Project Coordinator I
South San Francisco, CA | Contract
Bayside Solutions is seeking a Project Coorindator I to be part of our client’ s team in South San Francisco. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.
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.
Project Coordinator I
- 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:
- Supports the deployment of the PDQ QS Service model for all supported business functions (gRED, pRED, PD, GPS and affiliates).
- Ensure timely development and rollout of controlled documents according to the service model and ensure they are compiled and issued on time and periodic status updates are prepared and reported.
- Ensures CD updates and revisions are adequately communicated to business stakeholders.
- Collaborates proactively with the training team within PDQ for the proper training implementation strategy.
- Uses innovative IT tools and User Interface solutions required to support the maintenance and usability of the controlled documents in a compliant and efficient manner.
- Ensures first Level support issues (e.g., user requests, change control) are resolved in a timely manner.
- Builds and maintains strong relationships with key business stakeholders and ensures that PDQS is providing efficient, effective, value added training support to the functions.
- Identifies and follows up on issues and delays through robust SOP compliance metrics and reports.
- Ensures that business partner expectations for SOP rollout and deployment are met.
- Contributes to the PDQ QS SOP Team to set strategies and achieve the long-term goals & objectives for PDQ QS and PDQ as a whole.
- Bachelor degree in Science-related subject or other related field
- 3-5 years in the pharmaceutical industry, preferably development and working in a GxP regulated area; broad understanding of global expectations of Health Authorities in the area of Pharma Development.
- Experience in implementing processes & procedures in a regulated area.
- Experience including oversight and administration of validated electronic systems such as ConDor or other document management systems.
- Substantial knowledge of all services and activities provided by PDQ, Change Management expertise.
- Considerable organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams
- Demonstrated knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational and planning skills.
- Solid knowledge of GCP, PV and regulatory requirements
- Customer focused approach, and highly effective teamwork and collaboration skills.
- Ability to build and maintain excellent relationships with key business partners.
- Ability for problem identification / resolution in a complex environment or potential conflict.
- Ability to analyse and simplify complex systems or processes into pragmatic solutions.
- Ability to effectively communicate, and influence without authority
- Ability to work effectively in an international multicultural matrix organization.
- Fluency in written and spoken English.