Project Manager

  • NY-112, Medford, NY, USA
  • Full-time

Company Description

Our Client is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. 

Job Description

Applicants must have a background working for a Pharmaceutical company.

The Project Manager position is a highly visible individual contributor role that reports to the 6AD of Project Management, R&D, North America. The job duties for this position include but are not limited to the following:

 

· Responsible for end-to-end project leadership and management (scope, cost and time) deliverables for projects.

· In a dual-leadership structure on projects, operate as a Project Leader (PL) along with a project Technical Leader (TL).

· Operate as the primary liaison and project manager on Internal /external partnerships of North America. Responsible for delivery on the projects to agreed and planned scope, time, cost and quality.

· Operate as the single point of contact for internal stakeholders on all aspects of projects. Internal stakeholders include but limited to executive management committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs, regulatory affairs, quality assurance, procurement etc.

· Act as the custodian of the project governance process. Responsible for stage-gate reviews and escalation of topics, as required. Responsible for maintaining a version of project plan for all external partnerships. Responsible for drafting and delivering presentations to executive management.

· In collaboration with commercial, supply chain management and regulatory affairs, responsible for launch planning, launch risk mitigation and launch supply readiness.

· Responsible for collaborating with global stakeholders particularly Integrated Product Development (IPD) and Quality Assurance (QA) to incorporate technical best practices including QbD principles in all technical studies.

· Participate and/or lead technical due diligences on projects where actively engaged with a potential partner to in-license or co-develop a product.

· Maintain a pro-active, informed and nimble approach for all aspects that may affect the delivery of the projects to approved plan.

  • Maintaining strategic alignment between the program, organization and stakeholders

· Provide relevant feedback to commercial and portfolio functions on assumptions, risks and market developments leading to development of commercial models.

· Lead and implement a risk-based approach towards assessment of projects, project milestones and stage gate reviews.

· Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to relevant stakeholders.

· Maintain effective and pro-active communication and coordination of activities with multi-functional internal and external stakeholders.

 

EDUCATION AND EXPERIENCE

· US Citizen / Green Card Holder / H1B

Masters in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry, Medicinal Chemistry or Chemical Engineering.

· Project Leadership or Project Management or Alliance Management experience is a must.

· 6 + years of relevant industry work experience is a must.

· Experience with product development process as applied to 505(b)(1) NDA and/or 505(b)(2) NDA and/or BLA product registration pathways is a must.

· Project Management Professional (PMP®) certificate or other relevant project management training is a plus.

· Knowledge of SAP system is plus.

· Prior experience in managing projects with internal and/or external stakeholders (e.g., CROs, CDMOs) is a must.

· Experience with project governance practices is a must.

· Excellent organization skills in a must.

 

PROFESSIONAL COMPETENCIES AND TECHNICAL SKILLS

 

· Must possess excellent communication skills.

· Must have experience with drafting project plans and budgets.

· Must be able to negotiate and communicate across organization reporting lines.

· Must possess strong documentation and technical writing skills. Must be able to apply relevant scientific principles and practices.

· Must be able to work independently under minimal supervision and in a team environment.

· Must be able to exercise appropriate professional judgment on matters of significance.

· Must be proficient in computer skills and software applications such as Microsoft Office tools.

Qualifications

Ph.D.or Masters in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry, Medicinal Chemistry or Chemical Engineering.

· Project Leadership or Project Management or Alliance Management experience is a must.

· 6 + years of relevant industry work experience is a must.

· Experience with product development process as applied to 505(b)(1) NDA and/or 505(b)(2) NDA and/or BLA product registration pathways is a must.

· Project Management Professional (PMP®) certificate or other relevant project management training is a plus.

Additional Information

 

Kindly do not apply if you do not meet minimum requirements.