Project Manager

 

Summary:

In collaboration with departmental leaders, project leaders and Sr. Management, the Project Manager will be actively engaged in the development and daily management of comprehensive plans that encompass all the organizational activities necessary for drug approval.

Specific activities of the Project Manager include the development of timelines that provide a clear view of the critical path, the identification of potential impediments and strategic alternatives and leading team discussions to develop and implement solutions so that products are developed, manufactured and proceed through the clinical and regulatory pathways as scheduled. The Project Manager will also facilitate and coordinate activities and objectives and ensure that all project tasks are identified, assigned and tracked.

It is absolutely essential for the Project Manager to have in-depth experience planning and/or managing multi-functional departmental projects in a pharmaceutical environment. It is highly preferred that the Project Manager have experience identifying and planning activities required for submission and approval of an ANDA.

Essential Duties:  

  • Facilitate team approach and departmental integration in order to maximize efficiency of the drug development process.
  • Identification, mediation and resolution of issues.
  • Interface liaison with external partners, customers, vendors, suppliers and contractors.
  • Ability to clearly and concisely articulate capacity constraints in a quantifiable manner and identify alternatives to maintain completion of objectives.
  • Coordinate and develop strategy for product development and approval
  • Ensure that good decision making principles are identified and evaluated resulting in win-win opportunities.
  • Coordinate and balance the needs of key stakeholders within the development and commercial organizations through honest and open communication.
  • Influence and negotiate skillfully through tough situations while maintaining good will and important relationships.
  • Create strong team spirit by communicating a compelling and inspired strategic vision that embraces clear priorities.
  • Take ownership of and be accountable for performance
  • Communicate project status and plans in a clear, concise and transparent manner to all levels of the organization. 

Candidate Attributes:

  • Excellent organizational skills and attention to detail.
  • Superior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organization
  • Familiar with the necessary components of facility qualification and validation activities.
  • Extensive knowledge of cGMP regulations and ICH guidelines.
  • Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners.
  • Ability to work in a lean, action oriented organization and demonstrate a strong work ethic.
  • Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team.
  • Microsoft Project ® expertise.

Minimum Qualifications Required:

Bachelor’s degree in Life Sciences coupled with at least 5 years of pharmaceutical project planning/management experience in a developmental function and an overall in-depth knowledge of the pharmaceutical drug development and commercialization process.