14 Senior Regulatory Affairs Associate – 100% Remote Jobs in Thousand Oaks, CA
SPECTRAFORCE is Hiring a Remote Senior Regulatory Affairs Associate – 100% Remote
Duration: 12 monthsDescription
- Senior Associate role within RIMS Team (GRAAS Organization).
- In order to support our team's ongoing projects, we are seeking a candidate who is comfortable with learning new systems, has experience managing content in SharePoint, has working experience with the Six Sigma methodology, process mapping and project management experience.
- Our team is looking for a candidate who is able to work standard hours (ex. 7a-4p or 8am-5p etc.), with EST timezone preferred. The candidate would need to have flexibility to shift their hours to start and end their day at a later time, if additional support is needed for the PST timezone.
- Good communication skills (verbal & written)
- Resourceful critical thinker
- Experience in process mapping and detail/data quality-focused
- Regulatory Affairs understanding is highly preferred
- Any regulatory certifications (RAC) are desirable
- Interest in technical aspects of systems i.e. SQLs etc. will also be considered
- Works well collaboratively.
- Detail oriented
- Comfortable learning new systems/processes
- Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives.
- Work with stakeholders to gather requirements and develop solutions.
- Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base.
- Develop and deliver training materials and presentations to a global audience.
- Author/review/approve quality Regulatory Information Management & Systems documents
- Analysis of the existing documentation and process explore avenues to simplify and streamline.
- Provide operational support for Regulatory Data Management, Submissions, and EU CTR.
- Develop and implement process improvements and automation.
- Lead and/or support team projects.
- Organize and present data in user-friendly, graphical, interactive informational summaries that illustrate how GRAAS is performing and allow us to understand and improve business performance
- Utilize the Six Sigma method to support team processes.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
Job Summary
Full Time
$97k-124k (estimate)
08/02/2024
09/26/2024
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