1475 Grandview Dr., Building 35, SSF02
South San Francisco,
Industry: Clinical & Scientific
Job Number: 16227
Bayside Solutions is seeking a ICF Global Document Coordinator to be part of our client’ s team in South San Francisco. 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.
ICF Global Document Coordinator:
- 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:
- Assist in the design, implementation, and execution of process that will enable complete collection of ICF natural language content across designated regions/affiliates
- Regular review of effectiveness, quality and simplification of the collection process
- Build assessment criteria & requirements for collection and administration of collected materials
- Regular reporting through ongoing observation, monitoring and evaluation of progress.
- This includes generating, tracking, and compiling performance reports for analysis
- Supports program lead, including QC and sanity-checking of collection process and documentation created by affiliates
- Schedules and coordinates check-in meetings, workshops and global team meetings
- Tracks, manages and communicates action item status and completion with team
- Regularly consults with program lead, team, cross-functional partners and other stakeholders to remain current with relevant business, project or other developments as well as keep others apprised of project status
- As needed, develops and distributes presentations and other materials/information
- Completes other routine and ad-hoc analysis and reporting.
- Responsible to keep all internal stakeholders up-to-date with progress and interim updates.
- Following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
- Consistently complies with all governing laws, regulations, SOPs and other guidelines
Summary of Qualifications:
- Bachelors’ Degree preferred
- Demonstrated ability to organize and work with large amounts of data
- Demonstrated skills with gSuite, Excel and/or Powerpoint.
- Ability to facilitate small group feedback sessions
- Understanding of document management/change control lifecycle
- Detail-oriented, including demonstrated ability to copy edit /proofread
- Knowledge of, and/or training in, regulatory and system compliance is preferred
- Understanding of, or aptitude to learn, international regulations, processes and issues in drug development. Includes understanding of, or aptitude to learn, GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), and related systems that support clinical trials and clinical operations processes
- Knowledge of clinical, non-clinical information systems is strongly preferred
- Some knowledge of best practice project management