in pharmaceutical development project management.

  • Identifies and resolves project issues and implements improvement plans to ensure project stays on schedule and within budget.

  • Coaches, mentors, and manages project teams to ensure quality, efficiency and compliance with project and company standards/policies.

  • Builds, develops, and grows partnerships vital to the success of the project.

Applied Knowledge & Skills:

The Project Manager: Pharmaceutical Product Development will have the following experience and skills:
  • Early Pharmaceutical Product Development

  • Budget Management

  • Grant and Contract Management

  • Risk Management

  • Regulatory Submission Management

  • CMO Management

  • Project Management Software/Tools

  • Process Creation/Improvement

  • Stakeholder Management and Communication

  • Managing Matrix Teams

  • Excellent oral and written communication skills

  • Ability to influence, motivate, and collaborate with others

  • Ability to adapt and resolve problems/issues to bring project to completion

Supervision Given / Received:

  • Manages staff and external project members to achieve goals and vision of project from initiation to completion.

  • May supervise one or more project support staff

  • Will report to a Project Lead or Director

Education:

  • Bachelor’s Degree or its International Equivalent in Chemistry, Pharmaceutical Science, Biochemistry, or related field

  • Master’s Degree preferred

  • Project Management (PM) Certification preferred

Experience:

  • Master’s Degree with minimum 3 years or Bachelor’s degree with 5 years of project management experience within the pharmaceutical industry

  • Background in formulation/chemistry preferred

  • Must be able to read, write and speak fluent English

Typical Physical Demands:

  • Typical office environment. Ability to sit and stand for extended periods of time.

Technology to be Used:

  • Personal Computer, Microsoft Office (i.e. Word, Excel, MS Project/OnePager, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand-held devices.

Travel Requirements:

  • Approximately 20%

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time. FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable Law. FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
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