StemExpress
  • 13-Jul-2021 to 21-Nov-2021 (PST)
  • Quality and Compliance
  • Folsom, CA, USA
  • Full Time

About Us

The Mission at StemExpress is to accelerate the cure and prevention of significant medical conditions at life-changing speed. In 2010, the company was created to expedite research and clinical trials through the implementation of our own stem cell collection centers and state-of-the-art cell manufacturing laboratories. We support medical research, gene therapies and clinical trials by collecting human bone marrow and blood cells from our donors and sending to our clients. We provide expediency from order to delivery and guarantee every sample arrives with the highest purity, viability, and quality that researchers need to ensure confidence in their results. By shortening the time it takes to collect samples or isolate primary cells, we can help reduce months, and even years off a project. That means new cures and treatments can reach patient care faster, giving months and years back to the people afflicted with serious medical conditions.

In addition to our company's core cell and gene therapy initiatives, in 2020 we began partnering with hospitals and public health departments to provide end-to-end COVID-19 testing using gold-standard PCR.

The Role:

You will help develop and implement programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.

Duties and Essential Job Functions:

  • Prepares, reviews, and completes regulatory submissions for CLIA, FDA, Biologics and other regulatory authorities.
  • Collaborates with sponsor, study start up, clinical and regulatory staff to ensure that all regulatory documents required for site IP approval are collected and reviewed in a timely fashion.
  • Prepares and submits serious adverse events (SAEs) and Safety Reports, Medical Device Report (MDR), Development Safety Update Report (DSUR), Clinical Evaluation Report (CER) Clinical Study Reports (CSR), Unanticipated Adverse Device Effects Reports (UADEs).
  • Provides updates and communicates with sponsor, project manager, study start up and clinical team to anticipate, identify and resolve issues.
  • Assists Associate Director, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency(ies).
  • Identifies and interprets regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
  • Identifies essential regulatory documents required for execution of both domestic and global clinical research studies involving drugs, device, and combination products.
  • Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
  • Ensures the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
  • Provides regulatory guidance and quality assurance assessments for assigned research projects - domestic and international.
  • Develops training modules and presentations to ensure compliance with applicable regulatory regulations, CFR, FDA/ICH guidelines, GCP, Essential Regulatory Documents and project specifications.
  • Creates SOPs, Work Instructions, and procedures for Regulatory Operations, as needed
  • Serves as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities, as appropriate.
  • Serves as liaison with central IRBs.
  • Serves as a mentor for coworkers and trains others on tasks and/or systems.
  • Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international.
  • Ability to understand and communicate regulatory requirements for different therapeutic areas and countries and associated submission pathways.
  • Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.
  • Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards.
  • Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
  • Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.
  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
  • Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
  • Ability to read and synthesize technical material and to prepare clear and concise written documents.
  • Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.

Minimum Qualifications:

  • Requires Bachelor's degree with at least 5 years of related work experience, science degree preferred or equivalent level of education and work experience.
  • Five or more years of work experience in areas relevant to regulatory affairs, quality assurance, and clinical research.
  • Excellent analytical and communication skills, particularly writing skills, are essential.
  • Demonstrated computer literacy is required.
  • Ability to travel domestic and international.
  • Very limited physical effort required to perform normal job duties.

StemExpress is an equal opportunity employer that is committed to diversity, and values the ways in which we are different.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristic protected by applicable law.
StemExpress
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