Project Management Leader - Pharmaceutical Development & Commercialization

Job Type: Full-time
Location: Bethesda, MD/Washington DC metro area (hybrid possibility)
Job Title: Project Management Leader - Pharmaceutical Development & Commercialization
Company Overview:
Pocket Naloxone Corp. (PNC) is a mission-based start-up pharmaceutical company in the Washington DC metro area and is seeking a Project Management Leader with extensive experience in Pharmaceutical Development and manufacturing.
Position Overview:
We are seeking a highly motivated and experienced Project Management Leader to join our team to assist in the coordination and alignment of projects across the spectrum of PNC operations. This position will report to the Chief of Staff / VP of Operations and Administration and will be responsible for managing projects across cross-functional teams to ensure the successful delivery of projects on time, within scope, and on budget. The functional areas will include technical operations and manufacturing, business operations, product development, regulatory support, and commercialization. The Project Management Leader will develop and provide regular reports for the executive team to ensure transparency and efficient identification of delays and barriers in project plans and target deliverables and milestones. Success in this role will mean achieving effective project trackability across corporate functions, understanding and planning for interdependencies, forming effective relationships with stakeholders, and ensuring that organizational leadership remains informed of the enterprise project environment.
Responsibilities:

• Lead project planning and execution activities, including defining project scope, timelines, budgets, and resource requirements.
• Develop and maintain project plans, track progress, and ensure timely completion of project milestones.
• Manage project risks and issues and escalate as necessary to senior management.
• Communicate project status updates and progress reports to stakeholders, including senior management, project team members, and external partners.
• Facilitate cross-functional team meetings, including project kick-off meetings, regular status meetings, and post-project reviews.
• Coordinate activities with external partners.
• Ensure adherence to regulatory requirements, including FDA regulations, GMP, and other relevant guidelines.
• Identify areas for process improvement and work with stakeholders to implement changes.
• Foster a culture of continuous improvement, collaboration, and teamwork.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Qualifications and Skills:

• Bachelor's degree in a relevant field such as health administration, business, pharmacology, biology, chemistry, or engineering.
• Minimum of 5 years of experience in Project Management in the pharmacology industry leading projects across the spectrum of Pharmaceutical Development and manufacturing.
• Strong understanding of Pharmaceutical Development, technical operations, and quality systems within the pharmaceutical industry.
• Experience managing projects across cross-functional teams, including research and development, quality assurance, regulatory affairs, manufacturing, supply chain and commercial operations.
• Familiarity with regulatory requirements and guidelines, such as FDA regulations, GMP, and ICH guidelines desired.
• Excellent organizational and communication skills, with the ability to effectively communicate complex information to both technical and non-technical stakeholders.
• Strong leadership skills, with the ability to motivate and manage teams to achieve project goals.
• Ability to work effectively in a fast-paced, dynamic environment with changing priorities and tight deadlines.
• Ability to understand, communicate, manage, and work with multiple stakeholders with different functional expertise.
• Demonstrated strong organizational and Project Management skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

• Ability to be flexible and adaptable in a startup environment and a desire to be part of building the organization’s infrastructure and supporting its expansion and growth.
• PMP and Lean Six Sigma certifications desired.

Travel:
Ability to travel as needed.
Other Information and Benefits:
Benefits include health, vision and dental insurance, 401k plan with a company funded 5% match, and FSA. The Company also provides employer funded life/ADD and short- and long-term disability insurance to employees. In addition to 21 days of PTO, full-time employees also receive a generous number of paid company holidays per year (for 2024 PNC is allocating 19 paid holidays).
PNC is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
*WE DO NOT ACCEPT CANDIDATES FROM OUTSIDE SEARCH FIRMS AND RECRUITERS PLEASE*
 

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