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Job: Project Manager, Pharmaceutical Product Development, FHI 360, Durham, NC

General Information

Job title:
Project Manager, Pharmaceutical Product Development
Job location:
Durham, NC  27701 United States
Requisition code:
Date posted:
Job category:
Research and Development
Clinical Research
Program Management
Employment type:
Full time

Job Description

Project Overview:
FHI 360’s Contraceptive Technology Innovation team leads development and testing of a portfolio of new contraceptive leads 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 pre-clinical and clinical stage contraceptive product development to achieve project goals within schedule, scope, and budget. Responsible for a range of pharmaceutical project management activities to internal project teams and external sponsors and/or funders including contract and budget management, risk management, alliance management, implementation of project management software and tools, process creation/improvement, and regulatory submission management.

Works closely with program/project leadership to manage contraceptive product development project activities across the product development lifecycle 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.

Specific job responsibilities include:
Develops and delivers project workplans, financial and progress reports, training, and presentations to sponsors, funders, management and staff.
Facilitate vendor selection process from vendor identification to execution (including but not limited to CROs, CMOs).
Conduct evaluation visits as needed.
Oversee project finances including but not limited, to developing budget proposals and subcontracts, monitoring expenditures on project and subcontract levels.
Develop integrated product development timelines; maintain and monitor timelines and milestones for the project(s).
Applied Knowledge & Skills:

The Project Manager: Pharmaceutical Product Development will have the following experience and skills:
Drug Development
Budget Management
Grant and Contract Management
Risk Management
Regulatory Submission Management
CMO Management
Project Management Software/Tools
Process Creation/Improvement
People Management
Managing Matrix Teams
Due Diligence
Alliance Management
Business Development
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

Job Requirements

Bachelor’s Degree or its International Equivalent in Chemistry, Pharmaceutical Science, Biochemistry, or related field
Master’s Degree preferred
Project Management (PM) Certification preferred

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
Second language, ideally Chinese, preferred

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 description 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 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

Please click here to continue searching FHI 360's Career Portal.

FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment 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, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.
(Job number: 3844276)
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