1 Antibody Way Oceanside, CA 92056
Bayside Solutions is seeking a Project Manager to be part of our client’ s team in Oceanside, Ca. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Provide project management support to TRTs at any stage of the drug development lifecycle (i.e. early or late stage development, marketing authorization or post-launch marketed phases). Provide support of PTR Strategic Focus Areas and cross-organizational initiatives
- Coordinate and facilitate TRT meetings and all aspects of program information management ensuring robust documentation and communications.
- Partner with TRLs and teams, facilitating team interactions and mobilizing teams to deliver successfully on the agreed objectives.
- Execute project management activities to support products for global market applications and product life-cycle activities.
- Support issue-specific multi-product impacting regulatory projects to ensure alignment of regulatory strategy and compliance across the Biologics and Small Molecule platforms.
- Ensure regular and meaningful project communications, including dashboards, reports and metrics, to enable timely information and analyses to key stakeholders and decision makers.
- Ensure product information flows between TRT members to ensure transparency, informed decision making, and optimal alignment of all technical regulatory deliverables.
- Maintain linkage between TRT and TDT or TPT ensuring alignment of assumptions and communications at all times.
- Facilitate regulatory program risk assessment and align with TPM and TDT processes. Develop, execute and report on risk mitigation or issue resolution activities.
- Proactively monitor timelines, submission process KPIs, critical path and resources for assigned products using appropriate tools, project management principles and practices. Monitor timeline deviations from baseline and KPIs and closely collaborate with TRLs and Submissions Leads to keep submissions on track. Assist with driving data compliance and accuracy across the organization.
- Provide support to PPM and PTR management on major departmental and cross-functional initiatives including Strategic Focus Areas (SFAs).
- Leverage and continuously improve PPM business processes and program management methodologies.
- Develop and maintain the PPM resource library (templates, tools etc.) and improve it based on use and feedback by the TRTs.
- Collaborate with Regulatory Operations and colleagues in PTR and PDR for regulatory submissions as needed.
- Train and onboard peers and TRT members in the principles of Project Management and standardized processes for TRT operations.
Summary of Qualifications:
- BA/BS or MS in Scientific, Technical, Engineering or Business discipline. Advanced degree preferred.
- A minimum of 8-10 years’ total work experience with at least 5 or more years’ relevant experience in project management within the pharmaceutical/biotech/medical device industry with a sound knowledge of drug development processes.
- Project, Program, or Portfolio Management certification is preferred but not required. Knowledge of Project Management methodologies, concepts, techniques and tools is required.
- Prior experience with programs and portfolios in a strategic context is a plus.
- Prior regulatory experience preferred.
- Six Sigma or other OE-related certifications a plus.
- Ability to travel up to 20%
- Demonstrates, or has proven abilities to demonstrate PTR and Core Competencies.
- Strong influencing, organizational and interpersonal skills; consistently achieves targeted results without authority and by leveraging his/her expertise, business knowledge, and relationships.
- Strong partnering skills; has exceptionally strong and highly effective working relationships with internal and/or external customers and stakeholders.
- Understands key change management concepts and methodologies.
- Must work well as member of a diverse global team and in a proactive, positive and collaborative manner; Ability to manage cross-functional teams.
- Outstanding project management, planning, organization, prioritization and time management skills. Can effectively and efficiently manage and complete multiple, large-scale and complex priorities and projects on-time and on-target.
- Able to deal with ambiguity and constant change.
- Able to work independently with minimal supervision.
- Able to function effectively and in an agile manner in a fast-paced, multi-tasking environment.
- High level knowledge of regulatory requirements, manufacturing or technical development processes.
- Highly Competent in MS office applications including Excel, PowerPoint, Word, Project and Smartsheet or other PM tools.