Newark Metro Area, NJ
This position will support the Biologics CMC Program Leadership function and Biologics CMC Project Teams. The Project Manager will be responsible for implementing a knowledge management system to support multiple biologics CMC programs. He/she will work with the Biologics CMC Team Leads, subject matter experts, and CMC Technical Writing Lead to develop and implement an effective electronic knowledge management system for all the biologics development programs in company s portfolio. The Project Manager will also provide support for the development and implementation of electronic systems to manage CMC project information. This role requires the ability to develop and maintain strong collaborative and cooperative working relationships with team members across different functions and at different levels within the organization.
The roles and responsibilities include, but are not limited to, the following:
- With input from the Head of Biologics CMC Program Leadership, Technical Writing Lead, team leads, and team members, support the development and implementation of an electronic knowledge management system for biologics CMC documents.
- Work closely with IT, team members, and subject matter experts, providing guidance and support on how to effectively deploy the knowledge management system and help ensure timely transfer and maintenance of content.
- Advise content owners and CMC project teams on content management processes and on optimal delivery of their content.
- Interface with team members to drive adoption processes, identify barriers for implementation, and suggest ways of overcoming such barriers.
- Manage content and develop governance processes to ensure that information is properly stored and tagged across all line functions and development programs.
- Proactively identify knowledge gaps and work with the teams and team leaders to develop mitigation plans.
- Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving.
- Strong project management skills with experience in organizing, prioritizing, planning, and executing multiple medium scale projects and programs from definition through implementation and adoption.
- Experience in pharmaceutical development, including broad knowledge of the drug development process. Biologics development experience strongly preferred.
- Ability to meet established deadlines; a self-starter capable of working independently and as a team player.
- Demonstrated ability to identify opportunities for better alignment, enhanced efficiency, and process improvements.
- Must be able to interact and communicate effectively at all levels of the organization.
- Must be competent in Project Management tools and methodologies.
- Excellent organizational and time management skills.
- Bachelor s degree with a minimum of 7 years of experience at least 5 years in Pharmaceutical Development and 2 years in Project Management or equivalent. PMP certification desirable